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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01968109

Public ClinicalTrials.gov record NCT01968109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 9:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01968109
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
1,482 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2013 (Actual)
Primary completion
May 22, 2024 (Actual)
Completion
Feb 3, 2025 (Actual)
Last update posted
Apr 6, 2026

2013 – 2025

United States locations

U.S. sites
17
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
Local Institution - 0043 La Jolla California 92093-0698 —
Local Institution - 0053 Aurora Colorado 80045 —
Local Institution - 0058 Tampa Florida 33612 —
Local Institution - 0003 Chicago Illinois 60637 —
Local Institution - 0048 Niles Illinois 60714 —
Local Institution - 0004 Baltimore Maryland 21287 —
Local Institution - 0001 Boston Massachusetts 02215 —
Local Institution - 0011 Detroit Michigan 48201 —
Local Institution - 0051 Rochester Minnesota 55905-0001 —
Local Institution - 0044 St Louis Missouri 63110 —
Local Institution - 0005 New York New York 10065 —
Local Institution - 0002 Portland Oregon 97213 —
Local Institution - 0047 Allentown Pennsylvania 18103 —
Local Institution - 0010 Pittsburgh Pennsylvania 15232-1305 —
Local Institution - 0057 Dallas Texas 75246 —
Local Institution - 0045 Houston Texas 77030 —
Local Institution - 0008 Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01968109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 6, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01968109 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →