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Brief Title Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Official Title A Phase I/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
Principal Investigator Gajewski, Thomas
Brief Summary To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.
Gender Both
Ages 18 Years
Enrollment 540
Accepts Healthy Volunteers No
Lead Sponsor Bristol-Myers SquibbIndustry
Collaborator Ono Pharmaceutical Co. LtdIndustry
Study Design Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Neoplasms by Site
Detail for Health Professional (on
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