Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma
NCT ID: NCT02186249
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Nivolumab
Ipilimumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
6501 Truxtun Avenue
Bakersfield, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
100 UCLA Medical Plaza
Los Angeles, California, United States
514 North Prospect Ave
Redondo Beach, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Angeles Clinic and Research Institute
Santa Monica, California, United States
1325 East Church Street
Santa Monica, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Smilow Cancer Hospital at Yale University Cancer Center
New Haven, Connecticut, United States
Georgetown-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Memorial Regional Hospital
Hollywood, Florida, United States
4500 San Pablo Road South
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
UF Health Cancer Center at Orlando Health
Longwood, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
600 Celebrate Life Parkway
Newnan, Georgia, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States
Oncology Specialists, SC
Niles, Illinois, United States
Local Institution
Louisville, Kentucky, United States
Medstar Health Research Institute
Baltimore, Maryland, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Atlantic Health System
Morristown, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Tulsa Cancer Institute PLLC
Tulsa, Oklahoma, United States
Northwest Cancer Specialists PC
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
St Luke's Hospital
Bethlehem, Pennsylvania, United States
Greenville Health System
Easley, South Carolina, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Texas Oncology
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology
Midland, Texas, United States
Texas Oncology
Paris, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke, Virginia, United States
Shenandoah Oncology Association
Winchester, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Grand River Hospital
Kitchener, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Chuq Centre Hospitalier Universitaire de Quebec
Québec, , Canada
Countries
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References
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Hodi FS, Chapman PB, Sznol M, Lao CD, Gonzalez R, Smylie M, Daniels GA, Thompson JA, Kudchadkar R, Sharfman W, Atkins M, Spigel DR, Pavlick A, Monzon J, Kim KB, Ernst S, Khushalani NI, van Dijck W, Lobo M, Hogg D. Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218). Melanoma Res. 2021 Feb 1;31(1):67-75. doi: 10.1097/CMR.0000000000000708.
Related Links
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BMS clinical trial educational resource
EAP Investigator Requests
Other Identifiers
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CA209-218
Identifier Type: -
Identifier Source: org_study_id
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