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

March 17, 2026 updated by: Bristol-Myers Squibb

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

The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0012
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0011
  • France
      • Marseille, France, 13385
        • Local Institution - 0017
      • Toulouse, France, 31059
        • Local Institution - 0016
      • Villejuif, France, 94800
        • Local Institution - 0015
  • Italy
      • Forlì, Italy, 47014
        • Local Institution - 0010
      • Naples, Italy, 80131
        • Local Institution - 0009
      • Rome, Italy, 00144
        • Local Institution - 0023
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution - 0019
      • Madrid, Spain, 28041
        • Local Institution - 0021
      • Madrid, Spain, 28050
        • Local Institution - 0018
      • Málaga, Spain, 29011
        • Local Institution - 0022
      • Pamplona, Spain, 31008
        • Local Institution - 0020
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Local Institution - 0008
      • Zurich, Switzerland, 8091
        • Local Institution - 0007
  • United Kingdom
      • Headington, United Kingdom, OX3 7LE
        • Local Institution - 0013
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Local Institution - 0014
  • United States
    • California
      • Duarte, California, United States, 91010
        • Local Institution - 0006
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0003
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Local Institution - 0004
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0005
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
  • Available tumor tissue for biomarker analysis
  • Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

Exclusion Criteria:

  • Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
  • History of interstitial lung disease / pneumonitis
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986205
Specified dose on specified days
Other Names:
  • Linrodostat
Biological: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Biological: Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986016

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Time Frame: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)

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.
From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
Number of Participants With Adverse Events and Deaths
Time Frame: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
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.
From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
Number of Participants With Dose Limiting Toxicities
Time Frame: From first dose (Day 1) and up to 42 days post first dose
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.
From first dose (Day 1) and up to 42 days post first dose
Objective Response Rate (ORR)
Time Frame: 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)
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.
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)
Disease Control Rate (DCR)
Time Frame: 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)
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.
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)
Duration of Response (DoR)
Time Frame: 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)
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.
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the date of first dose (Day 1) to up to the date of the first documented disease progression or death (up to approximately 80 months)
Progression-Free Survival (PFS) is the time from randomization or treatment start until the first documented disease progression or death from any cause, whichever occurs first, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death are censored at the date of last adequate tumor assessment. PFS is typically analyzed using Kaplan-Meier estimates and reported in months.
From the date of first dose (Day 1) to up to the date of the first documented disease progression or death (up to approximately 80 months)
Progression Free Survival Rate at 6 and 12 Months
Time Frame: Month 6 and 12
Progression-Free Survival Rate (PFSR) is the percentage of participants who remain alive without disease progression, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death by the time point are considered event-free
Month 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA224-048
  • 2018-000058-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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