A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.

You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.

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Blood Cancer: Dose-Escalation Study of VLS-101

Lead Researcher: Paul Barr

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of the novel drug, VLS-101, across a range of dose levels when administered to subjects with previously treated relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, or Richter transformation lymphoma.

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Pembrolizumab with Lenvatinib vs. Docetaxel in Participants with Lung Cancer Growth After Chemotherapy and Immunotherapy

Lead Researcher: Ronald Maggiore

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

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Standard Combination Therapy with Niraparib in Treating Patients with Prostate Cancer

Lead Researcher: Hong Zhang

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

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A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Mantle Cell Lymphoma

Lead Researcher: Patrick Reagan

This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.

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A Drug Study of Ibrutinib + Obinutuzumab in Patients with Chronic Lymphocytic Leukemia (CLL)

Lead Researcher: Paul Barr

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

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A Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer

Lead Researcher: Marcus Noel

A prospective, open-label phase 2 trial in metastatic pancreatic cancer subjects who have failed at least one line of any prior chemotherapy. The trial is designed to evaluate the of SM-88 therapy on pancreatic cancer and will measure multiple efficacy and safety endpoints, including overall response rate, overall survival, progression free survival, relevant biomarkers, quality of life and safety. In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative will be evaluated.

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A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

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A Pilot Study of the Combination of Entinostat with Capecitabine in Breast Cancer

Lead Researcher: Ajay Dhakal

The purpose of this study is to learn about the safety and side effects of combining entinostat, an investigational drug, with capecitabine, a drug commonly used in breast cancer (BC) - in both participants with metastatic breast cancer (MBC) and then participants with high-risk breast cancer after neo-adjuvant therapy.

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A Safety Study of SEA-BCMA in Patients With Multiple Myeloma

Lead Researcher: Brea Lipe

This trial will study SEA-BCMA, a monoclonal antibody, to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SEA-BCMA should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

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A study combining two drugs, Daratumumab and Lenalidomide as Maintenance Therapy for Patients with Multiple Myeloma

Lead Researcher: Brea Lipe

Patients will be treated with Daratumumab and Lenalidomide or Lenalidomide alone for two years and then tested for minimal residual disease. Minimal residual disease is the evidence for the presence of residual malignant cells, even when so few cancer cells are present that they cannot be found by routine means. In a patient who has been treated, the detection of MRD indicates that treatment is incomplete. MRD can thus distinguish who needs intensive and potentially more toxic therapy from those who do not. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be either continue or discontinue the assigned treatment. Patients are treated for up to 7 years and followed for up to 15 years.

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A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).

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A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

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A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Lead Researcher: Marcus Noel

This study will evaluate the safety profile, tolerability, and effectiveness of the drug BMS-813160 in patients with metastatic colorectal and pancreatic cancers.

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A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

Lead Researcher: Nimish Mohile

This is a dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally (between the skin layers) or subcutaneously (under the skin) in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase. Once the highest dose with acceptable toxicity is determined from either the intradermal or subcutaneous group, an additional 40 patients may be enrolled as an expansion cohort at this dose and route of administration to confirm safety and tolerability. Separate from the dose-ascending cohort and expansion cohort described previously, and once the intradermal dose-ascending cohort is completed, up to 20 myelodysplastic syndrome (MDS) patients who are resistant to treatment with hypomethylating agents (HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks [Named MDS Cohort 1]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered every 4 weeks (Named MDS Cohort 2).

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A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

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A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

Lead Researcher: Brea Lipe

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.

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A Study of Immune Responses to the Virus That Causes COVID-19

Lead Researcher: Michael Keefer

This study will help us learn how the body's immune system responds to the SARS-CoV-2 virus. Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

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A Study of IMO-2125 in Combination With Ipilimumab in Subjects With Melanoma (ILLUMINATE-301)

Lead Researcher: Deepak Sahasrabudhe

A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on nivolumab or pembrolizumab

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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma

Lead Researcher: Adrienne Victor

The purpose of this study is to assess the clinical activity and safety of INCMGA00012, a monoclonal antibody, in participants with metastatic merkel cell carcinoma (MCC).

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A Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Lead Researcher: Deepak Sahasrabudhe

The primary objective of this study is to compare MK-6482 to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that MK-6482 is superior to everolimus with respect to PFS and OS.

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Lead Researcher: Lawrence Saubermann

The purpose of this program is to evaluate the efficacy and safety of guselkumab (an injection under the skin) in participants with Crohn's disease. Inclusion Criteria: Have Crohn's disease or fistulizing Crohn's disease for at least 3 months duration (a minimum of 12 weeks). Have demonstrated intolerance or inadequate response to conventional or biologic therapy for Chrohn's disease.

