Futibatinib + Pembrolizumab for Endometrial Cancer
Trial Summary
What is the purpose of this trial?
It's propose this pilot phase 2 study to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma to provide a well-tolerated regimen for durable responses.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that you should not be on certain investigational drugs, live vaccines, or strong inhibitors and inducers of CYP3A4 within specific timeframes before starting the study drugs. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drugs Futibatinib and Pembrolizumab for treating endometrial cancer?
Pembrolizumab has shown effectiveness in treating advanced endometrial cancer, especially in patients with specific genetic features like microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. It has been approved for use in these cases, indicating its potential benefit in treating endometrial cancer.12345
What safety information is available for pembrolizumab in endometrial cancer treatment?
How is the drug combination of Futibatinib and Pembrolizumab unique for treating endometrial cancer?
The combination of Futibatinib and Pembrolizumab is unique because it pairs a targeted therapy (Futibatinib) with an immunotherapy (Pembrolizumab), potentially offering a novel approach for endometrial cancer treatment. Pembrolizumab is already used for certain types of endometrial cancer, but combining it with Futibatinib could enhance its effectiveness by targeting different pathways in the cancer cells.12345
Research Team
Siqing fu
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with advanced or metastatic endometrial carcinoma that's microsatellite stable (MSS) and can't be cured by surgery or radiation. They should have tried or declined chemotherapy, have good organ function, no prior anti-PD-(L)1 therapy or FGFR inhibitors, measurable disease per RECIST 1.1 criteria, and not be pregnant while on the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combination therapy of futibatinib and pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Futibatinib
- Pembrolizumab
Futibatinib is already approved in United States for the following indications:
- Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Comprehensive Cancer Network
Collaborator