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Active, Not Recruiting

NCT Number: NCT03470922

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

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Local Institution - 0135, Buenos Aires, Distrito Federal, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relatlimab

Biological

Specified dose on specified day

Nivolumab

Biological

Specified dose on specified days

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months)

    Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization to the date of death (up to approximately 3 years)

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

  2. Overall Response Rate (ORR)

    Time frame: From randomization up to approximately 3 years

    Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

Other outcomes

  1. The Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

    The number of participants experiencing adverse events (AEs).

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  2. The Number of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

    The number of participants experiencing serious adverse events (SAEs).

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

  3. The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

    Time frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

    The number of participants experiencing adverse events (AEs) leading to discontinuation.

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  4. The Number of Participant Deaths in the Study

    Time frame: From first dose up to approximately 33 months

    The number of participant deaths in the study.

  5. The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

    Time frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

    The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

  6. The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests

    Time frame: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

    The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: RELATIVITY-047

Important dates

Study start
2018
Primary completion
2021
Study completion
2030
First posted
Mar 20, 2018
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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