Trial Outcomes & Findings for 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 NCT05665595)

Last Updated: 2025-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1594 participants

Primary outcome timeframe

Up to approximately 13 months

Results posted on

2025-10-15

Participant Flow

Protocol-specified final analysis for the following results, including the participant flow, was performed on 1402 participants that enrolled within the primary completion data cut-off. Analysis of the remaining 192 enrolled participants will be included in the End of Trial analysis.

Participant milestones

Participant milestones
Measure	Pembrolizumab/Vibostolimab Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Pembrolizumab Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Overall Study STARTED	701	701
Overall Study Treated	698	700
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	701	701

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab/Vibostolimab Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Pembrolizumab Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Overall Study Ongoing	692	698
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	1	0
Overall Study Death	6	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab/Vibostolimab n=701 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Pembrolizumab n=701 Participants Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Total n=1402 Participants Total of all reporting groups
Age, Continuous	59.0 Years STANDARD_DEVIATION 13.8 • n=5 Participants	59.2 Years STANDARD_DEVIATION 13.9 • n=7 Participants	59.1 Years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	282 Participants n=5 Participants	291 Participants n=7 Participants	573 Participants n=5 Participants
Sex: Female, Male Male	419 Participants n=5 Participants	410 Participants n=7 Participants	829 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	84 Participants n=5 Participants	73 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	585 Participants n=5 Participants	586 Participants n=7 Participants	1171 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	42 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	134 Participants n=5 Participants	139 Participants n=7 Participants	273 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	553 Participants n=5 Participants	554 Participants n=7 Participants	1107 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Risk-based Melanoma Stage Stage IIB/IIC/clinical IIB and IIC/IIIA/IIIB	427 Participants n=5 Participants	427 Participants n=7 Participants	854 Participants n=5 Participants
Risk-based Melanoma Stage Stage IIIC/IIID/IV	274 Participants n=5 Participants	274 Participants n=7 Participants	548 Participants n=5 Participants
Region of Enrollment Asia	133 Participants n=5 Participants	135 Participants n=7 Participants	268 Participants n=5 Participants
Region of Enrollment Rest of the World (ROW)	568 Participants n=5 Participants	566 Participants n=7 Participants	1134 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 13 months

Population: Per protocol, analysis population consisted of all participants randomized, by the primary completion data cut-off.

Outcome measures

Outcome measures
Measure	Pembrolizumab/Vibostolimab n=701 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Pembrolizumab n=701 Participants Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Recurrence-Free Survival (RFS)	NA Months Median, upper limit, and lower limit not reached at the time of data cut-off due to insufficient number of participants with an event.	NA Months Median, upper limit, and lower limit not reached at the time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 31 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 31 months

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab/Vibostolimab

Serious events: 109 serious events

Other events: 462 other events

Deaths: 6 deaths

Pembrolizumab

Serious events: 57 serious events

Other events: 426 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pembrolizumab/Vibostolimab n=698 participants at risk Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).	Pembrolizumab n=700 participants at risk Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Endocrine disorders Hyperthyroidism	12.6% 88/698 • Number of events 97 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	11.4% 80/700 • Number of events 82 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	9.5% 66/698 • Number of events 67 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	9.1% 64/700 • Number of events 65 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	9.5% 66/698 • Number of events 80 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	10.1% 71/700 • Number of events 89 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	6.7% 47/698 • Number of events 55 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	8.3% 58/700 • Number of events 73 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	5.0% 35/698 • Number of events 42 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	2.7% 19/700 • Number of events 21 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	18.8% 131/698 • Number of events 148 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	20.6% 144/700 • Number of events 166 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	9.7% 68/698 • Number of events 79 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	9.9% 69/700 • Number of events 80 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	9.2% 64/698 • Number of events 73 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	7.4% 52/700 • Number of events 60 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 75/698 • Number of events 97 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	9.9% 69/700 • Number of events 80 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Headache	8.7% 61/698 • Number of events 70 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	6.9% 48/700 • Number of events 58 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 43/698 • Number of events 45 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	4.9% 34/700 • Number of events 36 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	25.5% 178/698 • Number of events 202 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	13.0% 91/700 • Number of events 100 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	23.9% 167/698 • Number of events 194 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	10.9% 76/700 • Number of events 91 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.9% 48/698 • Number of events 57 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 22/700 • Number of events 27 • Up to approximately 13 months All-cause mortality: all participants randomized by the primary completion data cut-off. AEs: all participants randomized by the primary completion data cut-off who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER