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Bladder cancer drug combo trial halted early

NCT ID NCT04601857

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, futibatinib and pembrolizumab, in 43 people with advanced or metastatic bladder cancer who could not receive standard chemotherapy. The goal was to see if the combo could shrink tumors and to check its safety. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

43 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced and metastatic urothelial cancer

Contacts and locations

Locations

  • ALTHAIA, Xarxa Assistencial Universitària de Manresa

    Manresa, Brcelona, 8243, Spain

  • Centre Georges-François Leclerc

    Dijon, Côte d'Or, 21079, France

  • Centre Leon Berard - departement d'oncologie medicale

    Lyon, Rhone, 69373, France

  • Centre Regional de Lutte Contre le Cancer de Lorraine

    Vandœuvre-lès-Nancy, 54500, France

  • Comprehensive Care Centers of Nevada

    Las Vegas, Nevada, 89148, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario HMN Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 8035, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8025, Spain

  • Hospital la Fe

    Valencia, 46026, Spain

  • ICANS - Institut de cancérologie de Strasbourg Europe

    Strasbourg, Bas-Rhin, 67200, France

  • Institut De Cancerologie Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes - Hôpital de jour

    Marseille, Bouches-du-Rhône, 13273, France

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

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Other studies related to the condition(s) this trial covers.