Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Futibatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

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).

Patients will receive futibatinib at an oral dose of 20 mg daily and pembrolizumab at an intravenous dose of 200 mg every 3 weeks

futibatinib and pembrolizumab (KEYTRUDA®))

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.

Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma

A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma

Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR).

DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.

DOR defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

PFS defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first.

OS defined as the time from the date of the first dose to the death date.

Safety and tolerability of the futibatinib and pembolizumab combination therapy based on reported AEs, graded according to the NCI-CTCAE, Version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma	NCT04601857	Advanced and Me...	futibatinib and...	18 Years -	Taiho Oncology, Inc.
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma	NCT04601857	Advanced and Me...	futibatinib and...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for advanced and metastatic urothelial cancer