Clinical trial NCT02142218: Expanded Access Program With Nivolumab to Treat Melanoma
Official title: Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti CTLA-4 Monoclonal Antibody (Checkmate 168: CHECKpoint Pathway for nivoluMAb Clinical Trial Evaluation 168)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Stage III (Unresectable) or Stage IV Advanced Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-05-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.


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

Inclusion Criteria:

* ECOG Performance Status of 0-1
* Histologically confirmed malignant melanoma
* Progressed on or after treatment with an anti-CTLA4

Exclusion Criteria:

* Active brain metastases
* Life Expectancy \<6 weeks
* Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy
* Subjects with autoimmune disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center Pc
state: Alabama
city: Encinitas
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute At Boca Raton Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists Of North Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Newburgh
country: United States
facility: Oncology Hematology Associates Of Sw In
state: Indiana
city: Lutherville
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers Of Nevada
state: Nevada
city: East Setauket
country: United States
facility: North Shore Hematology/Oncology Associates, P.C.
state: New York
city: New York
country: United States
facility: Icahn School Of Medicine At Mount Sinai
state: New York
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology, Inc,Dba
state: Ohio
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: Germantown
country: United States
facility: The Jones Clinic, Pc
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Brasilia
country: Brazil
facility: Local Institution
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Jd. Petropolis-Londrina
country: Brazil
facility: Local Institution
state: Parana
city: Ijui
country: Brazil
facility: Local Institution
state: Rio Grande do Sul
city: Passo Fundo
country: Brazil
facility: Local Institution
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Itajai
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Kelowna
country: Canada
facility: Local Institution
state: British Columbia
city: North Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: St. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution
city: Bogota
country: Colombia
facility: Local Institution
city: Bogota
country: Colombia
facility: Local Institution
city: Cali
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: