A Phase 2 Study of Setanaxib and Pembrolizumab in Recurrent SCCHN
Research type
Research Study
Full title
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)
IRAS ID
1004322
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Genkyotex Suisse SA
Eudract number
2021-004627-33
ISRCTN Number
ISRCTN63646763
Research summary
Squamous Cell Carcinoma of the Head and Neck is a type of cancer that occurs in the outermost surface of the skin or in certain tissues within the head and neck region including the throat, mouth, sinuses, and nose. This type of cancer comes from particular cells called squamous cells which are found in the outer layer of skin and in the mucous membranes (moist lining of digestive, respiratory, reproductive, and urinary tracts).
The purpose of this research study is to evaluate if setanaxib, a test medicine, is safe and will help in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) when combined with another medication, pembrolizumab, which is already approved and used to treat this sort of cancer. This study is placebo controlled, so participants will receive setanaxib or matching placebo (dummy (tablets in addition to the standard treatment, pembrolizumb. Patients who agree to participate in the study and pass screening will receive pembrolizumab at 3-week intervals as an intravenous infusion together with setanxib or placebo as daily tablets taken by mouth, for a maximum of 2 years or until the cancer had got worse or unacceptable side effects from the treatments are seen. Participants will be followed up for side effects and to monitor changes in their cancer with regular tumour scans, and tumour biopsies will also be performed.
The study will consist of an up to 28-day Screening Period, an up to 24-month Treatment Period (Day 1 to Week 105), and a 28-day Follow-up Period. The entire study will enrol approximately 60 patients, over the age of 18 split into the two treatment groups (Setanaxib vs Matching placebo) and it is expected that the study will last approximately 113 weeks.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0052
Date of REC Opinion
6 May 2022
REC opinion
Further Information Favourable Opinion