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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02142218
Other study ID # CA209-168
Secondary ID
Status No longer available
Phase N/A
First received May 16, 2014
Last updated September 28, 2016
Start date June 2014
Est. completion date May 2018

Study information

Verified date September 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Institutional Review BoardCanada: Health CanadaBrazil: Ethics CommitteeBrazil: Ministry of Health
Study type Expanded Access

Clinical Trial Summary

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


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms

  • Melanoma
  • Stage III (Unresectable) or Stage IV Advanced Melanoma

Intervention

Drug:
Nivolumab


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Colombia,  Peru,