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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510913-13-00

Acronym

CA224-047

Enrollment

340

Registered

2024-04-10

Start date

2018-05-18

Completion date

Unknown

Last updated

2025-10-06

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

Brief summary

Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR), PFS Phase 2 portion of trial, assessed by a BICR

Detailed description

Phase 3 portion of trial: Overall Survival (OS), Phase 3 portion of trial: ORR , assessed by a BICR, Phase 2 portion of trial: ORR , assessed by a BICR. In the randomized population and in subgroups, Phase 2 portion of trial: Duration of Response (DOR) in the randomized population and in subgroups, Phase 2 portion of trial: PFS in subgroups, Phase 2 portion of trial: OS in the randomized population and in subgroups, Phase 2 portion of the trial: Number of Adverse Events (AEs), Phase 2 portion of the trial: Number of Serious Adverse Events (SAEs), Phase 2 portion of the trial: Number of AEs Leading to Discontinuation, Phase 2 portion of the trial: Number of Deaths, Phase 2 portion of the trial: Number of Laboratory Abnormalities

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGNivolumab/Relatlimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR), PFS Phase 2 portion of trial, assessed by a BICR	—

Secondary

Measure	Time frame
Phase 3 portion of trial: Overall Survival (OS), Phase 3 portion of trial: ORR , assessed by a BICR, Phase 2 portion of trial: ORR , assessed by a BICR. In the randomized population and in subgroups, Phase 2 portion of trial: Duration of Response (DOR) in the randomized population and in subgroups, Phase 2 portion of trial: PFS in subgroups, Phase 2 portion of trial: OS in the randomized population and in subgroups, Phase 2 portion of the trial: Number of Adverse Events (AEs), Phase 2 portion of the trial: Number of Serious Adverse Events (SAEs), Phase 2 portion of the trial: Number of AEs Leading to Discontinuation, Phase 2 portion of the trial: Number of Deaths, Phase 2 portion of the trial: Number of Laboratory Abnormalities	—

Measure

Time frame

—

Countries

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Norway, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026