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Monoclonal Antibodies

Setanaxib + Pembrolizumab for Head and Neck Cancer

Phase 2
Waitlist Available
Research Sponsored by Genkyotex Suisse SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease, in accordance with RECIST v1.1, and with tumour accessible and of sufficient volume for pre-treatment and on-treatment biopsy
Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or metastatic with or without nodal involvement, and with or without metastatic spread, and is not eligible for surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 26 months
Awards & highlights

Study Summary

This trial is testing setanaxib as a possible treatment for people with cancer that has come back or spread to other parts of the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues like diarrhea, changes in blood tests reflecting liver and kidney function, potential impact on bone marrow leading to lower blood cell counts which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured and biopsied according to specific guidelines.
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My cancer has returned or spread and cannot be removed by surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Percentage Change in Tumour Size
Secondary outcome measures
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of Setanaxib
Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue
+17 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setanaxib
2020
Completed Phase 1
~70
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Genkyotex Suisse SALead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Calliditas Therapeutics Suisse SALead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05323656 — Phase 2
Oral Squamous Cell Carcinoma Research Study Groups: Setanaxib 800 mg and Pembrolizumab 200 mg, Placebo and Pembrolizumab 200 mg
Oral Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05323656 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323656 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this project is actively seeking applicants. Initially posted on April 6th 2022 and last modified October 24th 2022, the trial seeks 50 participants across 5 sites."

Answered by AI

Has Setanaxib been granted official authorization by the FDA?

"There is limited evidence of safety for Setanaxib, leading our team to give it a score of 2. No data in regards to efficacy has been provided yet."

Answered by AI

Is there still capacity for enrolment in this investigation?

"This study is actively searching for participants; the initial posting was on April 6th 2022 and data was most recently updated October 24th of this year."

Answered by AI

In what locales is this clinical test currently taking place?

"There are 5 recruiting sites that have been approved to take part in the trial: Siteman Cancer Center - St. Peters, Washington University School of Medicine Center for Advanced Medicine, Siteman Cancer Center - North County and two additional medical facilities."

Answered by AI
~2 spots leftby May 2024