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

NCT ID: NCT04601857

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2025-09-16

Brief Summary

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.

Conditions

Advanced and Metastatic Urothelial Cancer

Keywords

Futibatinib; Pembrolizumab; Urothelial cancer; FGFR; TAS120; MK3475 B04

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.

Group Type: EXPERIMENTAL

Futibatinib

Intervention Type: DRUG

Oral

Pembrolizumab

Intervention Type: DRUG

IV

Cohort B

Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.

Group Type: EXPERIMENTAL

Futibatinib

Intervention Type: DRUG

Oral

Pembrolizumab

Intervention Type: DRUG

IV

Interventions

Futibatinib

Oral

Intervention Type: DRUG

Pembrolizumab

IV

Intervention Type: DRUG

Other Intervention Names

TAS120; KEYTRUDA; MK-3475-B04

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide written informed consent for the trial.

2. Age ≥ 18 years of age

3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.

1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.

2. Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type [non-mutated] tumors)

4. Unfit for or intolerant to standard platinum-based chemotherapy.

5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

6. Adequate organ function.

7. Have a measurable disease per RECIST 1.1

Exclusion Criteria

1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.

2. History and/or current evidence of any of the following disorders:

1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.

2. Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.

3. Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.

3. Has received a live vaccine within 30 days prior to the first dose of study drug.

4. Have an active autoimmune disease that has required systemic treatment in the past 2 years.

5. Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.

6. Have had an allogenic tissue/ organ transplant.

7. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.

8. Have known active central nervous system metastases and/or carcinomatous meningitis.

9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Comprehensive Care Centers of Nevada

Las Vegas, Nevada, United States

ICANS - Institut de cancérologie de Strasbourg Europe

Strasbourg, Bas-Rhin, France

Institut Paoli Calmettes - Hôpital de jour

Marseille, Bouches-du-Rhône, France

Centre Georges-François Leclerc

Dijon, Côte d'Or, France

Centre Leon Berard - departement d'oncologie medicale

Lyon, Rhone, France

Centre Regional de Lutte Contre le Cancer de Lorraine

Vandœuvre-lès-Nancy, , France

Institut De Cancerologie Gustave Roussy

Villejuif, , France

ALTHAIA, Xarxa Assistencial Universitària de Manresa

Manresa, Brcelona, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d'Hebrón

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario HMN Sanchinarro

Madrid, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital la Fe

Valencia, , Spain

Countries

United States; France; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000945-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAS-120-203

Identifier Type: -

Identifier Source: org_study_id