NCT04220866

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 Carcinoma (HNSCC) (MK-1454-002)

A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy

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

Summary

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag 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.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Type	Name	Description
DRUG	Ulevostinag	IT injection
BIOLOGICAL	Pembrolizumab	IV infusion

Timeline

• Start date: 2020-03-04
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-01-07
• Last updated: 2025-10-29
• Results posted: 2023-10-27

Locations

34 sites across 10 countries: United States, Australia, Austria, Brazil, France, Israel, Norway, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study