Trial · NCT05002569

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

NCT05002569, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2026-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma. Trials, record NCT05002569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05002569

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
NCT number: NCT05002569
Status: Terminated
Phases: Phase 3
Enrollment: 1,093 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Melanoma
Interventions: Nivolumab, Nivolumab + Relatlimab Fixed Dose Combination
First posted: 2021-08-12
Last updated: 2026-01-08
Other registries' IDs: eudract:2021-001641-13
Results first posted: 2026-01-08

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Recurrence Free Survival (RFS)	Approximately 27.5 Months	RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
Secondary	Overall Survival (OS)	Approximately 27.5 Months	OS is defined as the time between the date of randomization and the date of death due to any cause.
Secondary	Distant Metastasis Free Survival (DMFS)	Approximately 27.5 Months	DMFS is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first.
Secondary	Progression Free Survival on Next-Line Systemic Therapy (PFS2)	Approximately 27.5 Months	PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first.
Secondary	Number of Participants With Safety Related Events	Approximately 27.5 Months	Safety related events encompass the following measures: Adverse events (AEs), Serious AEs, AEs leading to discontinuation, Drug-Related AEs and Deaths. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An SAE is an AE which: * Results in death * Is life threatening * Requires hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event
Secondary	Number of Participants With Select AEs	Approximately 27.5 Months	Select AEs will be reported as AEs per organ class. Organ classes which will be reported: * Gastrointestinal * Hepatic * Pulmonary * Renal * Skin * Hypersensitivity/Infusion reaction
Secondary	Number of Participants With Endocrine Related Immune Mediated AEs	Approximately 27.5 Months	Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Secondary	Number of Participants With Non-endocrine Related Immune Mediated AEs	Approximately 27.5 Months	Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Secondary	Laboratory Abnormalities for Specific Thyroid Tests	Approximately 27.5 Months	Number of participants with laboratory abnormalities in specific thyroid tests.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recurrence Free Survival (RFS)	Approximately 27.5 Months	All Randomized Participants	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Approximately 27.5 Months	All Randomized Participants	Months	MEDIAN
SECONDARY	Distant Metastasis Free Survival (DMFS)	Approximately 27.5 Months	All Randomized Participants with Resected Stage 3/4a/4b Melanoma at study entry	Months	MEDIAN
SECONDARY	Progression Free Survival on Next-Line Systemic Therapy (PFS2)	Approximately 27.5 Months	All Randomized Participants	Months	MEDIAN
SECONDARY	Number of Participants With Safety Related Events	Approximately 27.5 Months	All Treated Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Select AEs	Approximately 27.5 Months	All Treated Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Endocrine Related Immune Mediated AEs	Approximately 27.5 Months	All Treated Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Non-endocrine Related Immune Mediated AEs	Approximately 27.5 Months	All Treated Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Laboratory Abnormalities for Specific Thyroid Tests	Approximately 27.5 Months	All Treated Participants with at least one on treatment TSH measurement	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Recurrence Free Survival (RFS)	Treatment 1		NA	Full Range 0 to 37.7	Months
Recurrence Free Survival (RFS)	Treatment 2		33.84	Full Range 0 to 37.7	Months
Overall Survival (OS)	Treatment 1		NA	95% Confidence Interval NA to NA	Months
Overall Survival (OS)	Treatment 2		NA	95% Confidence Interval NA to NA	Months
Distant Metastasis Free Survival (DMFS)	Treatment 1		NA	95% Confidence Interval NA to NA	Months
Distant Metastasis Free Survival (DMFS)	Treatment 2		NA	95% Confidence Interval 33.84 to NA	Months
Progression Free Survival on Next-Line Systemic Therapy (PFS2)	Treatment 1		NA	95% Confidence Interval NA to NA	Months
Progression Free Survival on Next-Line Systemic Therapy (PFS2)	Treatment 2		NA	95% Confidence Interval NA to NA	Months
Number of Participants With Safety Related Events	Treatment 1	AEs	522		Participants
Number of Participants With Safety Related Events	Treatment 2	AEs	520		Participants

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized	STARTED	Treatment 1	547
Randomized	STARTED	Treatment 2	546
Randomized	COMPLETED	Treatment 1	543
Randomized	COMPLETED	Treatment 2	545
Randomized	NOT COMPLETED	Treatment 1	4
Randomized	NOT COMPLETED	Treatment 2	1
Treatment Period	STARTED	Treatment 1	543
Treatment Period	STARTED	Treatment 2	545
Treatment Period	COMPLETED	Treatment 1	283
Treatment Period	COMPLETED	Treatment 2	327

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events534

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Treatment 1	36	543
other	Anaemia	Blood and lymphatic system disorders	Treatment 2	25	545
other	Hyperthyroidism	Endocrine disorders	Treatment 1	96	543
other	Hyperthyroidism	Endocrine disorders	Treatment 2	60	545
other	Hypophysitis	Endocrine disorders	Treatment 1	37	543
other	Hypophysitis	Endocrine disorders	Treatment 2	10	545
other	Hypothyroidism	Endocrine disorders	Treatment 1	150	543
other	Hypothyroidism	Endocrine disorders	Treatment 2	85	545
other	Abdominal pain	Gastrointestinal disorders	Treatment 1	31	543
other	Abdominal pain	Gastrointestinal disorders	Treatment 2	24	545

1 to 10 of 534Source ClinicalTrials.gov

See all 534 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment 1	86	547
Total, all-cause mortality	Treatment 2	76	546
Total, other adverse events	Treatment 1	489	543
Total, other adverse events	Treatment 2	473	545
Total, serious adverse events	Treatment 1	174	543
Total, serious adverse events	Treatment 2	121	545

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
41109920	DERIVED	PubMed
42770835	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment 1 vs Treatment 2: deaths from any cause	Trial comparisons
Treatment 1 vs Treatment 2: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05002569

GET https://conductscience.org/api/trials/v1/NCT05002569/results?page=2

API reference For AI assistants