A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Who is this study for? Patients with Esophageal Cancer
Status: Suspended
Location: See all (490) locations...
Intervention Type: Biological, Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• STEP 1 RANDOMIZATION: Patients must be age \>= 18 years

• STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)

• STEP 1 RANDOMIZATION: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• STEP 1 RANDOMIZATION: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy

• STEP 1 RANDOMIZATION: Absolute neutrophil count \>= 1,500/mcL (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Platelets \>= 100,000/mcL (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Serum creatinine =\< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Hemoglobin (Hgb) \>= 9 g/dL (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Leukocytes \>= 3,000/mm\^3 (within less than or equal to 14 days prior to randomization)

• STEP 1 RANDOMIZATION: Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy

• STEP 1 RANDOMIZATION: Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy

• STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy

• STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving radiation therapy

• STEP 1 RANDOMIZATION: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, must be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome must be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies must be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

• STEP 1 RANDOMIZATION: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

• STEP 1 RANDOMIZATION: Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:

‣ Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR

⁃ Prior malignancy completely excised or removed and patient has been continuously disease free for \> 5 years OR

⁃ Date of last evidence of disease

• STEP 1 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =\< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease

• STEP 1 RANDOMIZATION: Patients must have adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs

• STEP 1 RANDOMIZATION: For patients with evidence of uncontrolled CHF, myocardial infarction (MI), cardiomyopathy, or myositis, require a cardiac evaluation and clearance including lab tests and cardiology consultation (EKG, creatinine phosphokinase \[CPK\], troponin, and echocardiogram)

• STEP 1 RANDOMIZATION: Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility

• STEP 1 RANDOMIZATION: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen

• STEP 1 RANDOMIZATION: Patients must not be receiving any other investigational agents

• STEP 1 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded

• STEP 1 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants from carboplatin, paclitaxel, ipilimumab or nivolumab

‣ All patients of childbearing potential must have a blood test or urine study done within 2 weeks prior to randomization to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours of starting nivolumab to rule out pregnancy

⁃ A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

• STEP 1 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug. Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy

• STEP 2 RANDOMIZATION: Patient registration must not exceed 12 weeks from time of esophagectomy

• STEP 2 RANDOMIZATION: Patients must have a post-operative ECOG performance status of 0-2

• STEP 2 RANDOMIZATION: Absolute neutrophil count \>= 1,500/mcL (within less than or equal to 14 days prior to randomization)

• STEP 2 RANDOMIZATION: Platelets \>= 100,000/mcL (within less than or equal to 14 days prior to randomization)

• STEP 2 RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)

• STEP 2 RANDOMIZATION: AST (SGOT)/ ALT (SGPT) =\< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)

• STEP 2 RANDOMIZATION: Serum creatinine =\< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)

• STEP 2 RANDOMIZATION: Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical CT scan. Patients must also have a negative surgical margin (R0 resection)

• STEP 2 RANDOMIZATION: Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger

• STEP 2 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease

• STEP 2 RANDOMIZATION: Patients must not be receiving any other investigational agents

• STEP 2 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded

• STEP 2 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risks for adverse events in nursing infants from nivolumab or ipilimumab

‣ All patients of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to randomization to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy

