A Phase I/II 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

Study Identifier:
CA224-048
CT.gov Identifier:
NCT03459222
EudraCT Identifier:
2018-000058-22
EU Trial (CTIS) Number:
2023-508207-21-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

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.

Medical Condition
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.
Melanoma
Solid Tumor
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 I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Arms:
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Drug: ASCO 2024:
Study Status
Indicates the current recruitment status or the expanded access status
Study Complete

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Melanoma
Solid Tumor