At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
Setanaxib +2 moredrug
Likely dose
Setanaxib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Setanaxib, Pembrolizumab, and 1 other intervention for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 55 participants across 24 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of Head and Neck
CountriesFrance, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartApr 2022
First PostedApr 2022
Primary CompletionFeb 2024
Study CompletionAug 2025
TodayJul 2026
First PostedApr 12, 2022
Enrollment StartApr 6, 2022
Primary CompletionFeb 18, 2024
Study CompletionAug 21, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.2 years ago
Interventions
Setanaxibdrug
Oral tablets, 400 mg per tablet
Pembrolizumabbiological
200 mg IV infusion
Placebodrug
Oral tablets