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

Expanded access is currently available for this treatment.
Verified May 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02142218
First received: May 16, 2014
Last updated: May 13, 2016
Last verified: May 2016
  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:

Study Start Date: June 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
  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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 82 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: May 13, 2016
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
Nivolumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 24, 2016