Trial · NCT05665595

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

NCT05665595, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2025-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010). Trials, record NCT05665595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05665595

On this page

Trial

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

Title: A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
NCT number: NCT05665595
Status: Terminated
Phases: Phase 3
Enrollment: 1,594 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Melanoma
Interventions: Pembrolizumab/Vibostolimab, Pembrolizumab
First posted: 2022-12-27
Last updated: 2026-09-10
Results first posted: 2025-04-06

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Recurrence-Free Survival (RFS)	Up to approximately 13 months	RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off.
Secondary	Number of Participants Who Experienced At Least One or More Adverse Events (AE)	Up to approximately 20 months	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
Secondary	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 18 months	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.

Source ClinicalTrials.gov

Outcomes3

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)	Up to approximately 13 months	Per protocol, analysis population consisted of all participants randomized, by the primary completion data cut-off.	Months	MEDIAN
SECONDARY	Number of Participants Who Experienced at Least One Adverse Event (AE)	Up to approximately 31 months
SECONDARY	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 31 months

Source ClinicalTrials.gov

Results by group2

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)	Pembrolizumab/Vibostolimab		NA	95% Confidence Interval NA to NA	Months
Recurrence-Free Survival (RFS)	Pembrolizumab		NA	95% Confidence Interval NA to NA	Months

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab/Vibostolimab	701
Overall Study	STARTED	Pembrolizumab	701
Overall Study	Treated	Pembrolizumab/Vibostolimab	698
Overall Study	Treated	Pembrolizumab	700
Overall Study	COMPLETED	Pembrolizumab/Vibostolimab	0
Overall Study	COMPLETED	Pembrolizumab	0
Overall Study	NOT COMPLETED	Pembrolizumab/Vibostolimab	701
Overall Study	NOT COMPLETED	Pembrolizumab	701

Source ClinicalTrials.gov

Adverse events302

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	Events
other	Hyperthyroidism	Endocrine disorders	Pembrolizumab/Vibostolimab	88	698	97
other	Hyperthyroidism	Endocrine disorders	Pembrolizumab	80	700	82
other	Hypothyroidism	Endocrine disorders	Pembrolizumab/Vibostolimab	66	698	67
other	Hypothyroidism	Endocrine disorders	Pembrolizumab	64	700	65
other	Diarrhoea	Gastrointestinal disorders	Pembrolizumab/Vibostolimab	66	698	80
other	Diarrhoea	Gastrointestinal disorders	Pembrolizumab	71	700	89
other	Nausea	Gastrointestinal disorders	Pembrolizumab/Vibostolimab	47	698	55
other	Nausea	Gastrointestinal disorders	Pembrolizumab	58	700	73
other	Asthenia	General disorders	Pembrolizumab/Vibostolimab	35	698	42
other	Asthenia	General disorders	Pembrolizumab	19	700	21

1 to 10 of 302Source ClinicalTrials.gov

See all 302 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab/Vibostolimab	6	701
Total, all-cause mortality	Pembrolizumab	1	701
Total, other adverse events	Pembrolizumab/Vibostolimab	462	698
Total, other adverse events	Pembrolizumab	426	700
Total, serious adverse events	Pembrolizumab/Vibostolimab	109	698
Total, serious adverse events	Pembrolizumab	57	700

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39230120	DERIVED	PubMed
41698381	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
Pembrolizumab/Vibostolimab vs Pembrolizumab: deaths from any cause	Trial comparisons
Pembrolizumab/Vibostolimab vs Pembrolizumab: 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/NCT05665595

GET https://conductscience.org/api/trials/v1/NCT05665595/events?page=2

API reference For AI assistants