Clinical trial NCT02186249: Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma
Official title: Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Malignant Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-07-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Bakersfield
country: United States
facility: 6501 Truxtun Avenue
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: 100 UCLA Medical Plaza
state: California
city: Redondo Beach
country: United States
facility: 514 North Prospect Ave
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Angeles Clinic and Research Institute
state: California
city: Santa Monica
country: United States
facility: 1325 East Church Street
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale University Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown-Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: 4500 San Pablo Road South
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Longwood
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Newnan
country: United States
facility: 600 Celebrate Life Parkway
state: Georgia
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Niles
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Baltimore
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Center For Cancer and Blood Disorders
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Tulsa
country: United States
facility: Tulsa Cancer Institute PLLC
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cancer Specialists PC
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: St Luke's Hospital
state: Pennsylvania
city: Easley
country: United States
facility: Greenville Health System
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Midland
country: United States
facility: Texas Oncology
state: Texas
city: Paris
country: United States
facility: Texas Oncology
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology Association
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Quebec
country: Canada
facility: Chuq Centre Hospitalier Universitaire de Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.