Futibatinib + Pembrolizumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Taiho Oncology, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.

Eligibility Criteria

Adults with advanced or metastatic urothelial carcinoma who can't have platinum-based chemo are eligible. They must be in good physical condition (ECOG PS 0-1), have proper organ function, and measurable disease. Cohort A requires an FGFR3 mutation or FGFR1-4 fusion; Cohort B includes all other patients. Exclusions include significant non-tumor related health issues, recent live vaccines, active autoimmune diseases requiring treatment within 2 years, certain infections like HIV/Hepatitis B/C, prior anti-PD-1/L1/L2 or FGFR inhibitor therapy.

Inclusion Criteria

I am 18 years old or older.

I cannot tolerate or am not suitable for standard platinum-based chemotherapy.

I can carry out all my usual activities without help.

My cancer has an FGFR3 mutation or an FGFR1-4 fusion.

My bladder cancer is advanced or has spread, and I haven't had systemic treatment for it.

Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

I have had pneumonitis treated with steroids or have it now.

I have HIV or a history of Hepatitis B or C.

I have received an organ or tissue transplant from another person.

I have an immune system disorder or am on long-term steroids.

I have been treated with medications targeting PD-1, PD-L1/L2, or FGFR.

I have cancer that has spread to my brain or surrounding membranes.

Participant Groups

The trial is testing the combination of futibatinib (an FGFR inhibitor) and pembrolizumab (a PD-1 antibody) for their effectiveness and safety in treating urothelial cancer when standard chemotherapy isn't suitable.

2Treatment groups

Experimental Treatment

Group I: futibatinib and pembrolizumab (Cohort B)Experimental Treatment1 Intervention

All other patients than in Cohort A with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type \[non-mutated\] tumors).

Group II: futibatinib and pembrolizumab (Cohort A)Experimental Treatment1 Intervention

Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.

Futibatinib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Lytgobi for:

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