NCT05323656

A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Calliditas Therapeutics Suisse SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Setanaxib	Oral tablets, 400 mg per tablet
BIOLOGICAL	Pembrolizumab	200 mg IV infusion
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2022-04-06
• Primary completion: 2024-02-18
• Completion: 2025-08-21
• First posted: 2022-04-12
• Last updated: 2025-09-02
• Results posted: 2025-05-09

Locations

24 sites across 7 countries: United States, France, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study