Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05665595
Ethics application status
Date submitted
16/12/2022
Date registered
27/12/2022

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
Treatment: Other - Pembrolizumab/Vibostolimab
Treatment: Other - 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).


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

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

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS)
Timepoint [1] 0 0
Up to approximately 13 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 92 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
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
North Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Caba
Country [20] 0 0
Argentina
State/province [20] 0 0
Santa Fe
Country [21] 0 0
Austria
State/province [21] 0 0
Niederosterreich
Country [22] 0 0
Austria
State/province [22] 0 0
Oberosterreich
Country [23] 0 0
Austria
State/province [23] 0 0
Steiermark
Country [24] 0 0
Austria
State/province [24] 0 0
Tirol
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Belgium
State/province [27] 0 0
Antwerpen
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruxelles-Capitale, Region De
Country [29] 0 0
Belgium
State/province [29] 0 0
Limburg
Country [30] 0 0
Belgium
State/province [30] 0 0
Namur
Country [31] 0 0
Belgium
State/province [31] 0 0
Oost-Vlaanderen
Country [32] 0 0
Belgium
State/province [32] 0 0
Vlaams-Brabant
Country [33] 0 0
Brazil
State/province [33] 0 0
Minas Gerais
Country [34] 0 0
Brazil
State/province [34] 0 0
Parana
Country [35] 0 0
Brazil
State/province [35] 0 0
Rio Grande Do Sul
Country [36] 0 0
Brazil
State/province [36] 0 0
Santa Catarina
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Chile
State/province [39] 0 0
Los Rios
Country [40] 0 0
Chile
State/province [40] 0 0
Region M. De Santiago
Country [41] 0 0
Chile
State/province [41] 0 0
Valparaiso
Country [42] 0 0
Chile
State/province [42] 0 0
Antofagasta
Country [43] 0 0
China
State/province [43] 0 0
Beijing
Country [44] 0 0
China
State/province [44] 0 0
Chongqing
Country [45] 0 0
China
State/province [45] 0 0
Fujian
Country [46] 0 0
China
State/province [46] 0 0
Guangdong
Country [47] 0 0
China
State/province [47] 0 0
Guangxi
Country [48] 0 0
China
State/province [48] 0 0
Hebei
Country [49] 0 0
China
State/province [49] 0 0
Henan
Country [50] 0 0
China
State/province [50] 0 0
Hubei
Country [51] 0 0
China
State/province [51] 0 0
Hunan
Country [52] 0 0
China
State/province [52] 0 0
Jiangsu
Country [53] 0 0
China
State/province [53] 0 0
Jiangxi
Country [54] 0 0
China
State/province [54] 0 0
Jilin
Country [55] 0 0
China
State/province [55] 0 0
Shanghai
Country [56] 0 0
China
State/province [56] 0 0
Shanxi
Country [57] 0 0
China
State/province [57] 0 0
Sichuan
Country [58] 0 0
China
State/province [58] 0 0
Tianjin
Country [59] 0 0
China
State/province [59] 0 0
Xinjiang
Country [60] 0 0
China
State/province [60] 0 0
Yunnan
Country [61] 0 0
China
State/province [61] 0 0
Zhejiang
Country [62] 0 0
Colombia
State/province [62] 0 0
Antioquia
Country [63] 0 0
Colombia
State/province [63] 0 0
Distrito Capital De Bogota
Country [64] 0 0
Colombia
State/province [64] 0 0
Tolima
Country [65] 0 0
Colombia
State/province [65] 0 0
Valle Del Cauca
Country [66] 0 0
France
State/province [66] 0 0
Drome
Country [67] 0 0
France
State/province [67] 0 0
Loire-Atlantique
Country [68] 0 0
France
State/province [68] 0 0
Nord-Pas-de-Calais
Country [69] 0 0
France
State/province [69] 0 0
Provence-Alpes-Cote-d Azur
Country [70] 0 0
France
State/province [70] 0 0
Pyrenees-Atlantiques
Country [71] 0 0
France
State/province [71] 0 0
Rhone
Country [72] 0 0
France
State/province [72] 0 0
Val-de-Marne
Country [73] 0 0
France
State/province [73] 0 0
Paris
Country [74] 0 0
Germany
State/province [74] 0 0
Baden-Wurttemberg
Country [75] 0 0
Germany
State/province [75] 0 0
Bayern
Country [76] 0 0
Germany
State/province [76] 0 0
Niedersachsen
Country [77] 0 0
Germany
State/province [77] 0 0
Nordrhein-Westfalen
Country [78] 0 0
Germany
State/province [78] 0 0
Sachsen
Country [79] 0 0
Germany
State/province [79] 0 0
Schleswig-Holstein
Country [80] 0 0
Germany
State/province [80] 0 0
Berlin
