An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

22 sites in 7 countries.

About this study

Official title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Conditions

Advanced Cancer

Being tested

Relatlimab, Nivolumab, BMS-986205, Ipilimumab

Keywords

Immunotherapy, Relatlimab, Nivolumab, Ipilimumab, BMS-986205

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• RelatlimabBiological

  Also called BMS-986016

  Specified dose on specified days

• NivolumabBiological

  Also called Opdivo, BMS-936558

  Specified dose on specified days

• BMS-986205Drug

  Also called Linrodostat

  Specified dose on specified days

• IpilimumabBiological

  Also called Yervoy, BMS-734016

  Specified dose on specified days

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants With Grade 3/Grade 4 Laboratory Test Results

   Laboratory test results are graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

   Grade 3 = Severe or medically significant but not immediately life-threatening. Grade 4 = Life-threatening or disabling.

   Measured: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)

2. Number of Participants With Adverse Events and Deaths

   Adverse events are any unfavorable or unintended signs, symptoms, or diseases occurring in study participants during a clinical trial, regardless of whether they are related to the intervention. They include all-cause mortality, serious adverse events, and other events exceeding a set frequency threshold. Serious adverse events are a subset that result in significant outcomes such as death, life-threatening conditions, hospitalization or its prolongation, persistent or significant disability/incapacity, or other medically important conditions.

   Measured: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)

3. Number of Participants With Dose Limiting Toxicities

   Dose-Limiting Toxicities (DLTs) are treatment-related adverse events occurring during the first cycle (typically Days 1-28) that meet predefined severity criteria per NCI CTCAE v4.03. Hematologic DLTs include Grade 4 neutropenia >5 days, Grade 3 neutropenia with fever, Grade 4 thrombocytopenia or Grade 3 with bleeding, and Grade 4 anemia. Non-hematologic DLTs include any toxicity ≥Grade 3 (except alopecia or controlled nausea) or treatment interruption ≥2 weeks due to adverse events.

   Measured: From first dose (Day 1) and up to 42 days post first dose

4. Objective Response Rate (ORR)

   Objective Response Rate (ORR) is the percentage of participants whose best overall response is Complete Response (CR) or Partial Response (PR) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. ORR is calculated as: (Number of participants with CR or PR ÷ Total participants) × 100. Confidence intervals are typically estimated using the Clopper-Pearson method.

   Measured: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)

5. Disease Control Rate (DCR)

   Disease Control Rate (DCR) is the percentage of participants whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of any pathological lymph nodes to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study. DCR is calculated as: (Number of participants with CR, PR, or SD ÷ Total participants) × 100.

   Measured: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)

6. Duration of Response (DoR)

   Duration of Response (mDOR) is the median time from the first documented occurrence of Complete Response (CR) or Partial Response (PR) until disease progression or death, assessed per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. Progression is defined as at least a 20% increase in the sum of diameters of target lesions or appearance of new lesions.

   Measured: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Mar 2018
2. Study start30 May 2018
3. Primary completion19 Feb 2025
4. Study completion19 Feb 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Advanced CancerStudies of the same condition, open and under way.
• More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.