NCT06036836

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) \[Cohort B\].

Conditions

• Solid Tumor
• Cutaneous Squamous Cell Carcinoma
• Endometrial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	favezelimab/pembrolizumab	IV infusion
BIOLOGICAL	pembrolizumab	IV infusion
DRUG	lenvatinib	Oral administration of capsule

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-03-12
• Completion: 2026-03-12
• First posted: 2023-09-14
• Last updated: 2026-03-19

Locations

44 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, Malaysia, Netherlands, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study