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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03459222
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : November 1, 2021
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Advanced Cancer Biological: Relatlimab Biological: Nivolumab Drug: BMS-986205 Biological: Ipilimumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 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 30, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified days

Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

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

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03459222

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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 #.

Show Show 24 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03459222    
Other Study ID Numbers: CA224-048
2018-000058-22 ( EudraCT Number )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors