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.
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
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Arm A: Relatlimab + Nivolumab |
Relatlimab | BMS-986016 | Arm 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
Name | Type | Description | Interventions |
---|
Arm A: Relatlimab + Nivolumab | Experimental | Combination | |
Arm B: Nivolumab | Experimental | Monotherapy | |
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