Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
4 other identifiers
interventional
100
1 country
201
Brief Summary
This randomized phase II trial studies how well nivolumab works with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has not responded after prior treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2015
Longer than P75 for phase_2
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Start
First participant enrolled
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2018
CompletedResults Posted
Study results publicly available
September 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2025
CompletedAugust 29, 2025
August 1, 2025
3.1 years
July 14, 2015
May 27, 2020
August 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Tumor Response
Complete and Partial Tumor Response by modified irRECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Within 6 months of study entry
Secondary Outcomes (3)
Progression-free Survival (PFS)
The duration of time from study entry to time of progression or death, whichever occurs first, an average of 3.9 months.
Duration of Overall Survival (OS)
The duration of time from study entry to time of death or the date of last contact, assessed up to 5 years
Incidence of Adverse Events Grade 3 and Above
Up to 30 days after treatment ends
Other Outcomes (3)
Natural Anti-tumor Immunity in Tumor Infiltrating Lymphocytes and Tumor Cells
Baseline
Markers of "Immunogenicity"
Baseline
Changes in Biomarkers
Baseline to after the first 8 weeks of therapy
Study Arms (2)
Group I (nivolumab)
ACTIVE COMPARATORINDUCTION: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable toxicity.
Group II (nivolumab, ipilimumab)
EXPERIMENTALINDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer with documented disease progression (disease not amendable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report; NOTE: patients with mucinous histology are NOT eligible; patients with carcinosarcoma histology are NOT eligible
- All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
- Patients must have at least one "target" lesion to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Appropriate for study entry based on the following diagnostic workup:
- History/physical examination within 28 days prior to registration
- Imaging of target lesion(s) within 28 days prior to registration
- Further protocol-specific assessments:
- Recovery from effects of recent surgery, radiotherapy or chemotherapy
- Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
- Any prior radiation therapy must be completed at least 4 weeks prior to registration
- At least 4 weeks must have elapsed since major surgery
- Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer; they must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment; patients are allowed to have received, but are not required to have received, one to two cytotoxic regimens for management of recurrent or persistent disease; (for the purposes of this study poly adenosine diphosphate \[ADP\] ribose polymerase \[PARP\] inhibitors given for recurrent or progressive disease will be considered cytotoxic; PARP inhibitors given as maintenance therapy in continuation with management of primary disease will not be considered as a separate cytotoxic regimen); if two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent
- Performance status of 0, 1 or 2 within 28 days prior to registration
- +11 more criteria
You may not qualify if:
- Patients who have had prior therapy with nivolumab or with an anti-programmed cell death (PD)-1, anti-PD-ligand (L)1, anti-PD-L2, anti-cytotoxic T-lymphocyte-antigen (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways
- History of severe hypersensitivity reaction to any monoclonal antibody
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, and the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued; patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure and unstable angina pectoris
- Patients with history of organ transplant
- Patients who are pregnant or nursing; women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IV/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab or nivolumab + ipilimumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception; women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL; if, following initiation of the investigational product(s), it is subsequently discovered that a study subject is pregnant or may have been pregnant at the time of investigational product exposure, including during at least 6 half-lives after product administration, the investigational product will be permanently discontinued in an appropriate manner (e.g., dose tapering if necessary for subject safety); the investigator must report this event and any outcomes by amendment through Cancer Therapy Evaluation Program (CTEP)-Adverse Event Reporting System (AERS); protocol-required procedures for study discontinuation and follow-up must be performed on the subject unless contraindicated by pregnancy (e.g., X-ray studies); other appropriate pregnancy follow-up procedures should be considered if indicated; in addition, the investigator must report and follow-up on information regarding the course of the pregnancy, including perinatal and neonatal outcome; infants should be followed for a minimum of 8 weeks
- History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (cerebrovascular accident \[CVA\], stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment
- In order for patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen, have cluster of differentiation (CD)4 counts \> 350, with no detectable viral load on quantitative polymerase chain reaction (PCR)
- Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
- 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, should 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 diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient 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 should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
- Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
- Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
- Any of the following within 2 months of registration: active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption syndrome; any of the following within 6 months of registration: intra-abdominal abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition, gastrointestinal perforation; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration
- No planned concomitant, non-protocol directed anti-cancer therapy
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (201)
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Sutter Davis Hospital
Davis, California, 95616, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, 95065, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Banner McKee Medical Center
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Yale University
New Haven, Connecticut, 06520, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Emory Decatur Hospital
Decatur, Georgia, 30033, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Northwest Hospital Center
Randallstown, Maryland, 21133, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
Fred and Pamela Buffett Cancer Center - Kearney
Kearney, Nebraska, 68845, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Hematology and Oncology Consultants PC
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, 27302, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio, 44124, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, 44281, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343, United States
Memorial GYN Plus
Ooltewah, Tennessee, 37363, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
Monongalia Hospital
Morgantown, West Virginia, 26505, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Michael Sill, PhD.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitry Zamarin
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2015
First Posted
July 15, 2015
Study Start
August 10, 2015
Primary Completion
September 5, 2018
Study Completion
July 26, 2025
Last Updated
August 29, 2025
Results First Posted
September 11, 2020
Record last verified: 2025-08