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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05665595




Registration number
NCT05665595
Ethics application status
Date submitted
16/12/2022
Date registered
27/12/2022
Date last updated
22/05/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
MK-7684A-010
Secondary ID [2] 0 0
7684A-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pembrolizumab/Vibostolimab
Other interventions - Pembrolizumab

Experimental: Pembrolizumab/Vibostolimab - 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).

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).


Other interventions: Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations

Other interventions: Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS)
Timepoint [1] 0 0
Up to approximately 52 months
Secondary outcome [1] 0 0
Distant Metastasis-Free Survival (DMFS)
Timepoint [1] 0 0
Up to approximately 68 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 96 months
Secondary outcome [3] 0 0
Number of Participants Who Experienced at Least One Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 15 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [4] 0 0
Up to approximately 12 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline and up to approximately 72 months
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Timepoint [6] 0 0
Baseline and up to approximately 72 months
Secondary outcome [7] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Timepoint [7] 0 0
Baseline and up to approximately 72 months

Eligibility
Key inclusion criteria
- 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2031
Actual
Sample size
Target
Accrual to date
Final
1594
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464) - Blacktown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle-Medical Oncology ( Site 1462) - Waratah
Recruitment hospital [3] 0 0
Melanoma Institute Australia-Clinical Trials Unit ( Site 1450) - Wollstonecraft
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [5] 0 0
Cairns Hospital-Clinical Research Unit ( Site 1458) - Cairns
Recruitment hospital [6] 0 0
Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451) - Greenslopes
Recruitment hospital [7] 0 0
Tasman Oncology Research ( Site 1456) - Southport
Recruitment hospital [8] 0 0
Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457) - Adelaide
Recruitment hospital [9] 0 0
Icon Cancer Centre Hobart ( Site 1465) - Hobart
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455) - Melbourne
Recruitment hospital [11] 0 0
One Clinical Research ( Site 1460) - Nedlands
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2148 - Blacktown
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2298 - Waratah
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2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4870 - Cairns
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4120 - Greenslopes
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4215 - Southport
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5000 - Adelaide
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7000 - Hobart
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05665595
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries