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)
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|ClinicalTrials.gov Identifier: NCT05665595|
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : May 31, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Pembrolizumab/Vibostolimab Biological: Pembrolizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||January 19, 2023|
|Estimated Primary Completion Date :||October 22, 2027|
|Estimated Study Completion Date :||March 31, 2031|
Participants receive 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).
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Other Name: MK-7684A
Active Comparator: Pembrolizumab
Adult participants receive 200 mg and adolescent participants ≥40 kg receive 2 mg/kg (up to a max of 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).
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
- Recurrence-Free Survival (RFS) [ Time Frame: Up to approximately 56 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 will be reported for all randomized participants.
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to approximately 72 months ]DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. The DMFS as assessed by the investigator will be reported for all randomized participants.
- Overall Survival (OS) [ Time Frame: Up to approximately 96 months ]OS is defined as the time from randomization to death due to any cause.
- Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to approximately 15 months ]An 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.
- Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 12 months ]An 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.
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score [ Time Frame: Baseline and up to approximately 72 months ]The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.
- Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score [ Time Frame: Baseline and up to approximately 72 months ]The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
- Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score [ Time Frame: Baseline and up to approximately 72 months ]The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
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|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Has not received any prior systemic therapy for melanoma beyond surgical resection
- Has had no more than 12 weeks between final surgical resection and randomization
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
- 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
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Has ocular, mucosal, or conjunctival melanoma
- 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
- Has not adequately recovered from major surgical procedure or has ongoing surgical complications
- Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
- Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has had an allogenic tissue/solid organ transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05665595
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
MK-7684A-010 ( Other Identifier: Merck )
KEYVIBE-010 ( Other Identifier: Merck )
2022-501417-31-00 ( Registry Identifier: EU CT )
jRCT2031230099 ( Registry Identifier: jRCT )
|First Posted:||December 27, 2022 Key Record Dates|
|Last Update Posted:||May 31, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Programmed Cell Death-1 (PD1, PD-1)
T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT)
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action