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Advanced and Metastatic Urothelial CancerPhase 2NCT04601857

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

A Phase 2 study testing Futibatinib and Pembrolizumab in people with Advanced and Metastatic Urothelial Cancer, run by Taiho Oncology, Inc. at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Futibatinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
18 sitesin 3 countries
Study dates
7 Jan 2021to 16 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent for the trial.
  • Age ≥ 18 years of age
  • Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.
  • Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.
  • 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)
  • Unfit for or intolerant to standard platinum-based chemotherapy.
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  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  • Adequate organ function.
  • Have a measurable disease per RECIST 1.1

Who cannot join

  • Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.
  • History and/or current evidence of any of the following disorders:
  • Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.
  • Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.
  • Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
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  • Have an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  • Have had an allogenic tissue/ organ transplant.
  • 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.
  • Have known active central nervous system metastases and/or carcinomatous meningitis.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Spain8 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 8035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario HMN Sanchinarro

    Madrid, 28050

  • ALTHAIA, Xarxa Assistencial Universitària de Manresa

    Manresa, Brcelona, 8243

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital la Fe

    Valencia, 46026

Other trials in Spain

France6 sites

  • Centre Georges-François Leclerc

    Dijon, Côte d'Or, 21079

  • Centre Leon Berard - departement d'oncologie medicale

    Lyon, Rhone, 69373

  • Institut Paoli Calmettes - Hôpital de jour

    Marseille, Bouches-du-Rhône, 13273

  • ICANS - Institut de cancérologie de Strasbourg Europe

    Strasbourg, Bas-Rhin, 67200

  • Centre Regional de Lutte Contre le Cancer de Lorraine

    Vandœuvre-lès-Nancy, 54500

  • Institut De Cancerologie Gustave Roussy

    Villejuif, 94805

Other trials in France

United States4 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Comprehensive Care Centers of Nevada

    Las Vegas, Nevada, 89148

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

Other trials in United States

About this study

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

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.

Being tested
Futibatinib, Pembrolizumab
Keywords
Futibatinib, Pembrolizumab, Urothelial cancer, FGFR, TAS120, MK3475 B04

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FutibatinibDrug

    Also called TAS120

    Oral

  • PembrolizumabDrug

    Also called KEYTRUDA, MK-3475-B04

    IV

Study groups in NCT04601857
Study groupRoleWhat they receive
Cohort AExperimentalParticipants 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.
Receives: Drug: Futibatinib; Drug: Pembrolizumab
Cohort BExperimentalParticipants 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.
Receives: Drug: Futibatinib; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1) criteria based on investigator assessment. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to less than (<)10 millimeters (mm).

    Measured: Up to 38 months

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    DCR was defined as the proportion of participants experiencing a best overall response of SD, PR, or CR. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis <10 mm.

    Measured: Up to 38 months

  2. Duration of Response (DOR)

    DOR was calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10 mm.

    Measured: Up to 38 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurred first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last tumor assessment. The 95% confidence interval (CI) for median PFS was provided using the Kaplan-Meier procedure.

    Measured: Up to 38 months

  4. Overall Survival (OS)

    OS was defined as the time from the date of the first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive.

    Measured: Up to 38 months

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. TEAEs are defined as AEs reported up to 30 days after the last dose of any study therapy (safety follow-up) or until the start of new antitumor therapy, whichever is earlier, unless otherwise specified.

    Measured: Up to 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start7 Jan 2021
  3. Primary completion8 Mar 2024
  4. Study completion16 Sep 2025

Why it stopped: Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601857
Sponsor's protocol ID
TAS-120-203
Other IDs
2020-000945-15
Status last verified
Dec 2025
First submitted
15 Oct 2020
Last updated
31 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Futibatinib and Pembrolizumab in people with Advanced and Metastatic Urothelial Cancer, run by Taiho Oncology, Inc. at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 38 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04601857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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