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Clinical Trial 19686

Cancer Type:
Interventions:

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Nikhil Khushalani

Call 813-745-6100
or 1-800-679-0775
Overview

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

Summary

Objective

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.

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