Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcino

• Status: Active, not recruiting
• Trial end date: 2023-04-17

Summary

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag in PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone:

1. in participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and

2. in participants with a tumor that has a PD-L1 CPS ≥ 20.

• Phase: Phase 2

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab