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CTRI Number  CTRI/2023/07/054670 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Adjuvant MK-7684A vs Pembrolizumab for Resected High-Risk Melanoma 
Scientific Title of Study   A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010) 
Trial Acronym  MK7684A-010/KEYVIBE-010 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MK7684A-010 Version 00 Dated 15 Sep 2022  Protocol Number 
MK7684A-010 Version 02 Dated 15 Mar 2023  Protocol Number 
MK7684A-010 Version 04 Dated 27 Jun 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Monisha Sharma 
Designation  Senior Director- Clinical Research 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54

Gurgaon
HARYANA
122002
India 
Phone  911244647300  
Fax  911244375564   
Email  monisha_sharma@merck.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Monisha Sharma 
Designation  Senior Director- Clinical Research 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54

Gurgaon
HARYANA
122002
India 
Phone  911244647300  
Fax  911244375564   
Email  monisha_sharma@merck.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Monisha Sharma 
Designation  Senior Director- Clinical Research 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54

Gurgaon
HARYANA
122002
India 
Phone  911244647300  
Fax  911244375564   
Email  monisha_sharma@merck.com  
 
Source of Monetary or Material Support  
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc 
 
Primary Sponsor  
Name  Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc 
Address  126 East Lincoln Ave. P.O. Box 2000 Rahway, NJ 07065 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
France
Germany
Ireland
Israel
Italy
Japan
New Zealand
Poland
Republic of Korea
South Africa
Spain
Sweden
Switzerland
Turkey
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sameer Rastogi  All India Institute of Medical Sciences  Room No. 216, 2nd Floor, Dr. B.R.A Institute-Rotary Cancer Hospital; AIIMS, Ansari Nagar, New Delhi - 110029
South
DELHI 		 919958975343

samdoc_mamc@yahoo.com 
Dr Priya Tiwari  Artemis Hospitals  Room Number 1919, Basement, Sector 51, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA 		 911244511111

priya.tiwari@artemishospitals.com 
Dr Prabhat Bhargava  TATA Memorial Hospital  Room No 1115, 11th Floor, Homi Bhabha Block, Dr Ernest Borges Marg, Parel (E), Mumbai 400 012, Maharashtra, India
Mumbai
MAHARASHTRA 		 917276174221

bhargava611@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute Ethics Committee-AIIMS  Approved 
Institutional Ethics Committee_Artemis Health Institute   Approved 
Institutional Ethics Committee_Tata Memorial Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C439||Malignant melanoma of skin, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MK7684A (Vibostolimab with Pembrolizumab)  Dose: Vibostolimab 200 mg + Pembrolizumab 200 mg Frequency: every 3 weeks (Q3W) Route of Administration: intravenous (IV) Duration: 17 Cycles MK-7684A (Vibostolimab 200 mg + Pembrolizumab 200 mg) administered as an intravenous (IV) infusion every 3 weeks (Q3W) per subject per cycle for 17 Cycles. 
Comparator Agent  Pembrolizumab (200 mg)  Dose: Adults: Pembrolizumab 200 mg of drug per subject per cycle Adolescents: ≥40 kg: 2 mg/kg (up to max of 200 mg) of drug per subject per cycle Frequency: Every 3 weeks (Q3W) Route of administration: Intravenous (IV) Duration: 17 Cycles Pembrolizumab 200 mg administered as an intravenous (IV) infusion every 3 weeks (Q3W) 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines.
2. Has not received any prior systemic therapy for melanoma beyond surgical resection.
3. Has had no more than 12 weeks between final surgical resection and randomization.
4. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
5. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.
6. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. 
 
ExclusionCriteria 
Details  1. Has ocular, mucosal, or conjunctival melanoma
2. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
3. Has not adequately recovered from major surgical procedure or has ongoing surgical complications
4. Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
5. Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
6. Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
10. Has an active autoimmune disease that has required systemic treatment in past 2 years
11. Has an active infection requiring systemic therapy
12. Has had an allogenic tissue/solid organ transplant 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
• To compare MK-7684A to pembrolizumab with respect to RFS.
• Hypothesis (H1): MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator. 		 RFS timepoint is event driven up to approximately 56 months. 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare MK-7684A to
pembrolizumab with respect to DMFS.
• Hypothesis (H2): MK-7684A is
superior to pembrolizumab with respect to DMFS as assessed by investigator. 		 DMFS timepoint is event driven up to approximately 72 months. 
• To compare MK-7684A to
pembrolizumab with respect to OS.
• Hypothesis (H3): MK-7684A is
superior to pembrolizumab with respect to overall survival. 		 OS: The time from randomization to death due to any cause. 
To evaluate the safety and tolerability of MK-7684A and pembrolizumab  • Adverse event
• Study intervention discontinuation due to AEs 
To compare MK-7684A to
pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and
role functioning using the EORTC QLQ-C30 		 • Change in score from baseline at a predefined timepoint evaluated by:
o Global health status/QoL score (Items 29 and 30)
o Physical functioning score (Items 1-5)
• Role functioning score (Items 6 and 7) 
 
Target Sample Size   Total Sample Size="1560"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 06/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/01/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="8"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma. 
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