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A Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Subjects with Active Crohn’s Disease

Lead Researcher: Lawrence Saubermann

The purpose of this study is to compare the effectiveness of the drug Ustekinumab to the drug Adalimumab in patients who have moderate to severe Crohn's disease. The study will test Ustekinumab compared to Adalimumab for 56 weeks. To determine if the effectiveness of each drug, patients will come to the clinic regularly to meet with the study team, complete questionnaires, and have blood work completed.

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A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Lead Researcher: Ajay Kuriyan

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

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A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease

This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period will be available to participants who complete the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label RO7105705 treatment.

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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Lead Researcher: Lawrence Saubermann

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

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A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

Lead Researcher: Ronald Maggiore

The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

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Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Lead Researcher: Angela Girvin

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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Acute Myeloid Leukemia (AML): Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Lead Researcher: Jane Liesveld

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

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Adding an Antibody to Standard Chemoradiation in Patients with Lung Cancer

Lead Researcher: Arpan Patel

This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

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Amyloidosis: A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

Lead Researcher: Frank Passero

There are two treatment groups in this study. The study medication will be given in treatment cycles, and each cycle is 28 days long. Group A: Cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD). Group B: Daratumumab plus cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD)

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Amyloidosis: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Lead Researcher: Frank Passero

All participants will receive the same study drug. If you decide to participate, you will receive up to 24 cycles (1 cycles = 28 days) of the study drug, isatuximab, as an outpatient (meaning you will not be admitted to the hospital to receive study drug. During the first cycle (or 28 days), you will receive isatuximab on Day 1, 8, 15 and 22 by intravenous (IV) infusion (into your vein). For all other cycles (Cycle 2, up to Cycle 24), you will receive isatuximab on Days 1 and 15.

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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Lead Researcher: Yuhchyau Chen

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

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ASPIRE: Treating Children With Atopic Dermatitis (Eczema)

Lead Researcher: Julie Wolf

Researchers are seeking to understand how two standard topical treatments for atopic dermatitis affect patient-reported outcomes (itch, pain, sleep, mood, and quality of life) and parent/caregiver quality of life. Participation will last approximately 12 weeks, which will include 3 clinic visits at UR Dermatology for clinical assessment of atopic dermatitis and the completion of electronic questionnaires by the child with atopic dermatitis and a parent/caregiver. Payment for participation is up to $130 if all visits are completed. You may be eligible if: You have a child between 2 to 15 years of age with a clinical diagnosis of mild to moderate Atopic Dermatitis. Your child does not have a diagnosis of another skin disease.

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Aspirin in Preventing Recurrence of Breast Cancer

Lead Researcher: Kristin Skinner

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

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Assessment of Patients with Brain Tumors, Ages 65+

Lead Researcher: Andrea Wasilewski

The purpose of this study is to collect information about the physical function, thinking, independence, social support, and medications of older patients with brain tumors in order to develop more specialized treatments and support for that population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender; Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started radiation or chemotherapy for brain tumor treatment

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Axillary Reverse Mapping in Preventing Lymphedema (Swelling) in Patients With Breast Cancer

Lead Researcher: Kristin Skinner

This phase III trial studies how well axillary reverse mapping, a visualization technique with a blue dye, works in preventing lymphedema (a swelling condition) in patients with breast cancer that are undergoing dissection of lymph nodes in the armpit. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

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B-Cell Acute Lymphoblastic Leukemia: Adding Inotuzumab Ozogamicin to Chemotherapy

Lead Researcher: Angela Girvin

Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab.

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Baby formula and health

Lead Researcher: Bridget Young

Participation in this study involves one visit that will last for about four hours at your home or the Strong Memorial Hospital Clinical Research Center. Procedures include infant glucose test, timed infant urine collection, infant heel pricks, and infant body size measurements.

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Biomarker/ALK Inhibitor Combinations in Treating Patients With Lung Cancer

Lead Researcher: Ronald Maggiore

This National Cancer Institute (NCI)-NRG phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV, ALK positive, non-squamous, non-small cell lung cancer.ALK inhibitors like lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with lung cancer.

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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Lead Researcher: Angela Girvin

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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Bladder Cancer: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma

Lead Researcher: Chunkit Fung

The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify patients who would benefit most from INCB054828.

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Bladder Cancer: Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma

Lead Researcher: Elizabeth Guancial

If you agree to and are allowed to participate in this study, you will be assigned by 33% chance (a process called randomization similar to rolling a dice) to one of three treatment groups: • Subjects assigned to Treatment Group A, will receive pembrolizumab • Subjects assigned to Treatment Group B, will receive the combination of pembrolizumab and chemotherapy (either cisplatin or carboplatin with gemcitabine). • Subjects assigned to Treatment Group C, will receive chemotherapy (either cisplatin or carboplatin with gemcitabine). Both you and your doctor will know which treatment group you have been assigned to.

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Bladder Cancer: study on a drug delivery system (TAR-200)

Lead Researcher: Chunkit Fung

TAR-200 is a drug-device product that continuously releases a chemotherapy drug (called gemcitabine) in the bladder over several days. The purpose of this study is to determine if TAR-200, when combined with a first-line treatment (a drug called nivolumab) is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC).

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Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Blood Cancer: A Study of APTO-253 in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrom (MDS)

Lead Researcher: Kristen O'Dwyer

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

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Brain Training to Promote Health in Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to determine whether two types of in-home “brain-training” programs may have beneficial health effects, including reduced stress and improved immune health, for individuals caring for a loved one (spouse, parent, friend, etc) who has dementia. Participation involves completing one of our brain training programs with the use of a computer at home a few times a week (when convenient for you), over eight weeks. Experience or skill with computers is not necessary. If you do not own a computer, one may be provided for you to use during the program period.

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Breast Cancer Weight Loss Study (BWEL Study)

Lead Researcher: Kristin Skinner

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

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Breast Cancer: MK-3475 as Adjuvant therapy for Triple Receptor-Negative Breast Cancer or Positive Lymph Nodes After Neoadjuvant Chemotherapy - S1418

Lead Researcher: Alissa Huston

The purpose of this study is to compare treated subjects' invasive disease-free survival of patients with triple-negative breast cancer after neoadjuvant chemotherapy.

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Breast Cancer: Predictors of Chemotherapy Side Effects in Older Adults

Lead Researcher: Supriya Mohile

The purpose of this study is to understand how a person’s physical function (ability to complete daily activities at home and in the community) changes over time.

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Breast Cancer: Radiation Therapy with the Oral Drug Olaparib

Lead Researcher: Ajay Dhakal

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

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Cabozantinib S-Malate in Treating Patients With Neuroendocrine Tumors

Lead Researcher: Aram Hezel

This randomized phase III trial studies cabozantinib S-malate to see how well it works compared with placebo in treating patients with neuroendocrine tumors that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery after previous treatment with everolimus. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

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Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving Chemotherapy: A Pilot Study Evaluating Feasibility And Impact

Lead Researcher: Allison Magnuson

In Phase I all subjects will receive cognitive rehabilitation intervention which includes, workshops and at-home computer-based cognitive training. In the phase II portion of the study, depending on the group you are assigned, you may receive cognitive rehabilitation intervention or usual care. This will help researchers develop a doable approach to cognitive rehabilitation and see if it helps reduce the risk of developing progressive cognitive impairments which is a common side effect of chemotherapy.

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Cancer: Geriatric Assessment and Clinical Outcomes in Older Oncology Patients (SOCARE)

Lead Researcher: Supriya Mohile

We are asking for your participation in this study not as consent to undergo this testing (as it is undertaken for all new patients), but so that we may follow your evaluation results, and determine how this testing influences our shared decisions regarding your care and treatment. This information is useful, as it is understood that older patients (greater than or equal to 65-years old) often have different levels of health, and outside challenges that can influence their care. Historically, older patients have not received equal treatment for cancer and may be at greater risk for possible side effects from treatment. It is our hope that these tools, well-established at identifying areas of risk, will provide meaningful opportunities of intervention that will promote your safety.

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Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

Lead Researcher: Michael Keefer

The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine. Inclusion Criteria: Age 18 or older / Have had a positive test for SARS-CoV-2 / Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment.

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Chemoradiotherapy with Atezolizumab (Monoclonal Antibody) for Treating Bladder Cancer

Lead Researcher: Yuhchyau Chen

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

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Chronic Pain Study

Lead Researcher: Paul Geha

This study will use subjective rating methods, computer-based games, and brain imaging to study the characteristics of chronic pain and brain processes that cause them. By so doing we hope to obtain new information and understanding of chronic pain across multiple conditions. Eligibility: Ages 18-65; in generally stable health; diagnosed with a pain condition: Chronic back pain (CBP), Osteoarthritis of the knee (OAk), Temporomandibular joint disorder(TMJ), Complex regional pain syndrome (CRPS), or Pelvic Pain (PP).

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Collecting Breast Milk Samples for Future Research

Lead Researcher: Kirsi Jarvinen-seppo

When some research ideas are initially formed, they need to be tested on small amounts of human breast milk before moving on to large studies. This study will collect a one-time breast milk sample and questionnaire from each participant for that purpose. Participants will be compensated $5 per breast milk sample (up to 4 samples). Additionally, this study will collect multiple breast milk samples from two different groups of mothers who can collect samples at home. The first group will help us learn more about food allergies by collecting samples before a meal and 1, 2, 6, and 24 hours after a meal containing one egg, one cup of milk, or a small handful of peanuts. If a woman is experiencing COVID-19 symptoms, they may join a different group that will provide samples over time to help us learn how long the virus is present in breast milk.

