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Clinical Trial 19686

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT01968109

Phase: Phase I/II
Prinicipal Investigator:

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Study Title

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors


The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.


Part A and B: The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and MTD of BMS-986016 administered alone and in combination with nivolumab in subjects with advanced solid tumors. Part A1:The primary objective of BMS-986016 monotherapy cohort expansion is to gather additional safety,tolerability, and preliminary efficacy information of BMS-986016 monotherapy.




BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); BMS-986213 (); Nivolumab ()

Inclusion Criteria

  • Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
  • ECOG performance status between 0 and 2
  • At least 1 lesion with measurable disease at baseline
  • Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
  • Additional critieria may apply

  • Exclusion Criteria

  • Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
  • Autoimmune disease
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  • Uncontrolled CNS metastases
  • Additional criteria may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.