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Olaparib + Pembrolizumab + Carboplatin for Head and Neck Cancer
Study Summary
This trial will test a new treatment for head and neck cancer that could be more effective than the standard of care.
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.Trial Design
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Who is running the clinical trial?
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- I am not planning to become pregnant or father a child during the study and for 120 days after.My kidney function, measured by creatinine levels or clearance, is within the required range.My recent tests show my bone marrow and organs are functioning well.I haven't needed strong medication for an autoimmune disease in the last 2 years.My blood clotting tests are within normal limits, or if on blood thinners, within the therapeutic range.I will use a condom during treatment and for 3 months after, and my partner will use contraception if she can have children.I am not currently using strong or moderate drugs that affect liver enzymes.I have had an organ or stem cell transplant.I have been cancer-free for 2 years, except for certain low-risk types or skin cancer.I have been treated with drugs targeting immune checkpoints.I am not currently taking strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.You have received any experimental treatment within the past 28 days.I have no allergies to olaparib, pembrolizumab, carboplatin, or similar drugs.I have not received any live vaccines in the last 30 days.I had major surgery more than 2 weeks ago and have recovered from it.I have a serious health condition that is not under control.I cannot swallow pills or have a stomach condition that affects medication absorption.My cancer is a type of head and neck cancer that has returned or spread.My disease cannot be cured or I am not eligible for local treatments.I have a history of Hepatitis B or active Hepatitis C.I have an active tuberculosis infection.My throat cancer is known to express p16.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.My cancer can be measured by scans or physical exam.I am postmenopausal or not pregnant.I am fully active and can carry on all my pre-disease activities without restriction.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions or erythropoietin.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I am 18 years old or older.My cancer worsened within 6 months after treatment meant to cure it.I have received treatment for cancer that came back or spread.I have or had lung inflammation that needed steroids.My cancer has spread to my brain or spinal cord.
- Group 1: Olaparib + Pembrolizumab + Carboplatin AUC
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any patients who have not yet been enrolled in this research project?
"The information available on clinicaltrials.gov suggests that this trial is still recruiting patients. This research project was initially advertised on August 7th, 2021 and has since been updated October 18th, 2022. They are looking for 30 individuals to participate at 1 site."
How many individuals are being monitored in this clinical trial?
"That is correct, the trial information available on clinicaltrials.gov shows that this study is still open for enrollment. This particular trial was first posted on 8/7/2021 and was last edited on 10/18/2022. The goal is to have 30 patients enrolled from 1 site."
What is the extent of research on Olaparib's effects?
"At this time, there are a total of 1755 clinical trials underway for Olaparib. Of these active studies, 333 have reached Phase 3 testing. The largest number of trial locations for Olaparib are in Shanghai, but there are 78412 sites running trials globally."
What are the potential risks associated with Olaparib use?
"At the moment, Olaparib has only been proven safe in Phase 2 trials. Therefore, it receives a score of 2."
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