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

  • identifier


  • Recruitment Status


  • First Posted

    March 8, 2018

  • Last update posted

    October 22, 2020

Study Description

Brief summary:

The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Biological: Relatlimab
    Biological: Nivolumab
    Drug: BMS-986205
    Biological: Ipilimumab
  • Phase: Phase 1/Phase 2

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 230 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2018
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
Biological: Relatlimab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Drug: BMS-986205
Specified dose on specified days
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
Biological: Relatlimab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
  • 2. Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
  • 3. Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]
  • 4. Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
  • 5. Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
  • 6. Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
  • 7. Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  • 8. Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
  • Secondary Outcome Measures: 1. Progression Free Survival (PFS) [ Time Frame: up to 4 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit Inclusion Criteria: - Histologic or cytologic confirmation of an incurable solid malignancy that is 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: - Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease - Participants with a history of interstitial lung disease (ILD) / pneumonitis - Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations


Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

Contact: First line of the email MUST contain NCT # and Site #.


United States, California
City of Hope National Medical Center

United States, Colorado
University Of Colorado

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

United States, Missouri
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis

United States, Tennessee
The West Clinic, P.C.

United States, Washington
Local Institution

Australia, New South Wales
Melanoma Institute Australia
North Sydney

Australia, Western Australia
Linear Clinical Research Ltd

Hopital De La Timone
Marseille Cedex 5

Institut Claudius Regaud

Institut Gustave Roussy

IRST Meldola

Istituto Nazionale Tumori Fondazione Pascale

Hospital Clinic I Provincial

Centro Integral Oncologico Clara Campal

Clinica Universidad de Navarra

Chu Vaudois Lausanne

Universitaetsspital Zuerich

United Kingdom
Local Institution
Newcastle Upon Tyne

United Kingdom
Local Institution

Sponsors and Collaborators

Bristol-Myers Squibb


Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • Identifier: NCT03459222 History of Changes
  • Other Study ID Numbers: CA224-048, 2018-000058-22
  • First Posted: March 8, 2018 Key Record Dates
  • Last Update Posted: October 22, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Relatlimab immunotherapy