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

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.

Timeline

Start

2022-04-06

Primary completion

2024-02-18

Completion

2025-08-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Setanaxib 1600 mg and Pembrolizumab 200 mg; p = 0.7008; LS Mean Difference 5.05 (80% CI -11.98 to 22.0); ANCOVA NCT05323656 ↗

Drugs

Indications