Expanded Access Program With Nivolumab to Treat Melanoma (Checkmate 168)

Expanded access is currently available for this treatment.
Verified May 2015 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02142218
First received: May 16, 2014
Last updated: June 22, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Stage III (Unresectable) or Stage IV Advanced Melanoma
Drug: Nivolumab

Study Type: Expanded Access     What is Expanded Access?
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02142218

Contacts
Contact: Please contact: Clinical.Trials@bms.com

Locations
Brazil
Local Institution
Salvador, Bahia, Brazil, 41950-610
Contact: Site 0016         
Local Institution
Fortaleza, Ceará, Brazil, 60130-241
Contact: Site 0069         
Local Institution
Curitiba, Paraná, Brazil, 80530-010
Contact: Site 0022         
Local Institution
Londrina, Paraná, Brazil, 86015-520
Contact: Site 0057         
Local Institution
Ijuí, Rio Grande do Sul, Brazil, 98700-000
Contact: Site 0054         
Local Institution
Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
Contact: Site 0052         
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
Contact: Site 0018         
Local Institution
Florianópolis, Santa Catarina, Brazil, 88034-000
Contact: Site 0055         
Local Institution
Ribeirão Preto, São Paulo, Brazil, 14025-270
Contact: Site 0053         
Local Institution
Rio De Janeiro, Brazil, 20220-410
Contact: Site 0020         
Local Institution
São José Do Rio Preto, Brazil, 15090-000
Contact: Site 0051         
Local Institution
São Paulo, Brazil, 01509-900
Contact: Site 0019         
Local Institution
São Paulo, Brazil, 01323-001
Contact: Site 0017         
Local Institution
São Paulo, Brazil, 01308-050
Contact: Site 0015         
Local institution
São Paulo, Brazil, 03102-002
Contact: Site 0070         
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4
Contact: Site 0061         
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0056         
Canada, British Columbia
Local Institution
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Site 0037         
Local Institution
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0063         
Local Institution
Victoria, British Columbia, Canada, V8R 6V5
Contact: Site 0064         
Canada, Manitoba
Local Institution
Winnepeg, Manitoba, Canada, R2H 2A6
Contact: Site 0049         
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Site 0034         
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 0065         
Local Institution
London, Ontario, Canada, N6A 4L6
Contact: Site 0066         
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0062         
Local Institution
Toronto, Ontario, Canada, M4N 3M5
Contact: Site 0067         
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0060         
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0029         
Local Institution
Québec, Quebec, Canada, G1R 2J6
Contact: Site 0033         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02142218     History of Changes
Other Study ID Numbers: CA209-168
Study First Received: May 16, 2014
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Institutional Review Board
Canada: Health Canada
Brazil: Ethics Committee
Brazil: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 02, 2015