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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 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,482 participants.

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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.

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Relatlimab
  • BIOLOGICAL BMS-986213

Trial Details

FieldValue
Enrollment Target 1,482 participants
Start Date 2013-11-05
Est. Completion 2025-02-03
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01968109

The ClinicalTrials.gov registry entry for NCT01968109 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.

NCT01968109 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.