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Futibatinib + Pembrolizumab for Endometrial Cancer
Study Summary
This trial is testing a new combination therapy for endometrial cancer that is metastatic and microsatellite stable. The goal is to find a regimen that is well tolerated and leads to durable responses.
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 2021 Phase 1 & 2 trial • 407 Patients • NCT02052778Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I currently have active bleeding or an active stomach ulcer.I have another cancer that needs treatment besides hormone therapy.I still have moderate side effects from previous treatments.I am fully active or can carry out light work.I cannot swallow pills and do not have a feeding tube or receive nutrition through IV.I have an autoimmune disease but only need treatment for skin rash or hormone issues.My kidney function, measured by creatinine levels or clearance, is within the required range.I am not pregnant, can use birth control, and will do so for 180 days after my last dose.I finished any radiation therapy at least 14 days ago and have recovered from its side effects.I have recovered from any major surgeries or significant injuries recently.I haven't had cancer treatment that affects my whole body within the last 3 weeks.I have not received a live vaccine in the last 30 days.I need steroids for uncontrolled brain symptoms despite epilepsy medication.My cancer has spread to the lining of my brain or spinal cord, or to my lymph system.I am currently taking immunosuppressants or steroids higher than 10 mg/day of prednisone.I have HIV and need HAART or have active hepatitis B or C.My advanced endometrial cancer cannot be cured with surgery or radiation, and I have had or declined chemotherapy.My cancer is microsatellite stable, confirmed by a certified lab.I have never been treated with anti-PD-(L)1 or FGFR inhibitor therapies.You have had allergic reactions in the past to the study drugs or any ingredients in them.I can provide recent tissue samples or agree to a biopsy for the study.I can take pills and do not have issues with absorbing medication.I do not have any severe ongoing illnesses or recent major heart issues.I haven't taken strong CYP3A4 drugs in the last 2 weeks.I have significant health issues related to calcium levels or unusual mineral deposits in my body.My organs are functioning well.
- Group 1: pembrolizumab
- Group 2: futibatini
- 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
How many individuals are included in this experiment at most?
"That is correct. The online information on clinicaltrials.gov demonstrates that the study is still looking for 30 individuals at 1 centre."
What are the most common indications for Futibatinib?
"Futibatinib is typically used to treat malignant neoplasms, but it can also help patients with conditions like microsatellite instability high and disease progression after chemotherapy."
Are there any positions still available for those interested in participating in this research?
"The trial, which was initially posted on September 30th 2021, is currently looking for willing participants. The listing was most recently edited on July 31st 2022."
What are the possible dangers associated with Futibatinib?
"Futibatinib's safety is not as well known because it is only in Phase 2 trials. There is some data supporting its safety, but no information on whether or not the drug actually works."
Are there other instances in which Futibatinib has been trialed?
"Presently, 1005 clinical trials are underway that focus on Futibatinib. Out of those ongoing studies, 124 have reached Phase 3. The majority of these research projects are situated in Houston, Texas; though, there are 36268 total locations running trials for this medication globally."
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