Melanoma Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

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

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 is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1560

Study ID:

NCT05665595

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 51 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
Los Angeles California, 90025, United States More Info
Study Coordinator
Contact
310-231-2153
UCSF Medical Center at Mission Bay ( Site 0130)
San Francisco California, 94158, United States More Info
Study Coordinator
Contact
415-353-7392
Comprehensive Cancer Centers of Nevada ( Site 0142)
Las Vegas Nevada, 89169, United States More Info
Study Coordinator
Contact
702-952-1242
The West Clinic, PLLC dba West Cancer Center ( Site 0119)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina More Info
Study Coordinator
Contact
54111531493950
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
Buenos Aires Caba, C1431, Argentina More Info
Study Coordinator
Contact
5411529901002543
Instituto de Oncología de Rosario ( Site 0206)
Rosario Santa Fe, S2000, Argentina More Info
Study Coordinator
Contact
54 9 341 5778394
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
Blacktown New South Wales, 2148, Australia More Info
Study Coordinator
Contact
61298455200
Calvary Mater Newcastle-Medical Oncology ( Site 1462)
Waratah New South Wales, 2298, Australia More Info
Study Coordinator
Contact
61249211561
Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
Wollstonecraft New South Wales, 2065, Australia More Info
Study Coordinator
Contact
61299117336
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane Queensland, 4029, Australia More Info
Study Coordinator
Contact
61736464311
Gallipoli Medical Research Foundation-GMRF CTU ( Site 1451)
Brisbane Queensland, 4120, Australia More Info
Study Coordinator
Contact
+61448632604
Cairns Hospital-Clinical Research Unit ( Site 1458)
Cairns Queensland, 4870, Australia More Info
Study Coordinator
Contact
61499200998
Tasman Oncology Research ( Site 1456)
Southport Queensland, 4215, Australia More Info
Study Coordinator
Contact
+61 7 5613 2480
Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
Adelaide South Australia, 5000, Australia More Info
Study Coordinator
Contact
61870745559
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
Melbourne Victoria, 3000, Australia More Info
Study Coordinator
Contact
+6138559500
One Clinical Research ( Site 1460)
Nedlands Western Australia, 6009, Australia More Info
Study Coordinator
Contact
0410565868
Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
Passo Fundo Rio Grande Do Sul, 99010, Brazil More Info
Study Coordinator
Contact
555421033490
ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
Lages Santa Catarina, 88501, Brazil More Info
Study Coordinator
Contact
4933805200
Oncocentro Valdivia ( Site 0307)
Valdivia Los Rios, 51121, Chile More Info
Study Coordinator
Contact
+56992195434
FALP-UIDO ( Site 0303)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
56224457254
Oncovida ( Site 0304)
Santiago Region M. De Santiago, 75100, Chile More Info
Study Coordinator
Contact
56986303096
Clínica UC San Carlos de Apoquindo ( Site 0305)
Santiago Region M. De Santiago, 76200, Chile More Info
Study Coordinator
Contact
56223546919
Bradfordhill-Clinical Area ( Site 0302)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56 9 84859580
ONCOCENTRO APYS-ACEREY ( Site 0300)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Centro de Investigación Oncológica del Norte ( Site 0308)
Antofagasta , 12400, Chile More Info
Study Coordinator
Contact
56994198125
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
Beijing Beijing, 10014, China More Info
Study Coordinator
Contact
8613911233048
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
Wuhan Hubei, 43002, China More Info
Study Coordinator
Contact
15807183251
Emek Medical Center-oncology ( Site 0952)
Afula , 18341, Israel More Info
Study Coordinator
Contact
97246495723
Soroka Medical Center ( Site 0953)
Be'er Sheva , 84101, Israel More Info
Study Coordinator
Contact
97286400797
Rambam Health Care Campus-Oncology Division ( Site 0955)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247776700
Hadassah Medical Center ( Site 0951)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
972505172537
Rabin Medical Center-Oncology ( Site 0954)
Petah Tikva , 49414, Israel More Info
Study Coordinator
Contact
+972-3-9378077
Sheba Medical Center-ONCOLOGY ( Site 0950)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
97235302243
Niigata Cancer Center Hospital ( Site 1751)
Niigata-shi Niigata, 951-8, Japan More Info
Study Coordinator
Contact
81252665111
Seoul National University Hospital-Oncology ( Site 1600)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
82220724035
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
82222288138
Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
+82-2-3410-6820
Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
Tauranga Bay Of Plenty, 3112, New Zealand More Info
Study Coordinator
Contact
6475798153
New Zealand Clinical Research (Christchurch) ( Site 1509)
Christchurch Canterbury, 8011, New Zealand More Info
Study Coordinator
Contact
6433640020
P3 Research - Palmerston North ( Site 1510)
Palmerston North Manawatu-Wanganui, 4414, New Zealand More Info
Study Coordinator
Contact
6463508130
Harbour Cancer & Wellness ( Site 1508)
Auckland , 0627, New Zealand More Info
Study Coordinator
Contact
+6421783590
University Hospital Basel ( Site 1303)
Basel Basel-Stadt, 4031, Switzerland More Info
Study Coordinator
Contact
+41 61 32 8 60 16
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
Genève Geneve, 1205, Switzerland More Info
Study Coordinator
Contact
0041223729862
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
st.Gallen Sankt Gallen, 9007, Switzerland More Info
Study Coordinator
Contact
41714941111
Ospedale Regionale Bellinzona e Valli ( Site 1308)
Bellinzona Ticino, 6500, Switzerland More Info
Study Coordinator
Contact
00418119411
CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
Lausanne Vaud, 1011, Switzerland More Info
Study Coordinator
Contact
41795562698
Hôpital de Sion ( Site 1305)
Sion Wallis, 1951, Switzerland More Info
Study Coordinator
Contact
41795567881
UniversitätsSpital Zürich-Dermatology ( Site 1300)
Zürich Flughafen Zurich, 8058, Switzerland More Info
Study Coordinator
Contact
41442552588
Ankara City Hospital-Medical Oncology ( Site 1357)
Cankaya Ankara, 06800, Turkey More Info
Study Coordinator
Contact
00905052933234
Hacettepe Universite Hastaneleri ( Site 1363)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
905326880089

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1560

Study ID:

NCT05665595

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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