Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma
- Conditions
- Malignant Melanoma
- Registration Number
- NCT02186249
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Men and women 18 years and older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
- Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
- Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration
- Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
- Life expectancy < 6 weeks
- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
Medstar Health Research Institute
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
UF Health Cancer Center at Orlando Health
🇺🇸Longwood, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Greenville Health System
🇺🇸Easley, South Carolina, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Chuq Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Grand River Hospital
🇨🇦Kitchener, Ontario, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Oncology Specialists, SC
🇺🇸Niles, Illinois, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Angeles Clinic and Research Institute
🇺🇸Santa Monica, California, United States
1325 East Church Street
🇺🇸Santa Monica, California, United States
Georgetown-Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Rocky Mountain Cancer Centers
🇺🇸Littleton, Colorado, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
514 North Prospect Ave
🇺🇸Redondo Beach, California, United States
4500 San Pablo Road South
🇺🇸Jacksonville, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Tulsa Cancer Institute PLLC
🇺🇸Tulsa, Oklahoma, United States
Shenandoah Oncology Association
🇺🇸Winchester, Virginia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Texas Oncology
🇺🇸Paris, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Smilow Cancer Hospital at Yale University Cancer Center
🇺🇸New Haven, Connecticut, United States
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Local Institution
🇺🇸Louisville, Kentucky, United States
Northwest Cancer Specialists PC
🇺🇸Portland, Oregon, United States
Tennessee Oncology PLLC
🇺🇸Nashville, Tennessee, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Center For Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
6501 Truxtun Avenue
🇺🇸Bakersfield, California, United States
100 UCLA Medical Plaza
🇺🇸Los Angeles, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
600 Celebrate Life Parkway
🇺🇸Newnan, Georgia, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
🇺🇸Roanoke, Virginia, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
St Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States