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

NCT05323656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-09-02

Study results available
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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

DRUG

Setanaxib

Oral tablets, 400 mg per tablet

BIOLOGICAL

Pembrolizumab

200 mg IV infusion

DRUG

Placebo

Oral tablets

Sponsors & Collaborators

  • Calliditas Therapeutics Suisse SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2024-02-18
Completion
2025-08-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323656 on ClinicalTrials.gov