Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

Completed · Phase 2

Conditions studied: Solid Tumor, Cutaneous Squamous Cell Carcinoma, Endometrial Cancer

In brief

The purpose of this study is to evaluate pathologic complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) \[Cohort A\] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) \[Cohort B\].

Key facts

Study ID

NCT06036836

Run by

Merck Sharp & Dohme LLC

People needed

163

Starts

2023-09-29

Expected to finish

2026-03-12

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort A only
• 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

You may not qualify if…

• All Cohorts
• 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

Where it is running

• Royal North Shore Hospital ( Site 0008) — St Leonards, New South Wales, Australia
• 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
• 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

Full record on ClinicalTrials.gov

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