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Setanaxib + Pembrolizumab for Head and Neck Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have cancer that has spread to my brain or spinal cord.My cancer can be measured and biopsied according to specific guidelines.I am considered for my first treatment with pembrolizumab for my recurring or spreading head/neck cancer.My cancer has returned or spread and cannot be removed by surgery.I have a long-term stomach or bowel condition that causes diarrhea.My tumor biopsy shows a CPS of 1 or more.I have had serious blood disorders needing treatment.My heart condition is stable.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with pembrolizumab before.I know my HPV status.I have HIV or hepatitis B/C.I have never taken setanaxib or been in a setanaxib study before.My tumor has a CAFs level of 5% or higher, confirmed by a recent biopsy.I haven't had monoclonal antibody cancer treatment in the last 4 weeks.I am currently on medication for an infection.I am 18 years old or older.I have no active cancer except for certain skin cancers or treated cancers with no signs for 2 years.I can provide informed consent and follow the study's requirements.I have had surgery or a condition that could affect how my body absorbs medication.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 had chemotherapy, targeted therapy, or radiation (except for bone metastasis) in the last 2 weeks.I am using effective birth control and will continue for 4 months after my last treatment.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.My organs and bone marrow are functioning well, and I haven't had recent transfusions or need ongoing growth factor support.I am not on high-dose steroids or other drugs that weaken my immune system.
- Group 1: Setanaxib 800 mg and Pembrolizumab 200 mg
- Group 2: Placebo and Pembrolizumab 200 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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