NCT06041802

A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)

A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MK-3475A in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR).

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab (+) Berahyaluronidase alfa	Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa for SC administration.

Timeline

• Start date: 2023-10-20
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2023-09-18
• Last updated: 2026-02-17

Locations

18 sites across 1 country: Japan