Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
NCT ID: NCT06036836
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2023-09-29
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Favezelimab/Pembrolizumab
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles.
favezelimab/pembrolizumab
IV infusion
Pembrolizumab
Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles.
pembrolizumab
IV infusion
Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
favezelimab/pembrolizumab
IV infusion
lenvatinib
Oral administration of capsule
Pembrolizumab + Lenvatinib (Cohort B)
Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
pembrolizumab
IV infusion
lenvatinib
Oral administration of capsule
Interventions
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favezelimab/pembrolizumab
IV infusion
pembrolizumab
IV infusion
lenvatinib
Oral administration of capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
* Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
* Is systemic treatment naïve
* Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
* Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent
Cohort B only
* Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
* Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
* Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
* Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
* Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
* Has adequately controlled blood pressure without antihypertensive medication
All Cohorts
* Agrees to follow contraception guidelines if a participant of childbearing potential
* Has a life expectancy \>3 years per investigator assessment
* Has adequate organ function
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
* If positive for hepatitis C, has undetectable viral load at screening
* If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy
Exclusion Criteria
* Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
* History of allogeneic tissue/solid organ transplant
Cohort A only
* Received prior radiotherapy to the index lesion (in-field lesion)
* Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible
Cohort B
* Has had major surgery within 3 weeks prior to first dose of study interventions
* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
* Has urine protein ≥1 g/24 hours
* Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Yale-New Haven Hospital-Yale Cancer Center ( Site 0643)
New Haven, Connecticut, United States
Dana-Farber Cancer Institute ( Site 0642)
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey ( Site 0635)
New Brunswick, New Jersey, United States
Duke Cancer Institute ( Site 0641)
Durham, North Carolina, United States
Cleveland Clinic Main ( Site 0639)
Cleveland, Ohio, United States
St. Luke's University Health Network ( Site 0636)
Bethlehem, Pennsylvania, United States
UPMC Hillman Cancer Center ( Site 0644)
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center-CRO-Simmons Comprehensive Cancer Center ( Site 0645)
Dallas, Texas, United States
St Vincent's Hospital-The Kinghorn Cancer Centre ( Site 0005)
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital ( Site 0008)
St Leonards, New South Wales, Australia
Blacktown Hospital ( Site 0003)
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 0002)
Brisbane, Queensland, Australia
The Alfred Hospital ( Site 0004)
Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0006)
Murdock, Western Australia, Australia
Sunnybrook Research Institute ( Site 0607)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0606)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0602)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0605)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0604)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0153)
Strasbourg, Alsace, France
CENTRE LEON BERARD ( Site 0151)
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 0154)
Brest, Finistere, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0155)
Paris, , France
Universitaetsklinikum Essen ( Site 0185)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0182)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0183)
Dresden, Saxony, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori-SC Oncologia Medica 3 - Tumori Testa-collo ( Site 025
Milan, Lombardy, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
Napoli, , Italy
Hospital Sultan Ismail-Pusat Rawatan Radioterapi Dan Onkologi ( Site 0063)
Johor Bahru, Johor, Malaysia
University Malaya Medical Centre ( Site 0061)
Lembah Pantai, Kuala Lumpur, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 0062)
Kuching, Sarawak, Malaysia
Radboudumc ( Site 0274)
Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum ( Site 0272)
Rotterdam, South Holland, Netherlands
University Medical Center Groningen ( Site 0273)
Groningen, , Netherlands
Taichung Veterans General Hospital-GYNECOLOGY ( Site 0033)
Taichung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0032)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 0031)
Taipei, , Taiwan
Medipol Mega Universite Hastanesi-oncology ( Site 0425)
Stanbul, Istanbul, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 0424)
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0421)
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara-Oncology ( Site 0426)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 0427)
Ankara, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0423)
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-4280A-010
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505022-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-7288
Identifier Type: REGISTRY
Identifier Source: secondary_id
4280A-010
Identifier Type: -
Identifier Source: org_study_id