CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,482 enrolled
Drug / intervention
Relatlimab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01968109
NCT01968109Phase 2Completed

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

Bristol-Myers Squibb·interventional·Posted Oct 23, 2013·Updated Apr 6, 2026

In Brief

A Phase 2 clinical trial evaluating Relatlimab, Nivolumab, and 1 other intervention for Neoplasms by Site. Completed, enrolled 1,482 participants across 54 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 23, 2013
Enrollment StartNov 5, 2013
Primary CompletionMay 22, 2024
Study CompletionFeb 3, 2025
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 12.7 years ago

Interventions

Relatlimabbiological

Nivolumabbiological

BMS-986213biological

Relatlimab + Nivolumab