Clinical Trials /

A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

NCT05002569

Description:

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Related Conditions:
  • Melanoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
  • Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Clinical Trial IDs

  • ORG STUDY ID: CA224-098
  • SECONDARY ID: 2021-001641-13
  • NCT ID: NCT05002569

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Arm A: Relatlimab + Nivolumab
RelatlimabBMS-986016Arm A: Relatlimab + Nivolumab

Purpose

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Trial Arms

NameTypeDescriptionInterventions
Arm A: Relatlimab + NivolumabExperimentalCombination
  • Nivolumab
  • Relatlimab
Arm B: NivolumabExperimentalMonotherapy
  • Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit: www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or
             Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have
             histologically confirmed melanoma that is completely surgically resected (free of
             disease) with negative margins in order to be eligible

          -  Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
             of ≤ 1

          -  Complete resection must be performed within 12 weeks prior to randomization

          -  All participants must have disease-free status documented by a complete physical
             examination within 14 days prior to randomization and imaging studies within 35 days
             prior to randomization

          -  Tumor tissue must be provided for biomarker analyses

        Exclusion Criteria:

          -  History of uveal melanoma

          -  Untreated/unresected CNS metastases or leptomeningeal metastases

          -  Active, known, or suspected autoimmune disease

          -  Participants with serious or uncontrolled medical disorder

          -  Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are
             permitted

          -  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 4 weeks prior
             to screening

        Other protocol-defined inclusion/exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence-Free Survival (RFS) time per Investigator assessment
Time Frame:Until recurrence, up to 56 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Time Frame:Until distant progression, up to 56 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Until death, up to 72 months
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Severity of AEs
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Severity of SAEs
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation (DC)
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Severity of AEs leading to DC
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of immune-mediated AEs (IMAEs)
Time Frame:135 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Severity of IMAEs
Time Frame:135 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of drug related AEs
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Severity of drug related AEs
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time Frame:30 days from participant's last dose, up to 56 months
Safety Issue:
Description:
Measure:Duration of Treatment on next line therapies
Time Frame:Until end of next-line therapy, up to 4 years
Safety Issue:
Description:
Measure:Progression-Free Survival 2 (PFS2)
Time Frame:Until second recurrence, up to 4 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • Melanoma
  • Relatlimab
  • Nivolumab
  • Opdivo

Last Updated

August 12, 2021