Country [81] 0 0
Germany
State/province [81] 0 0
Hamburg
Country [82] 0 0
India
State/province [82] 0 0
Delhi
Country [83] 0 0
India
State/province [83] 0 0
Haryana
Country [84] 0 0
India
State/province [84] 0 0
Maharashtra
Country [85] 0 0
Ireland
State/province [85] 0 0
Dublin
Country [86] 0 0
Israel
State/province [86] 0 0
Afula
Country [87] 0 0
Israel
State/province [87] 0 0
Be'er Sheva
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Jerusalem
Country [90] 0 0
Israel
State/province [90] 0 0
Petah Tikva
Country [91] 0 0
Israel
State/province [91] 0 0
Ramat Gan
Country [92] 0 0
Italy
State/province [92] 0 0
Emilia-Romagna
Country [93] 0 0
Italy
State/province [93] 0 0
Lombardia
Country [94] 0 0
Italy
State/province [94] 0 0
Puglia
Country [95] 0 0
Italy
State/province [95] 0 0
Sicilia
Country [96] 0 0
Italy
State/province [96] 0 0
Toscana
Country [97] 0 0
Italy
State/province [97] 0 0
Umbria
Country [98] 0 0
Italy
State/province [98] 0 0
Milano
Country [99] 0 0
Italy
State/province [99] 0 0
Modena
Country [100] 0 0
Italy
State/province [100] 0 0
Napoli
Country [101] 0 0
Japan
State/province [101] 0 0
Aichi
Country [102] 0 0
Japan
State/province [102] 0 0
Hokkaido
Country [103] 0 0
Japan
State/province [103] 0 0
Niigata
Country [104] 0 0
Japan
State/province [104] 0 0
Shizuoka
Country [105] 0 0
Japan
State/province [105] 0 0
Tokyo
Country [106] 0 0
Japan
State/province [106] 0 0
Osaka
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Seoul
Country [108] 0 0
New Zealand
State/province [108] 0 0
Bay Of Plenty
Country [109] 0 0
New Zealand
State/province [109] 0 0
Canterbury
Country [110] 0 0
New Zealand
State/province [110] 0 0
Manawatu-Wanganui
Country [111] 0 0
New Zealand
State/province [111] 0 0
Otago
Country [112] 0 0
New Zealand
State/province [112] 0 0
Auckland
Country [113] 0 0
Poland
State/province [113] 0 0
Kujawsko-pomorskie
Country [114] 0 0
Poland
State/province [114] 0 0
Malopolskie
Country [115] 0 0
Poland
State/province [115] 0 0
Mazowieckie
Country [116] 0 0
Poland
State/province [116] 0 0
Podlaskie
Country [117] 0 0
Poland
State/province [117] 0 0
Pomorskie
Country [118] 0 0
Poland
State/province [118] 0 0
Slaskie
Country [119] 0 0
Poland
State/province [119] 0 0
Swietokrzyskie
Country [120] 0 0
Poland
State/province [120] 0 0
Wielkopolskie
Country [121] 0 0
Poland
State/province [121] 0 0
Zachodniopomorskie
Country [122] 0 0
South Africa
State/province [122] 0 0
Eastern Cape
Country [123] 0 0
South Africa
State/province [123] 0 0
Gauteng
Country [124] 0 0
South Africa
State/province [124] 0 0
Kwazulu-Natal
Country [125] 0 0
South Africa
State/province [125] 0 0
Western Cape
Country [126] 0 0
Spain
State/province [126] 0 0
Barcelona
Country [127] 0 0
Spain
State/province [127] 0 0
Gipuzkoa
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid, Comunidad De
Country [129] 0 0
Spain
State/province [129] 0 0
Malaga
Country [130] 0 0
Spain
State/province [130] 0 0
Valenciana, Comunitat
Country [131] 0 0
Spain
State/province [131] 0 0
Sevilla
Country [132] 0 0
Sweden
State/province [132] 0 0
Jonkopings Lan
Country [133] 0 0
Sweden
State/province [133] 0 0
Stockholms Lan
Country [134] 0 0
Switzerland
State/province [134] 0 0
Basel-Stadt
Country [135] 0 0
Switzerland
State/province [135] 0 0
Berne
Country [136] 0 0
Switzerland
State/province [136] 0 0
Geneve
Country [137] 0 0
Switzerland
State/province [137] 0 0
Ticino
Country [138] 0 0
Switzerland
State/province [138] 0 0
Vaud
Country [139] 0 0
Switzerland
State/province [139] 0 0
Wallis
Country [140] 0 0
Switzerland
State/province [140] 0 0
Zurich
Country [141] 0 0
Switzerland
State/province [141] 0 0
Sankt Gallen
Country [142] 0 0
Turkey
State/province [142] 0 0
Ankara
Country [143] 0 0
Turkey
State/province [143] 0 0
Izmir
Country [144] 0 0
Turkey
State/province [144] 0 0
Antalya
Country [145] 0 0
Turkey
State/province [145] 0 0
Istanbul
Country [146] 0 0
Turkey
State/province [146] 0 0
Mersin
Country [147] 0 0
Turkey
State/province [147] 0 0
Samsun
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambridgeshire
Country [149] 0 0
United Kingdom
State/province [149] 0 0
England
Country [150] 0 0
United Kingdom
State/province [150] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05665595