• STEP 2 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug. Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Arkansas
Mercy Hospital Fort Smith
Fort Smith
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arizona
Cancer Center at Saint Joseph's
Phoenix
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PCR Oncology
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Community Cancer Institute
Clovis
University Oncology Associates
Clovis
Los Angeles General Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Stanford Cancer Institute Palo Alto
Palo Alto
VA Palo Alto Health Care System
Palo Alto
Mercy Cancer Center - Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Saint Helena Hospital
Saint Helena
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
Santa Maria
Presbyterian Intercommunity Hospital
Whittier
Woodland Memorial Hospital
Woodland
Colorado
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
Saint Francis Cancer Center
Colorado Springs
AdventHealth Porter
Denver
Saint Anthony Hospital
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AdventHealth Littleton
Littleton
Longmont United Hospital
Longmont
AdventHealth Parker
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Saint Mary Corwin Medical Center
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Washington, D.c.
MedStar Georgetown University Hospital
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Beebe Medical Center
Lewes
Beebe South Coastal Health Campus
Millville
Christiana Care Health System-Christiana Hospital
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Seaford
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AdventHealth Altamonte
Altamonte Springs
Mount Sinai Comprehensive Cancer Center at Aventura
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Holy Cross Hospital
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Kissimmee
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Miami Beach
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'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
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Queen's Cancer Center - Kuakini
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Queen's Medical Center
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Straub Clinic and Hospital
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The Cancer Center of Hawaii-Liliha
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Wilcox Memorial Hospital and Kauai Medical Clinic
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Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Greater Regional Medical Center
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Mercy Medical Center - Des Moines
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Saint Luke's Cancer Institute - Boise
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Memorial Hospital of Carbondale
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SIH Cancer Institute
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Crossroads Cancer Center
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Western Illinois Cancer Treatment Center
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Edward Hines Jr VA Hospital
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Methodist Medical Center of Illinois
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Detroit
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University of Michigan Health - Sparrow Lansing
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Livonia
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Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
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Henry Ford Health Providence Novi Hospital
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Michigan Healthcare Professionals Pontiac
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Pontiac
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Oncology Hematology Associates of Saginaw Valley PC
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Southfield
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Essentia Health - Deer River Clinic
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes
Essentia Health Cancer Center
Duluth
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Duluth
Miller-Dwan Hospital
Duluth
Fairview Southdale Hospital
Edina
Lake Region Healthcare Corporation-Cancer Care
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Fosston
Unity Hospital
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Hibbing
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Saint John's Hospital - Healtheast
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Health Partners Inc
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Mayo Clinic in Rochester
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Regions Hospital
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Saint Paul
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Cape Girardeau
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Joplin
Mercy Clinic-Rolla-Cancer and Hematology
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Phelps Health Delbert Day Cancer Institute
Rolla
Heartland Regional Medical Center
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Mercy Hospital Saint Louis
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Mercy Hospital South
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Missouri Baptist Medical Center
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Washington University School of Medicine
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Sainte Genevieve County Memorial Hospital
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CoxHealth South Hospital
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Montana
Saint Patrick Hospital - Community Hospital
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Novant Health Presbyterian Medical Center
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Novant Health Cancer Institute - Huntersville
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Matthews Radiation Oncology Center
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Novant Health Cancer Institute - Matthews
Matthews
Novant Health Cancer Institute - Mooresville
Mooresville
Novant Health Cancer Institute - Mount Airy
Mount Airy
Novant Health Cancer Institute - Wilkesboro
North Wilkesboro
Rowan Regional Medical Center
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Statesville
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Thomasville
Novant Health Forsyth Medical Center
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Essentia Health Cancer Center-South University Clinic
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Sanford Broadway Medical Center
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Sanford Roger Maris Cancer Center
Fargo
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Jamestown
Nebraska
Nebraska Medicine-Bellevue
Bellevue
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
CHI Health Good Samaritan
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Alegent Health Bergan Mercy Medical Center
Omaha
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Alegent Health Lakeside Hospital
Omaha
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Community Medical Center
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Lovelace Medical Center-Saint Joseph Square
Albuquerque
New Mexico Oncology Hematology Consultants
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Presbyterian Kaseman Hospital
Albuquerque
University of New Mexico Cancer Center
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Rio Rancho
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
OptumCare Cancer Care at Seven Hills
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
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Las Vegas
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Las Vegas
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Las Vegas
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GenesisCare USA - Las Vegas
Las Vegas
OptumCare Cancer Care at Charleston
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Las Vegas
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Las Vegas
Radiation Oncology Centers of Nevada Central
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Radiation Oncology Associates
Reno
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Montefiore Medical Center - Moses Campus
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Montefiore Medical Center-Weiler Hospital
Bronx
Sands Cancer Center
Canandaigua
Noyes Memorial Hospital/Myers Cancer Center
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Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
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Garnet Health Medical Center
Middletown
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
NYP/Weill Cornell Medical Center
New York
University of Rochester
Rochester
State University of New York Upstate Medical University
Syracuse
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Saint Elizabeth Boardman Hospital
Boardman
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
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Oncology Hematology Care Inc-Kenwood
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Cleveland Clinic Cancer Center/Fairview Hospital
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Cleveland Clinic Foundation
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MetroHealth Medical Center
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Dayton Physician LLC - Englewood
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
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Dayton Physicians LLC-Wayne
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Wayne Hospital
Greenville
Cleveland Clinic Cancer Center Independence
Independence
Greater Dayton Cancer Center
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Kettering
Cleveland Clinic Cancer Center Mansfield
Mansfield
Hillcrest Hospital Cancer Center
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North Coast Cancer Care
Sandusky
Springfield Regional Cancer Center
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Springfield Regional Medical Center
Springfield
Cleveland Clinic Cancer Center Strongsville
Strongsville
ProMedica Flower Hospital
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Dayton Physicians LLC - Troy
Troy
Upper Valley Medical Center
Troy
Saint Joseph Warren Hospital
Warren
South Pointe Hospital
Warrensville Heights
University of Cincinnati Cancer Center-West Chester
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Cleveland Clinic Wooster Family Health and Surgery Center
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Saint Elizabeth Youngstown Hospital
Youngstown
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Mercy Hospital Oklahoma City
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Providence Newberg Medical Center
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Providence Portland Medical Center
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Providence Saint Vincent Medical Center
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Lehigh Valley Hospital-Cedar Crest
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Saint Luke's Cancer Center - Allentown
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UPMC Altoona
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UPMC-Heritage Valley Health System Beaver
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Lehigh Valley Hospital - Muhlenberg
Bethlehem
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UPMC Hillman Cancer Center at Butler Health System
Butler
UPMC Camp Hill
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Carlisle Regional Cancer Center
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Christiana Care Health System-Concord Health Center
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Geisinger Medical Center
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Pocono Medical Center
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Saint Luke's Hospital-Anderson Campus
Easton
UPMC Hillman Cancer Center Erie
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UPMC Cancer Center at UPMC Horizon
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UPMC Cancer Centers - Arnold Palmer Pavilion
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UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
Penn State Milton S Hershey Medical Center
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IRMC Cancer Center
Indiana
Jefferson Hospital
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UPMC-Johnstown/John P. Murtha Regional Cancer Center
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Geisinger Medical Oncology-Lewisburg
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UPMC Cancer Center at UPMC McKeesport
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Monroeville
UPMC Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center in Coraopolis
Moon
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon
Allegheny Valley Hospital
Natrona Heights
UPMC Hillman Cancer Center - New Castle
New Castle
University of Pennsylvania/Abramson Cancer Center
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Magee Womens Hospital
Pittsburgh
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
West Penn Hospital
Pittsburgh
Pottstown Hospital
Pottstown
UPMC Cancer Center at UPMC Northwest
Seneca
UPMC Cancer Center-Uniontown
Uniontown
UPMC Uniontown Hospital Radiation Oncology
Uniontown
UPMC Cancer Center-Washington
Washington
UPMC Washington Hospital Radiation Oncology
Washington
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin
Reading Hospital
West Reading
Wexford Health and Wellness Pavilion
Wexford
UPMC Memorial
York
Rhode Island
Rhode Island Hospital at East Greenwich
East Greenwich
Newport Hospital
Newport
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
South Dakota
Avera Cancer Institute
Sioux Falls
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Saint Joseph Regional Cancer Center
Bryan
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
Richardson
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
University of Utah Sugarhouse Health Center
Salt Lake City
Virginia
University of Virginia Cancer Center
Charlottesville
Virginia Cancer Institute
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
VCU Community Memorial Health Center
South Hill
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Dartmouth Cancer Center - North
Saint Johnsbury
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
Overlake Medical Center
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Swedish Cancer Institute-Issaquah
Issaquah
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
Valley Medical Center
Renton
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Saint Michael Cancer Center
Silverdale
Northwest Medical Specialties PLLC
Tacoma
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Wisconsin
ThedaCare Regional Cancer Center
Appleton
Duluth Clinic Ashland
Ashland
Northwest Wisconsin Cancer Center
Ashland
Aurora Cancer Care-Southern Lakes VLCC
Burlington
HSHS Sacred Heart Hospital
Eau Claire
Marshfield Medical Center-EC Cancer Center
Eau Claire
Aurora Health Center-Fond du Lac
Fond Du Lac
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Bellin Memorial Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Essentia Health-Hayward Clinic
Hayward
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek
Aurora Cancer Care-Kenosha South
Kenosha
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Essentia Health-Spooner Clinic
Spooner
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Essentia Health Saint Mary's Hospital - Superior
Superior
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
West Virginia
United Hospital Center
Bridgeport
West Virginia University Charleston Division
Charleston
West Virginia University Healthcare
Morgantown
Camden Clark Medical Center
Parkersburg
Time Frame
Start Date: 2019-05-03
Completion Date: 2026-01-31
Participants
Target number of participants: 278
Treatments
Experimental: Arm A (carboplatin, paclitaxel, radiation therapy)
Patients receive carboplatin IV and paclitaxel IV once weekly and undergo radiation therapy QD (Monday-Friday) beginning on day 1 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.
Experimental: Arm B (carboplatin, paclitaxel, radiation therapy, nivolumab)
Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.
Experimental: Arm C (nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.
Experimental: Arm D (nivolumab, ipilimumab)
Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1 and 4 and day 15 of cycles 2 and 5. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov