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

September 14, 2023 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

Study Type

Interventional

Enrollment (Estimated)

255

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

    • New South Wales
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0012
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0011
      • Marseille Cedex 5, France, 13385
        • Hopital de La Timone
      • Toulouse Cedex 9, France, 31059
        • Institut Claudius Regaud
      • Villejuif, France, 94800
        • Institute Gustave Roussy
      • Forlì, Italy, 47014
        • Local Institution - 0010
      • Napoli, Italy, 80131
        • Local Institution - 0009
      • Rome, Italy, 00144
        • Local Institution - 0023
      • 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
      • Lausanne, Switzerland, 1011
        • Local Institution - 0008
      • Zuerich, Switzerland, 8091
        • Local Institution - 0007
      • Headington, United Kingdom, OX3 7LE
        • Local Institution - 0013
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Local Institution - 0014
    • 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
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0005
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution
    • 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
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Specified dose on specified days
Other Names:
  • Linrodostat
Specified dose on specified days
Other Names:
  • BMS-986016
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Specified dose on specified days
Other Names:
  • BMS-986016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of clinical laboratory test abnormalities
Time Frame: Approximately 4 years
Approximately 4 years
Number of Adverse Events (AEs)
Time Frame: Approximately 4 years
Approximately 4 years
Number of Serious Adverse Events (SAEs)
Time Frame: Approximately 4 years
Approximately 4 years
Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 6 weeks
Up to 6 weeks
Number of AEs leading to discontinuation
Time Frame: Approximately 4 years
Approximately 4 years
Number of AEs leading to death
Time Frame: Approximately 4 years
Approximately 4 years
Objective Response Rate (ORR)
Time Frame: Approximately 4 years
Approximately 4 years
Disease Control Rate (DCR)
Time Frame: Approximately 4 years
Approximately 4 years
Median Duration of Response (mDOR)
Time Frame: Approximately 4 years
Approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

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

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.

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 (Estimated)

April 22, 2024

Study Completion (Estimated)

November 10, 2026

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)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

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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