A Study of Relatlimab plus Nivolumab Versus Nivolumab Alone in Participants with Advanced Melanoma

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003583-12-DE

Enrollment

1000

Registered

2018-02-21

Start date

2018-06-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Untreated Metastatic or Unresectable Melanoma MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Product Name: Relatlimab/ Nivolumab 1:3 Fixed Dose Combination Product Code: BMS-986213 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system - Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma - Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 690 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - Participants must not have active brain metastases or leptomeningeal metastases - Participants must not have uveal melanoma - Participants must not have an active, known, or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 3 portion of the trial - To compare progression-free survival (PFS) of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma. Phase 2 portion of the trial - To compare PFS of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma. ;Secondary Objective: Phase 3 portion of the trial - To compare OS of BMS-986213 to nivolumab monotherapy in subjects with previously untreated, unresectable or metastatic melanoma - To compare ORR of BMS-986213 to nivolumab in subjects with unresectable or metastatic melanoma Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To estimate the treatment effect, measured by ORR, as determined by BICR using RECISTv1.1 in all-comers and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To evaluate DOR, PFS rates at pre-specified time points based on BICR assessments using RECIST v1.1 in the randomized population (for DOR) and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To assess the 1- and 2-year OS rate in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To assess safety and tolerability;Primary end point(s): Primary Outcome Measures: 1/ Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR) 2/ PFS Phase 2 portion of trial, assessed by a BICR;Timepoint(s) of evaluation of this end point: Time Frame: 1/ Up to 5 years 2/ Up to 5 years	—

Measure

Time frame

Main Objective: Phase 3 portion of the trial - To compare progression-free survival (PFS) of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma. Phase 2 portion of the trial - To compare PFS of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma. ;Secondary Objective: Phase 3 portion of the trial - To compare OS of BMS-986213 to nivolumab monotherapy in subjects with previously untreated, unresectable or metastatic melanoma - To compare ORR of BMS-986213 to nivolumab in subjects with unresectable or metastatic melanoma Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To estimate the treatment effect, measured by ORR, as determined by BICR using RECISTv1.1 in all-comers and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To evaluate DOR, PFS rates at pre-specified time points based on BICR assessments using RECIST v1.1 in the randomized population (for DOR) and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To assess the 1- and 2-year OS rate in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status - To assess safety and tolerability;Primary end point(s): Primary Outcome Measures: 1/ Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR) 2/ PFS Phase 2 portion of trial, assessed by a BICR;Timepoint(s) of evaluation of this end point: Time Frame: 1/ Up to 5 years 2/ Up to 5 years

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures: 1/ Overall Survival (OS) Phase 3 portion of trial 2/ ORR Phase 3 portion of trial, assessed by a BICR 3/ ORR Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups 4/ Duration of Response (DOR) Phase 2 portion of trial. In the randomized population and in subgroups 5/ PFS Phase 2 portion of trial. In subgroups 6/ OS Phase 2 portion of trial. In the randomized population and in subgroups 7/ Number of Adverse Events (AEs) Phase 2 portion of the trial 8/ Number of Serious Adverse Events (SAEs) Phase 2 portion of the trial 9/ Number of AEs Leading to Discontinuation Phase 2 portion of the trial 10/ Number of Deaths Phase 2 portion of the trial 11/ Number of Laboratory Abnormalities Phase 2 portion of the trial;Timepoint(s) of evaluation of this end point: 1/ Time Frame: Up to 5 years 2/ Time Frame: Up to 5 years 3/ Time Frame: Up to 5 years 4/ Time Frame: Up to 5 years 5/ Time Frame: Up to 5 years 6/ Time Frame: Up to 5 years 7/ Time Frame: Up to 5 years 8/ Time Frame: Up to 5 years 9/ Time Frame: Up to 5 years 10/ Time Frame: Up to 5 years 11/ Time Frame: Up to 5 years	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures: 1/ Overall Survival (OS) Phase 3 portion of trial 2/ ORR Phase 3 portion of trial, assessed by a BICR 3/ ORR Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups 4/ Duration of Response (DOR) Phase 2 portion of trial. In the randomized population and in subgroups 5/ PFS Phase 2 portion of trial. In subgroups 6/ OS Phase 2 portion of trial. In the randomized population and in subgroups 7/ Number of Adverse Events (AEs) Phase 2 portion of the trial 8/ Number of Serious Adverse Events (SAEs) Phase 2 portion of the trial 9/ Number of AEs Leading to Discontinuation Phase 2 portion of the trial 10/ Number of Deaths Phase 2 portion of the trial 11/ Number of Laboratory Abnormalities Phase 2 portion of the trial;Timepoint(s) of evaluation of this end point: 1/ Time Frame: Up to 5 years 2/ Time Frame: Up to 5 years 3/ Time Frame: Up to 5 years 4/ Time Frame: Up to 5 years 5/ Time Frame: Up to 5 years 6/ Time Frame: Up to 5 years 7/ Time Frame: Up to 5 years 8/ Time Frame: Up to 5 years 9/ Time Frame: Up to 5 years 10/ Time Frame: Up to 5 years 11/ Time Frame: Up to 5 years

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactHead of the GSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026