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Colorectal Cancer: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer

Lead Researcher: Marcus Noel

This study has 3 study groups. A computer will, by chance assign you to one of the groups in the study. This is done because no one knows if one study group is worse or better than the others. You will have an equal chance of being in groups 1, 2, or 3. Group 1 will get FOLFOX and bevacizumab, Group 2 will get atezolizumab alone and Group 3 will receive FOLFOX and bevacizumab plus atezolizumab. The drugs will be given by infusion.

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Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

Lead Researcher: Marcus Noel

If you decide to participate in this study a computer will assign you to one of the 3 study groups. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive the study drugs trastuzumab and pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not approved by the FDA for treatment of colorectal cancer). These drugs will be given through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy, cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are in Group 2 and your cancer gets worse, you may have the option to receive the same treatment as Group 1, and be placed into Group 3.

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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

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Combination Treatment for Lung Cancer with STK11 Gene Mutation

Lead Researcher: Megan Baumgart

This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.

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Combining Immune Therapy, Pembrolizumab, and Chemotherapy as First Line Treatment for Lung Cancer

Lead Researcher: Megan Baumgart

The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.

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CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-Surgery Chemo and Targeted Therapy

Lead Researcher: Ajay Dhakal

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.`

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Connect® MDS/AML Disease Registry

The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into treatment regimens and sequencing of these regimens as they relate to clinical outcomes of patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate molecular and cellular markers that may provide further prognostic classification and/or might be predictive of therapy outcomes.

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Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)

Lead Researcher: Martin Zand

The purpose of this study is to is to determine if convalescent plasma will help a person with COVID-19 symptoms improve and prevent admission into the hospital. Convalescent plasma is plasma from a person who has recovered from a COVID-19 infection. Participants in this study will receive either control or convalescent plasma. COVID-19 symptoms include but are not limited to fever, cough, or loss of taste or smell. You must be 18 years or older to participate.

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Convalescent Plasma to Stem Coronavirus in COVID negative participants (CSSC-001)

Lead Researcher: Martin Zand

This study will determine if plasma collected from the blood of people who have recovered from COVID-19 infection will help others who are at risk for getting COVID-19. Participants should be people who are at high risk for COVID-19 infection. They will receive a one-time infusion of convalescent or control plasma. Convalescent plasma is from a person who has recovered from a COVID-19 infection. Plasma will not have COVID-19 but will have antibodies to the virus. The purpose of this study is to determine if these antibodies will help keep people who are at high risk for getting COVID from getting infected. To be eligible you must have had close contact with someone who is COVID-19 positive and have a high risk for illness such as >=65, reside in a nursing home or long-term care facility, have chronic lung disease, asthma, heart disease, obesity, uncontrolled diabetes, renal failure, liver disease or cancer. Or you must be a healthcare professional with high risk exposure such as have had prolonged close contact with patients with COVID-19 who were not wearing a facemask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.

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COVID-19 and Breastfeeding Mothers

Lead Researcher: Bridget Young

We are seeking breastfeeding moms - with a baby under 6 months old - who have recently been diagnosed with COVID-19, ideally within the previous 7 days. The purpose of this study is to determine if there may be COVID-19 virus in various samples we collect from mother and child. These samples include mother’s breast milk, skin swab, saliva, and blood sample, as well as infant stool samples. These will be taken within certain windows of time at your convenience inside the home. Participation in this study will be for 90 days. You will be reimbursed a total of $60 ($30 after day 10 collection and another $30 after the day 90 collection) via check.

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COVID-19 Vaccine Studies

Lead Researcher: Ann Falsey

URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900. Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer, take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK

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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

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Describing the Infection/Illness Mechanisms for Influenza and COVID-19

Lead Researcher: Angela Branche

This study will obtain timed samples of blood and nasal secretions from adults, children, and the elderly with influenza-like illness. It will look to characterize the pathogenesis (mechanisms of infection/illness) and the responses that occur within the immune system - for both COVID-19 and influenza.

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Developmental Impact of NICU Exposures (DINE)

Lead Researcher: Gloria Pryhuber

Entry into the DINE study requires prior enrollment in the Prematurity and Respiratory Outcomes Program (PROP) or the Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts/PRISM study. If you have not participated in these studies in the past you will not be eligible for this trial. The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

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Diffuse Large B-Cell Lymphoma (DLBCL): A Study of Brentuximab Vedotin Incorporated into Reduced-Dose Chemotherapy in Elderly Patients

Lead Researcher: Patrick Reagan

This study incorporates brentuximab vedotin into dose-reduced chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) as initial therapy for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). Vincristine, which is typically part of the standard chemotherapy regimen, will be omitted due to overlapping toxicities with brentuximab vedotin.

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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Lead Researcher: Alissa Huston

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane

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Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Lead Researcher: Angela Girvin

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

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Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma

Lead Researcher: Omar Aljitawi

Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. Eligible patients who choose to participate will be randomized so that half receive one hyperbaric oxygen therapy session prior to hematopoetic stem cell infusion and half will not. All subjects will have their blood counts monitored closely and time to count recovery will be compared between the two groups.

