A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability, and Effects on Tumour Biomarkers of the NOX1/4 Inhibitor Setanaxib, when Administered with the PD-1 Inhibitor Pembrolizumab, in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509917-35-00

Acronym

GSN000400

Enrollment

Registered

2024-05-17

Start date

2022-03-21

Completion date

2025-08-21

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Brief summary

Best percentage change in tumour size, defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1

Detailed description

PFS, defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 3, 6, and 12 months and median PFS will be summarised, Change from Baseline in CAFs level in tumour tissue, Change from Baseline in the number of CD8+ TILs and regulatory T-cells in tumour tissue

Interventions

DRUGSetanaxib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPlacebo tablets setanaxib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Best percentage change in tumour size, defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1	—

Secondary

Measure	Time frame
PFS, defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 3, 6, and 12 months and median PFS will be summarised, Change from Baseline in CAFs level in tumour tissue, Change from Baseline in the number of CD8+ TILs and regulatory T-cells in tumour tissue	—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026