Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Status: Active_not_recruiting
Location: See all (201) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

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

• 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

• Absolute neutrophil count (ANC) \>= 1,500/ul (within 14 days prior to registration)

• Platelets \>= 100,000/ul (within 14 days prior to registration)

• Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to registration)

• Bilirubin =\< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =\< 3.0 mg/dL is acceptable (within 14 days prior to registration)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 14 days prior to registration)

• Albumin \>= 2.8 g/dL (within 14 days prior to registration)

• Adequate thyroid function within 28 days prior to registration defined as serum thyroid-stimulating hormone (TSH) in normal range

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• Platinum-free interval (PFI) - patients must have progressed \< 12 months after completion of their last platinum-based chemotherapy; the date (platinum free interval) should be calculated from the last administered dose of platinum therapy to documentation of progression

• Adequate oxygen saturation via pulse oximeter within 28 days prior to registration (i.e., patient can NOT have CTCAE hypoxia grade 2 or greater)

• Left ventricular ejection fraction (LVEF) \>= 50% (measured within 28 days of study entry)

Locations
United States
California
Sutter Auburn Faith Hospital
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Sutter Davis Hospital
Davis
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
Palo Alto Medical Foundation Health Care
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Sutter Medical Center Sacramento
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
UCSF Medical Center-Mission Bay
San Francisco
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
AdventHealth Porter
Denver
Colorado Blood Cancer Institute
Denver
Denver Health Medical Center
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
Saint Joseph Hospital - Cancer Centers of Colorado
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Mountain Blue Cancer Care Center - Swedish
Englewood
Swedish Medical Center
Englewood
Poudre Valley Hospital
Fort Collins
Mountain Blue Cancer Care Center
Golden
National Jewish Health-Western Hematology Oncology
Golden
Banner North Colorado Medical Center
Greeley
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
Banner McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
Rocky Mountain Cancer Centers-Thornton
Thornton
Intermountain Health Lutheran Hospital
Wheat Ridge
Connecticut
Yale University
New Haven
Washington, D.c.
Sibley Memorial Hospital
Washington
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Helen F Graham Cancer Center
Newark
Georgia
Emory Decatur Hospital
Decatur
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Iowa
Mercy Cancer Center-West Lakes
Clive
Mission Cancer and Blood - West Des Moines
Clive
Alegent Health Mercy Hospital
Council Bluffs
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Mercy Medical Center-West Lakes
West Des Moines
Illinois
Rush - Copley Medical Center
Aurora
University of Chicago Comprehensive Cancer Center
Chicago
Carle at The Riverfront
Danville
Carle Physician Group-Effingham
Effingham
Northwestern Medicine Cancer Center Delnor
Geneva
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale
Carle Physician Group-Mattoon/Charleston
Mattoon
SSM Health Good Samaritan
Mount Vernon
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Rush-Copley Healthcare Center
Yorkville
Indiana
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Franciscan Saint Anthony Health-Michigan City
Michigan City
Woodland Cancer Care Center
Michigan City
Kentucky
Flaget Memorial Hospital
Bardstown
Commonwealth Cancer Center-Corbin
Corbin
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
Jewish Hospital
Louisville
Saints Mary and Elizabeth Hospital
Louisville
UofL Health Medical Center Northeast
Louisville
Jewish Hospital Medical Center South
Shepherdsville
Massachusetts
Tufts Medical Center
Boston
Maryland
Greater Baltimore Medical Center
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Sinai Hospital of Baltimore
Baltimore
Northwest Hospital Center
Randallstown
Maine
Maine Medical Center- Scarborough Campus
Scarborough
Michigan
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Medical Center-Fairlane
Dearborn
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
West Michigan Cancer Center
Kalamazoo
Henry Ford Medical Center-Columbus
Novi
Corewell Health Reed City Hospital
Reed City
Munson Medical Center
Traverse City
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Missouri
Central Care Cancer Center - Bolivar
Bolivar
Cox Cancer Center Branson
Branson
Mercy Hospital Joplin
Joplin
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Mercy Hospital Saint Louis
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Washington University School of Medicine
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
North Carolina
Randolph Hospital
Asheboro
Cone Health Cancer Center at Alamance Regional
Burlington
Cone Health Cancer Center
Greensboro
Margaret R Pardee Memorial Hospital
Hendersonville
Cone Heath Cancer Center at Mebane
Mebane
Annie Penn Memorial Hospital
Reidsville
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Trinity Cancer Care Center
Minot
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
CHI Health Good Samaritan
Kearney
Nebraska Medicine Heartland Hematology Oncology
Kearney
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Hematology and Oncology Consultants PC
Omaha
Nebraska Methodist Hospital
Omaha
Midlands Community Hospital
Papillion
New Hampshire
Wentworth-Douglass Hospital
Dover
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Memorial Sloan Kettering Monmouth
Middletown
Inspira Medical Center Vineland
Vineland
Nevada
Women's Cancer Center of Nevada
Las Vegas
New York
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow
Memorial Sloan Kettering Nassau
Uniondale
Ohio
Cleveland Clinic Akron General
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights
University Hospitals Sharon Health Center
Wadsworth
UHHS-Westlake Medical Center
Westlake
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Pennsylvania
Jefferson Abington Hospital
Abington
Lehigh Valley Hospital-Cedar Crest
Allentown
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem
University of Pennsylvania/Abramson Cancer Center
Philadelphia
Chester County Hospital
West Chester
Rhode Island
Women and Infants Hospital
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Prisma Health Cancer Institute - Easley
Easley
Gibbs Cancer Center-Gaffney
Gaffney
Greenville Health System Cancer Institute-Andrews
Greenville
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Saint Francis Cancer Center
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Spartanburg Medical Center
Spartanburg
MGC Hematology Oncology-Union
Union
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Memorial Hospital
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson
Memorial GYN Plus
Ooltewah
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Virginia
Inova Fairfax Hospital
Falls Church
Carilion Clinic Gynecological Oncology
Roanoke
Washington
Highline Medical Center-Main Campus
Burien
Saint Elizabeth Hospital
Enumclaw
Saint Francis Hospital
Federal Way
Kadlec Clinic Hematology and Oncology
Kennewick
Saint Clare Hospital
Lakewood
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
FHCC South Lake Union
Seattle
Saint Michael Cancer Center
Silverdale
Franciscan Research Center-Northwest Medical Plaza
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Wisconsin
Medical College of Wisconsin
Milwaukee
West Virginia
Monongalia Hospital
Morgantown
Time Frame
Start Date: 2015-06-29
Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Group I (nivolumab)
INDUCTION: 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.
Experimental: Group II (nivolumab, ipilimumab)
INDUCTION: 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.
Sponsors
Leads: National Cancer Institute (NCI)
Collaborators: NRG Oncology

This content was sourced from clinicaltrials.gov

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