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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • 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

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
Intervention / Treatment
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

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

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

Bristol-Myers Squibb

Investigators

  • 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)

May 30, 2018

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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