Setanaxib + Pembrolizumab for Head and Neck Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Genkyotex Suisse SA

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests setanaxib and pembrolizumab in patients with head and neck cancer that has returned or spread. Setanaxib may stop cancer growth, and pembrolizumab helps the immune system fight cancer. Pembrolizumab is now used for various cancers including head and neck cancer.

Eligibility Criteria

Adults with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are candidates for first-line pembrolizumab treatment. They must have adequate organ function, known HPV status, measurable disease per RECIST v1.1, a life expectancy over 6 months, and an ECOG performance status of 0 or 1. Women must use effective contraception and have a negative pregnancy test; men should also agree to use contraception.

Inclusion Criteria

My cancer can be measured and biopsied according to specific guidelines.

My cancer has returned or spread and cannot be removed by surgery.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

I have a long-term stomach or bowel condition that causes diarrhea.

I have had serious blood disorders needing treatment.

My heart condition is stable.

I have been treated with pembrolizumab before.

I have HIV or hepatitis B/C.

I have never taken setanaxib or been in a setanaxib study before.

I am currently on medication for an infection.

I can provide informed consent and follow the study's requirements.

I am legally unable to make my own decisions.

I have recovered from side effects of previous treatments, except for hair loss.

I haven't taken strong medication that affects liver enzymes in the last 21 days.

I have an autoimmune disease that needed treatment in the last 3 months.

Treatment Details

The trial is testing the effectiveness of Setanaxib combined with Pembrolizumab versus a placebo with Pembrolizumab in shrinking tumors according to RECIST v1.1 criteria in patients with SCCHN. Participants will be randomly assigned to either receive Setanaxib or a placebo alongside standard Pembrolizumab therapy.

2Treatment groups

Experimental Treatment

Active Control

Group I: Setanaxib 800 mg and Pembrolizumab 200 mgExperimental Treatment2 Interventions

Participants will be administered Setanaxib 800 mg twice daily. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Group II: Placebo and Pembrolizumab 200 mgActive Control2 Interventions

Participants will be administered placebo throughout the 24 month treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: