An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01968109
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Neoplasms by Site

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relatlimab — BIOLOGICAL
  • Nivolumab — BIOLOGICAL
  • BMS-986213 — BIOLOGICAL
    Relatlimab + Nivolumab

Study Details

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. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Key Dates

Start date
Nov 5, 2013
Status verified
Mar 2026
Primary completion
May 22, 2024
Completion
Feb 3, 2025

Study Design

Enrollment
1,482 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relatlimab
    Relatlimab (BMS-986016) specified dose on specified days
  • Experimental: Relatlimab + Nivolumab
    Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days
  • Experimental: BMS-986213
    Relatlimab (BMS-986016) + Nivolumab (BMS-936558)

Primary Outcome Measure

Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities [ Time Frame: From first dose and within 135 days after last dose of study therapy (Up to approximately 82 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Local Institution - 0043La JollaCalifornia92093-0698-
Local Institution - 0053AuroraColorado80045-
Local Institution - 0058TampaFlorida33612-
Local Institution - 0003ChicagoIllinois60637-
Local Institution - 0048NilesIllinois60714-
Local Institution - 0004BaltimoreMaryland21287-
Local Institution - 0001BostonMassachusetts02215-
Local Institution - 0011DetroitMichigan48201-
Local Institution - 0051RochesterMinnesota55905-0001-
Local Institution - 0044St LouisMissouri63110-
Local Institution - 0005New YorkNew York10065-
Local Institution - 0002PortlandOregon97213-
Local Institution - 0047AllentownPennsylvania18103-
Local Institution - 0010PittsburghPennsylvania15232-1305-
Local Institution - 0057DallasTexas75246-
Local Institution - 0045HoustonTexas77030-
Local Institution - 0008SeattleWashington98109-

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By research site
Local Institution - 0043· La Jolla, CALocal Institution - 0053· Aurora, COLocal Institution - 0058· Tampa, FLLocal Institution - 0003· Chicago, ILLocal Institution - 0048· Niles, ILLocal Institution - 0004· Baltimore, MD

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