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Endometrial Cancer: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Lead Researcher: Richard Moore

If you decide to participate in this study, you will be assigned by chance to get either lenvatinib plus pembrolizumab or doxorubicin or paclitaxel. You will know what treatment you will be assigned to receive.

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Engage Coaching to Promote Connectedness in Caregivers

Lead Researcher: Kimberly Van orden

Adults (age 50 or older) who are providing care for someone with dementia will participate in what we call ‘Engage Coaching.’ This involves meeting with an Engage Coach up to 8 times. Typically, meetings will occur weekly, but you will have up to three months to complete your sessions. These meetings are brief (approximately 30 mins) and can be done in your home or wherever is convenient for you, including via phone if needed. The coaching is designed to help you enhance your relationships and improve well-being while managing caregiving stress. Your coach will help you identify aspects of your social relationships that are helpful to you and aspects that are not. Using this information, your coach will help you identify goals for improving your social relationships. Each session, your coach will help you complete a process we call ‘action planning,’ in which you set a goal for the week, brainstorm strategies to meet the goal, and identify concrete steps to take to achieve the goal. You will work with your coach to identify any aspects of caregiving that may present barriers to improving your relationships and develop strategies to address these barriers. Participants will also complete two follow-up interviews after completing the coaching--three months after enrolling in the study (after completing Engage Coaching) and six months after enrolling.

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ENLITE PD: Light Therapy for Impaired Sleep in Parkinson's Disease Patients

Lead Researcher: Jennifer Marsella

The study goal is to determine the best dose of light therapy needed to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day. Eligibility: Diagnosis of Parkinson's Disease; Significant sleep problems; Willing to wear an Actiwatch and complete daily sleep logs; Age 45 or above

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Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Evaluating Social Networks for Adults with Advanced Cancer: A Pilot Feasibility Study

Lead Researcher: Supriya Mohile

The purpose of this study is to learn how older adults with cancer seek information from their social networks (family, friends, clergy, or other people they are close with) and how they use information they’ve gathered to make decisions about treatment for their cancer.

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Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia

Lead Researcher: Richard Dunne

In this study the investigator would like to better understand how cachexia (weight and muscle loss) may improve or worsen, and how exercise and nutritional supplements may impact this process. The investigator would like to see whether a nutritional supplement (Remune) with or without a walking and progressive resistance exercise program (EXCAP©®, Exercise for Cancer Patients) can improve symptoms in patients with lung or gastrointestinal cancers with weight loss and cachexia. The investigator would also like to find out if this nutritional supplement and exercise intervention improves physical performance, day-to-day function, quality of life, and how the supplement and/or exercise may affect different markers in the blood over time.

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Evaluation of Chemotherapy (Carboplatin) Dosing with Contrast Agent, Iohexol

Lead Researcher: Richard Moore

This trial studies how well iohexol, a contrast agent, works in helping doctors calculate the dose of carboplatin given to patients with cancer. A contrast agent is a substance used to increase the contrast of structures or fluids within the body in medical imaging. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future.

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Follow-up Visit of High Risk Infants

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

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Future Contact Database/Repository for Allergy, Immunology, and Rheumatology Research

Lead Researcher: Jennifer Anolik

Autoimmune diseases affect the immune system and are typically chronic conditions in which the immune system has an overactive response against substances and tissues that are normally present in the body. How autoimmunity develops, progresses, induces immunological abnormalities and leads to disease remains largely unknown, producing the need for further research. However, because the necessary samples are unique and somewhat rare, the ability to do research can at times be hindered. One purpose of this protocol is to establish a database that will serve as both a contact and research database. Subjects who are currently participating in one of our studies as well as those who are interested in participating in future research at the University of Rochester will be consented so that we may store their personal information in a division database. We will also store data collected during the conduct of IRB approved studies which reference this protocol. Healthy controls and individuals with diseases affecting the immune system may be consented and enrolled into this protocol.

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Gastrointestinal (pancreas) Cancer: Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Lead Researcher: Marcus Noel

Glufosfamide is being compared against Fluorouracil (5-FU). Fluorouracil is approved by the FDA for use in people with rectal cancer. 5-FU was the drug of choice for pancreatic cancer before gemcitabine and is still used in multiple regimens such as folfox and Folfirinox as part of standard of care. The study drug is made of glucose (a sugar made by the body) and a substance which damages or kills cancer cells. Cancer cells depend on sugar more than normal cells do, so the cancer cells may take up more of the study drug than normal cells. This may allow glufosfamide to attack the cancer cells without causing excessive damage to the normal cells.

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General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

Lead Researcher: Jacob Nadler

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

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Generic Database of Very Low Birth Weight Infants

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

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Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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Gilteritinib vs Midostaurin in Acute Myeloid Leukemia

Lead Researcher: Kristen O'Dwyer

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 65 will be randomly assigned to receive gilteritinib or midostaurin. Patients will also receive standard chemotherapy of daunorubicin and cytarabine. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.

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Gynecologic (cervical) cancer: Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

Lead Researcher: Richard Moore

You will get either standard treatment with radiation therapy OR standard treatment with radiation therapy with the addition of cisplatin chemotherapy.

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Head and Neck Cancer: Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

Lead Researcher: Ronald Maggiore

The purpose of this study is to compare two treatment approaches that are currently used after surgery for head and neck cancer. One approach is to administer radiation therapy alone. A second approach is to administer radiation therapy along with the chemotherapy drug, cisplatin.

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Hematopoietic Stem Cell Transplantation: Evaluation of Investigational Cryopreserved Cord Blood Units (CBUs)

Lead Researcher: Omar Aljitawi

The purpose of this study is to document and evaluate all problems that may occur with the use of investigational cord blood units. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems. The cord blood units in this study have been collected, processed, tested and stored by the National Cord Blood Program and meet the criteria for transplantation as approved by NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).

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HOPE-Helping Older People Engage

Lead Researcher: Kimberly Van orden

The purpose of this study is to compare two activities — reflecting on one’s past (called “life review”) and volunteering in the community (“volunteering”). We are interested in learning how these activities may improve social connectedness and well-being among adults age 60 and older. Additionally, we may ask questions about social distancing, so to that end this study is relevant to managing the psychosocial implications of COVID-19. Volunteering involves participate weekly in a flexible volunteer program with Lifespan that involves a menu of options including helping at senior centers, co-leading classes, mentoring/tutoring and many other options. Life review involves participating in a one-year reminiscence program that is self-guided and involves completing monthly exercises such as writing about one’s memories.

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Hydrocortisone for premature babies

Lead Researcher: Carl D'Angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant

Lead Researcher: Omar Aljitawi

Subjects with Acute Myeloblastic Leukemia (AML) and myelodysplastic syndrome (MDS) who are considered eligible for allogeneic stem cell transplant by the transplant team at WCI (Wilmot Cancer Institute) will be enrolled in the study. Patients will receive Melphalan on day -2 and HBO (Hyperbaric Oxygen) therapy on day 0 of the transplant. After neutrophil recovery is documented, the patients will be seen in clinic at least weekly through day +100.

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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia

Lead Researcher: Paul Barr

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.

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Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

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Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

Lead Researcher: Jonathan Friedberg

This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

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Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Lead Researcher: Deepak Sahasrabudhe

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

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Immunotherapy in Treating Patients With Stage III-IV Skin Cancer

Lead Researcher: Adrienne Victor

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better in treating melanoma.

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Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Lead Researcher: Michael Becker

Following enrollment, patients will be CD34+ stem cell mobilized with plerixafor, at the discretion of the treating attending physician, for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned autologous stem cell transplant (ASCT). Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guidelines.

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Improving Risk Assessment of Acute Myeloid Leukemia (AML) With a Precision Genomic Strategy to Assess Mutation Clearance

Lead Researcher: Eric Huselton

The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.

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Improving Well-Being for Older Adult Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program, compared to any usual care, to see if the programs might be associated with better immune function, physical and emotional health, and well-being. This study is looking for individuals age 55 and up who are caring for a loved one (such as a spouse, parent, close friend) who has dementia. Participation includes attending a weekly small group meeting over eight weeks for one of two study programs (determined randomly). Both programs address ways of improving physical and emotional well-being in the context of dementia caregiving.

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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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Induction Chemotherapy for Locally Advanced Esophageal Cancer

Lead Researcher: Richard Dunne

Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.

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Infant Allergy Study

Lead Researcher: Kirsi Jarvinen-seppo

The purpose of this study is to provide new knowledge about the development of infant immunity, and set the groundwork for future studies in the prevention of allergic diseases in childhood. We can study the difference between populations with allergic diseases and those without allergic diseases by comparing breast milk, saliva, blood, skin swab, nasal swab, urine, and stool samples. Eligibility: You need to be 18 years or older, healthy, and pregnant. If you have allergies, such as hay fever, asthma, eczema, or food allergies in the family (you, your partner, or another child), then you may qualify for this study.

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Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Leukemia (ALL): Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

This study will have 2 groups: subjects who do not have the Philadelphia chromosome mutation (Ph-) and subjects who do have the mutation (Ph+). Treatments for the two groups will be different and are outlined below. In general, there are 3 main steps to all of the treatments. Induction/Re-Induction treatment is given first. It is a treatment given over a short period of time (usually only a few months) to get rid of as many of the leukemia cells as possible very quickly. Post-Remission treatment is given next. It is given to get rid of any leukemia cells that are left once your leukemia goes into remission and to make sure the leukemia cells don’t come back over a short period of time (usually only a few months). Maintenance treatment is given last. It is a lower dose treatment given over a long period of time (up to several years) to help keep the leukemia cells from coming back. Depending on which arm of the study you are on, Blinatumomab will be given as part of induction/re-induction or post-remission along with standard chemotherapy.

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Leukemia: Characterization of the bone marrow microenvironment in patients with myelodysplastic syndrome (MDS)

Lead Researcher: Michael Becker

This study is being performed to begin to understand the interactions between MDS tumor cells and the normal bone marrow supporting cells, termed the bone marrow microenvironment.

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Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

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Lung Cancer: Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer

Lead Researcher: Megan Baumgart

If you decide to participate in this study you will be assigned to one of the two treatment groups by chance. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive the study drug nivolumab in combination with the usual chemotherapy regimen of platinum (cisplatin or carboplatin) and etoposide administered by an intravenous (IV) infusion. Group 2 will receive the usual chemotherapy alone administered by an intravenous (IV) infusion.

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Lung Cancer: First-Line Treatment of M7824 Versus Pembrolizumab

Lead Researcher: Deborah Mulford

The study will evaluate M7824 monotherapy versus pembrolizumab as first-line treatment for participants with advanced non-small-cell lung carcinoma (NSCLC) with high PD-L1-tumor expression (PD-L1 stand for Programmed Death-Ligand 1).

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Lung Cancer: VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer (CLASSICAL-Lung)

Lead Researcher: Megan Baumgart

There are 2 phases in this study. If you are in the dose finding phase of the study, the dose level of VX15/2503 that you receive is depends on when you enter the study. The first group of subjects in this study will get a low dose of VX15/2503. If that dose is well tolerated by those subjects, then the next group of subjects will get a higher dose of VX15/2503. This will continue until the highest tolerable, safe dose of VX15/2503 is reached. The dose expansion phase will begin begin after the highest tolerable dose, or recommended phase 2 dosage (dose to be tested in expansion), has been identified in the dose finding phase of the trial.

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Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes data in patients with hematological malignancies

Lead Researcher: Walter Burack

This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.

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Lymphoma (Diffuse Large B Cell): A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL) (ZUMA-7)

Lead Researcher: Patrick Reagan

If you decide to participate in this study, you will be randomized or assigned to one of two study groups based on your previous response to therapy and the International Prognostic Index score, a tool used to predict the likely course of your disease. The Experimental Treatment Group will undergo collection of white blood cells by a process called leukapheresis in order to manufacture your T cells into axi-cel, three days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study Doctor believes the current status of your disease is rapidly progressing, you may receive steroid therapy while axi-cel is being manufactured. The Standard of Care (SOC) Treatment Group will receive standard of care therapies including two or three cycles of second-line platinum-based combination chemotherapy regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP (Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone, Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy treatment, you will also receive high dose therapy and ASCT per your Study Doctor.

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Lymphoma (DLBCL): A Study Comparing the Efficacy & Safety of Polatuzumab Vedotin w/ Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone vs Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, & Prednisone in Diffuse Large B-Cell Lymphoma (POLARIX)

Lead Researcher: Patrick Reagan

If you decide to participate in this study you will be randomly assigned by a computer program to one of the following treatment groups: polatuzumab vedotin and R-CHP with placebo, or R-CHOP with placebo. Since the difference between the treatment groups is polatuzumab vedotin in one group and vincristine (O) in the other, both groups will receive a placebo, which is a substance that looks like either polatuzumab vedotin or vincristine but contains no active medication. Neither you nor your study doctor may choose the group that you will be in. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know which treatment you receive.

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Lymphoma (iNHL): A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma (ILyAD)

Lead Researcher: Jonathan Friedberg

If you decide and are eligible to take part in this study, in addition to the standard treatment, rituximab, you will be randomized to receive an oral dose of either 2,000 IU vitamin D (also called cholecalciferol) supplementation or placebo. The randomization will be 2:1. A 2:1 randomization means for every three people enrolled on the study, two people will receive vitamin D and one person will receive placebo. This study is conducted in a double blind fashion, which means neither you nor your doctor will know which treatment group you are in.

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Lymphoma/Leukemia (CLL/SLL): A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL

Lead Researcher: Paul Barr

If you decide to participate in this study; as part of the screening tests for the study, your blood will be tested to determine whether you have CLL/SLL that has a mutation (a change) in one of the chromosomes called ‘17p deletion’. If you have CLL/SLL that does not have the 17p deletion, you will be in Cohort 1 and will be randomly assigned by a computer program to one of the following treatment groups in Cohort 1: BGB-3111 or B+R. When you are “randomly assigned” it means you are put into a group by chance, like flipping a coin. Neither you nor your study doctor may choose the treatment you will take. You will have an equal chance of receiving either treatment in Cohort 1. If your CLL/SLL has the 17p deletion, you will be assigned to Cohort 2 and will receive BGB-3111.

