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  • NCT03470922

Active, Not Recruiting

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma - CA224-047

Updated: 15 September, 2023   |   ClinicalTrials.gov

What to expect from the CA224-047 melanoma clinical trial

What to expect from the CA224-047 melanoma clinical trial

  • 1

    Screening

    1-2 weeks

    1 office visit

    We’ll begin by learning about you and your condition, to make sure that the trial is a good fit for you.

  • 2

    Treatment

    108 weeks

    27 office visits

    You’ll be randomly placed in one of two groups to receive your assigned study drug. You won’t know which group you have been placed in, and neither will the study team.

  • 3

    Follow Up

    14-16 weeks

    2+ office visits

    We’ll continue to monitor your condition even after you receive your final dose.

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page CA224-047
Download Study Participant’s Guide

SELECT LANGUAGE

Might I be eligible for this melanoma trial?

Here is a quick summary of the key criteria for taking part in this melanoma trial. We are looking for people who:

  • Are aged 12 years or above
  • Have been diagnosed with unresectable stage III (stage 3) or metastatic stage IV (stage 4) melanoma
  • Have no history of systemic anticancer therapy for unresectable or metastatic melanoma (in some cases, prior therapy is allowed) 
  • Are able to provide samples of tumor tissue taken from an unresectable or metastatic site of disease

Trial Details

  • Phase 2/Phase 3

    Phase

  • Gender(s)

  • 12+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Relatlimab + Nivolumab
Biological: Relatlimab, Nivolumab
Experimental: Arm B: Nivolumab
Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 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 Other protocol defined inclusion/exclusion criteria could apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001