Expanded Access Program With Nivolumab to Treat Melanoma

NCT02142218 | Unknown

• 1 other identifier: CA209-168
• Study Type: expanded_access
• Target: N/A
• Locations: 6 countries
• Sites: 80

Brief Summary

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

Conditions

Stage III (Unresectable) or Stage IV Advanced Melanoma

Interventions

Nivolumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (80)

Local Institution

Mobile, Alabama, 36604, United States

Location

Southern Cancer Center Pc

Mobile, Alabama, 36608, United States

Location

Local Institution

Encinitas, California, 92024, United States

Location

Local Institution

Washington D.C., District of Columbia, 20057, United States

Location

Lynn Cancer Institute At Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Cancer Specialists Of North Florida

Jacksonville, Florida, 32256, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Summit Cancer Care

Savannah, Georgia, 31404, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Oncology Hematology Associates Of Sw In

Newburgh, Indiana, 47630, United States

Location

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Lutherville, Maryland, 21093, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers Of Nevada

Las Vegas, Nevada, 89148, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Icahn School Of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Mid Ohio Oncology/Hematology, Inc,Dba

Columbus, Ohio, 43219, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

St. Luke'S Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

The Jones Clinic, Pc

Germantown, Tennessee, 38138, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1019, Argentina

Location

Local Institution

Buenos Aires, Buenos Aires, 1431, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1280, Argentina

Location

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181, Argentina

Location

Local Institution

Córdoba, Córdoba Province, 5000, Argentina

Location

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Rosario, Santa Fe Province, S2000DSK, Argentina

Location

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

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San Miguel de Tucumán, Tucumán Province, CPT4000IAK, Argentina

Location

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Caba, 1426, Argentina

Location

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Fortaleza, Ceará, 60130, Brazil

Location

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Salvador, Estado de Bahia, 41950, Brazil

Location

Local Institution

Brasília, Federal District, 70200, Brazil

Location

Local Institution

Belo Horizonte, Minas Gerais, 30150, Brazil

Location

Local Institution

Belo Horizonte, Minas Gerais, 30380, Brazil

Location

Local Institution

Jd. Petropolis-Londrina, Paraná, 86015, Brazil

Location

Local Institution

Ijuí, Rio Grande do Sul, 98700, Brazil

Location

Local Institution

Passo Fundo, Rio Grande do Sul, 99010, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90840, Brazil

Location

Local Institution

Florianópolis, Santa Catarina, 88015, Brazil

Location

Local Institution

Itajaí, Santa Catarina, 88301, Brazil

Location

Local Institution

Barretos, São Paulo, 14780, Brazil

Location

Local Institution

Jaú, São Paulo, 17210, Brazil

Location

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Ribeirão Preto, São Paulo, 14025, Brazil

Location

Local Institution

Santo André, São Paulo, 09060, Brazil

Location

Local Institution

São José do Rio Preto, São Paulo, 15090, Brazil

Location

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São Paulo, São Paulo, 01308, Brazil

Location

Local Institution

São Paulo, São Paulo, 01323, Brazil

Location

Local Institution

São Paulo, São Paulo, 01509, Brazil

Location

Local Institution

São Paulo, São Paulo, 03102, Brazil

Location

Local Institution

São Paulo, São Paulo, 04538, Brazil

Location

Local Institution

São Paulo, São Paulo, 05651, Brazil

Location

Local Institution

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Kelowna, British Columbia, V1Y 5L3, Canada

Location

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North Vancouver, British Columbia, V7L 2L7, Canada

Location

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Vancouver, British Columbia, V5Z 4E6, Canada

Location

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Winnipeg, Manitoba, R3E 0V9, Canada

Location

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Moncton, New Brunswick, E1C 8X3, Canada

Location

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

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Halifax, Nova Scotia, B3H 1V7, Canada

Location

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Hamilton, Ontario, L8V 5C2, Canada

Location

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London, Ontario, N6A 4L6, Canada

Location

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Ottawa, Ontario, K1H 8L6, Canada

Location

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Toronto, Ontario, M4N 3M5, Canada

Location

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Toronto, Ontario, M5G 2M9, Canada

Location

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Montreal, Quebec, H3T 1E2, Canada

Location

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Québec, Quebec, G1R 2J6, Canada

Location

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Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

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Bogotá, 110221, Colombia

Location

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Bogotá, Colombia

Location

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Cali, Colombia

Location

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Medellín, MEDELLIN, Colombia

Location

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Medellín, Colombia

Location

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Lima, Lima Province, 34, Peru

Location

Local Institution

Lima, Lima Province, Peru

Location

Local Institution

Lima, 027, Peru

Location

Local Institution

Lima, Peru

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

PE (4); CA (17); CO (5); BR (22); AR (9); US (23)