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Lymphoma: A Safety and Efficacy Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

Lead Researcher: Paul Barr

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in combination with brentuximab vedotin. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Brentuximab vedotin is an antibody-drug conjugate (a type of human protein linked to a study drug). The antibody part of the drug binds to CD30 which often occurs on diseased cells but rarely on normal tissues.

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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Lead Researcher: Angela Girvin

This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

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Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

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Management of the PDA Trial

Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.

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Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Lead Researcher: Michal Lada

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

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Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post‐surgical outcomes in patients undergoing radical cystectomy. The goals of this initiative are to obtain a detailed baseline of multiple patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

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Melanoma: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

Lead Researcher: Deepak Sahasrabudhe

The BRAF inhibitor component will include two drugs dabrafenib and trametinib that each have been approved by the FDA for the treatment of this patient population and have also been approved for use in combination due to superior effects relative to the single agent treatments. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence.

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MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

Lead Researcher: Marcus Noel

This study is designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with relapsed/refractory metastatic colorectal carcinoma. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) - MAD; if no MTD is defined - of the drug combination, followed by a Cohort Expansion Phase to further define the safety and initial anti-tumor activity of the drug combination with the doses established in the Dose Escalation Phase.

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Milrinone in Congenital Diaphragmatic Hernia

Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.

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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Apnea of prematurity (AOP) is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

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Monoclonal VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer

Lead Researcher: David Linehan

This randomized phase I trial studies how well a monoclonal antibody, anti-SEMA4D monoclonal antibody VX15/2503, works in treating patients with stage I-III pancreatic cancer. It will be used with or without another monoclonal antibody, ipilimumab or nivolumab. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

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Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS

Lead Researcher: Eric Huselton

This is a multi-center, single-arm, open-label, phase II trial for the frontline treatment of relapsed AML or MDS following allo-HCT. Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.

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Multiple Cancers: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Lead Researcher: Marcus Noel

This study has 2 phases; depending on when you are enrolled into the study and what type of cancer you have, you will participate in 1 of the 2 phases. Phase 1 is the “Dose Escalation” portion of the Study. Certain dose levels of INCAGN01949, when given together with nivolumab and/or ipilimumab, will be evaluated in small groups of subjects (also called “cohorts”) with advanced or metastatic cervical cancer, uterine cancer, stomach cancer, throat cancer, liver cancer, specific types of skin cancer, a specific subtype of colon cancer, lung cancer, ovarian cancer, head and neck cancer, kidney cancer, a certain type of breast cancer, and bladder and urinary tract cancer. Subjects will be observed for a minimum of 28 days before the dose is increased for the next cohort. Phase 1 subjects will enroll into 1 of 3 different Study Drug Combination groups. Enrollment in this phase of the Study will continue until the highest dose of INCAGN01949 that is safe and tolerated by most subjects is found.Some subjects will be enrolled into safety expansion cohorts within Phase 1. These subjects will receive the same combinations and doses given in the dose escalation part of the study, however the administration of nivolumab and/or ipilimumab will begin after 2 cycles of INCAGN01949 are given. Phase 2 is the “Dose Expansion” portion of the Study. The dose of INCAGN01949 determined to be safe during the Phase 1 (Dose Escalation) portion of the Study will be given together with nivolumab and/or ipilimumab to subjects with kidney cancer or bladder and urinary tract cancer in 1 of 6 different Study Drug Combination groups. The dose of INCAGN01949 you receive in this Study will depend on the dose level being tested at the time you are enrolled. The doses of nivolumab and ipilimumab administered to you in this Study will not change.

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Multiple Myeloma

Lead Researcher: Brea Lipe

The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression. This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time. If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points. These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.

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Multiple Myeloma or Lymphoma: Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies

Lead Researcher: Brea Lipe

This research is being done to help us determine if the study drug is safe and can be tolerated for the treatment of multiple myeloma or certain lymphomas.

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Multiple Myeloma: A Study of C-220 as a Single Treatment and in Combination with Other Treatments

Lead Researcher: Brea Lipe

This is a multicenter, multi-country study consisting of two parts: Part 1) Evaluation of dosing amounts of CC-220 alone, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and CFZ; Part 2) Expansion of the highest tolerated doses of CC-220 alone, CC-220 in combination with DEX (DoubleT) for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

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Multiple Myeloma: A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

Lead Researcher: Brea Lipe

If you decide to participate in this study you will receive denosumab every 4 weeks for a total of 12 cycles.

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Multiple Myeloma: Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults with Multiple Myeloma to Drive Personalized Treatment Decisions

Lead Researcher: Supriya Mohile

If you enter the study, you will be asked to complete an electronic questionnaire on a sponsor- provided electronic tablet during an already scheduled clinical visit to your medical oncology doctor’s office. The questionnaire will take about 10 minutes to complete; study staff will remain available to assist you