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

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ClinicalTrials.gov Identifier: NCT02142218
Expanded Access Status : No longer available
First Posted : May 20, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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

Study Type : 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)
Study Start Date : June 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142218


  Show 79 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02142218     History of Changes
Other Study ID Numbers: CA209-168
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs