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NCT01968109 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,482
- Enrollment target
NCT01968109: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01968109 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,482 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2370% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968109, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,482 participants
- Enrollment target
Study 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.
Primary Outcome
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Relatlimab
- BIOLOGICAL BMS-986213
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,482 participants |
| Start Date | 2013-11-05 |
| Est. Completion | 2025-02-03 |
| Phase | Phase 1 |
What the finished NCT01968109 record still lists
NCT01968109 is an interventional study that assigns participants to a tested intervention. Its 1,482 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2370% higher).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT01968109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968109 about?
NCT01968109 is a clinical study titled "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". 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 t...
What is the current status of trial NCT01968109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,482 participants. The study started on 2013-11-05. Estimated completion is 2025-02-03.
What interventions are being tested in trial NCT01968109?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Relatlimab (BIOLOGICAL), BMS-986213 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01968109?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01968109's enrollment target sits among peer trials
1,482 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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