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Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)

NCT06036836•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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) \[Cohort B\].

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+11 more criteria

Exclusion Criteria

•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)
•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)
+2 more criteria

Locations (44)

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

Key Dates

Start Date

September 29, 2023

Primary Completion Date

March 12, 2026

Completion Date

March 12, 2026

Last Updated

March 19, 2026

Enrollment

163

ACTUAL participants

Conditions

Solid TumorCutaneous Squamous Cell CarcinomaEndometrial Cancer

Interventions

favezelimab/pembrolizumab

BIOLOGICAL

pembrolizumab

BIOLOGICAL

lenvatinib

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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