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
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.
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
- Enrollment
- 1,482 participants
Conditions and interventions
Conditions
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 4, 2013
- Primary completion
- May 21, 2024
- Completion
- Feb 2, 2025
- Last update posted
- Apr 5, 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 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01968109 live on ClinicalTrials.gov.