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A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

NCT03978611

Description:

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment
  • Official Title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

Clinical Trial IDs

  • ORG STUDY ID: CA224-083
  • SECONDARY ID: 2019-000132-25
  • NCT ID: NCT03978611

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
RelatlimabPart 1: Dose Escalation Phase
IpilimumabPart 1: Dose Escalation Phase

Purpose

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation PhaseExperimental
  • Relatlimab
  • Ipilimumab
Part 2: Dose Expansion PhaseExperimental
  • Relatlimab
  • Ipilimumab

Eligibility Criteria

        Inclusion Criteria:

          -  Must have documented progression while on a prior anti-programmed cell death protein 1
             (PD-1) containing regimen.

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test

          -  Participants must have histologically confirmed advanced unresectable (Stage III) or
             metastatic (Stage IV) melanoma, as per AJCC staging system

          -  Tumor tissue from an unresectable or metastatic site of disease must be provided for
             biomarker analyses.

          -  BRAF wild type and mutant participants are eligible

          -  Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Ability to comply with treatment, patient-reported outcomes (PROs), PK, and
             pharmacodynamic sample collection and required study follow-up

        Exclusion Criteria:

          -  History of uveal melanoma

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome

          -  Prior treatment with ipilimumab, relatlimab, or any other CTLA-4 or LAG-3 targeted
             agents

          -  Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1
             and HIV-2 antibody.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events (AEs)
Time Frame:Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response (DOR)
Time Frame:Approximately Up to 2.4 years
Safety Issue:
Description:
Measure:Median PFS
Time Frame:6 and 12 months
Safety Issue:
Description:
Measure:Median Overall Survival (OS)
Time Frame:1 and 2 years
Safety Issue:
Description:
Measure:Number of Participants with Anti-Drug Antibodies (ADA)-Positivity
Time Frame:Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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