Expanded Access Program With Nivolumab to Treat Melanoma

NCT ID: NCT02142218

Last Updated: 2016-09-29

Study Results

Results pending

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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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2014-06-30

Study Completion Date

2018-05-31

Brief Summary

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

Detailed Description

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Conditions

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Stage III (Unresectable) or Stage IV Advanced Melanoma

Interventions

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Nivolumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Mobile, Alabama, United States

Site Status

Southern Cancer Center Pc

Mobile, Alabama, United States

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Local Institution

Encinitas, California, United States

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Local Institution

Washington D.C., District of Columbia, United States

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Lynn Cancer Institute At Boca Raton Regional Hospital

Boca Raton, Florida, United States

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Cancer Specialists Of North Florida

Jacksonville, Florida, United States

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Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

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Florida Hospital

Orlando, Florida, United States

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Winship Cancer Institute

Atlanta, Georgia, United States

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Summit Cancer Care

Savannah, Georgia, United States

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Oncology Specialists, S.C.

Park Ridge, Illinois, United States

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Oncology Hematology Associates Of Sw In

Newburgh, Indiana, United States

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Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Lutherville, Maryland, United States

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Nebraska Cancer Specialists

Omaha, Nebraska, United States

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Comprehensive Cancer Centers Of Nevada

Las Vegas, Nevada, United States

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North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, United States

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Icahn School Of Medicine At Mount Sinai

New York, New York, United States

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Mid Ohio Oncology/Hematology, Inc,Dba

Columbus, Ohio, United States

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Lehigh Valley Health Network

Allentown, Pennsylvania, United States

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St. Luke'S Hospital

Bethlehem, Pennsylvania, United States

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The Jones Clinic, Pc

Germantown, Tennessee, United States

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Tennessee Oncology, PLLC

Nashville, Tennessee, United States

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Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

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Local Institution

Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Caba, , Argentina

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Fortaleza, Ceará, Brazil

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Salvador, Estado de Bahia, Brazil

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Brasília, Federal District, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Jd. Petropolis-Londrina, Paraná, Brazil

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Ijuí, Rio Grande do Sul, Brazil

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Passo Fundo, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Florianópolis, Santa Catarina, Brazil

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Itajaí, Santa Catarina, Brazil

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Barretos, São Paulo, Brazil

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Jaú, São Paulo, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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North Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Bogotá, , Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Medellín, , Colombia

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Medellín, , Colombia

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, , Peru

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Lima, , Peru

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Countries

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United States Argentina Brazil Canada Colombia Peru

Related Links

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Other Identifiers

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CA209-168

Identifier Type: -

Identifier Source: org_study_id

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