NCT03470922 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2, PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2025-09-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · NOT POSTED

Overall Survival (OS)

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outcome · NOT POSTED

Overall Response Rate (ORR)

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outcome · POSTED

The Number of Participants Experiencing Adverse Events (AEs)

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outcome · POSTED

The Number of Participants Experiencing Serious Adverse Events (SAEs)

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outcome · POSTED

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

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outcome · POSTED

The Number of Participant Deaths in the Study

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outcome · POSTED

The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

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outcome · POSTED

The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 12 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Combination
intervention Names
Biological: Relatlimab
Biological: Nivolumab
label
Arm A: Relatlimab + Nivolumab
type
EXPERIMENTAL
description
Monotherapy
intervention Names
Biological: Nivolumab
label
Arm B: Nivolumab
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A: Relatlimab + Nivolumab
description
Specified dose on specified day
name
Relatlimab
type
BIOLOGICAL
arm Group Labels
Arm A: Relatlimab + Nivolumab
Arm B: Nivolumab
description
Specified dose on specified days
name
Nivolumab
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 714
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
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.
measure
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)
description
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.
measure
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)
description
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.
measure
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)
description
The number of participant deaths in the study.
measure
The Number of Participant Deaths in the Study
time Frame
From first dose up to approximately 33 months
description
The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.
measure
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)
description
The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.
measure
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)

primary Outcomes

description
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.
measure
Progression Free Survival (PFS)
time Frame
From randomization to date of first documented tumor progression or death (up to approximately 33 months)

secondary Outcomes

description
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").
measure
Overall Survival (OS)
time Frame
From randomization to the date of death (up to approximately 3 years)
description
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).
measure
Overall Response Rate (ORR)
time Frame
From randomization up to approximately 3 years

Full study description

brief Summary: 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.

Source references

references

citation
Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
pmid
41811823
type
DERIVED
citation
Regan MM, Ascierto PA MD, Lipson EJ, Palaia J, Moshyk A, Selvan A, Lao CD, Atkins MB MD, McDermott DF, Potluri R, Ranjan S, Bilthare S, Long GV, Stephen Hodi F, Tawbi H, Schadendorf D. Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. J Immunother Cancer. 2025 Sep 12;13(9):e012747. doi: 10.1136/jitc-2025-012747.
pmid
40940136
type
DERIVED
citation
Lipson EJ, Stephen Hodi F, Tawbi H, Schadendorf D, Ascierto PA, Matamala L, Gutierrez EC, Rutkowski P, Gogas HJ, Lao CD, Menezes JJ, Dalle S, Arance A, Gaudy-Marqueste C, Chen B, Jackson W, Mukherjee S, Dolfi S, Long GV. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. 2025 Jul 25;225:115547. doi: 10.1016/j.ejca.2025.115547. Epub 2025 Jun 3.
pmid
40513285
type
DERIVED
citation
Tawbi HA, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas H, Lao CD, Janoski De Menezes J, Dalle S, Arance AM, Grob JJ, Ratto B, Rodriguez S, Mazzei A, Dolfi S, Long GV. Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. J Clin Oncol. 2025 May;43(13):1546-1552. doi: 10.1200/JCO.24.01124. Epub 2024 Dec 13.
pmid
39671533
type
DERIVED
citation
Long GV, Stephen Hodi F, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Salman P, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, Janoski De Menezes J, Dalle S, Arance A, Grob JJ, Keidel S, Shaikh A, Sobiesk AM, Dolfi S, Tawbi HA. Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. NEJM Evid. 2023 Apr;2(4):EVIDoa2200239. doi: 10.1056/EVIDoa2200239. Epub 2023 Mar 22.
pmid
38320023
type
DERIVED
citation
Schadendorf D, Tawbi H, Lipson EJ, Stephen Hodi F, Rutkowski P, Gogas H, Lao CD, Grob JJ, Moshyk A, Lord-Bessen J, Hamilton M, Guo S, Shi L, Keidel S, Long GV. Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. Eur J Cancer. 2023 Jul;187:164-173. doi: 10.1016/j.ejca.2023.03.014. Epub 2023 Mar 22.
pmid
37167764
type
DERIVED
citation
Raschi E, Comito F, Massari F, Gelsomino F. Relatlimab and nivolumab in untreated advanced melanoma: insight into RELATIVITY. Immunotherapy. 2023 Feb;15(2):85-91. doi: 10.2217/imt-2022-0172. Epub 2023 Jan 11.
pmid
36628573
type
DERIVED
citation
Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.
pmid
34986285
type
DERIVED