Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Bladder cancer drug combo study halted early

NCT ID NCT04003610

Disease control Sponsor: Incyte Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether adding an immunotherapy drug (pembrolizumab) to a targeted therapy (pemigatinib) works better than the targeted therapy alone or standard care for people with advanced bladder cancer that has a specific gene change (FGFR3). The study was stopped early and only 7 people took part, so we cannot draw firm conclusions from it.

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

7 people

The number who actually took part.

Started

May 2020

Finished

Apr 2021

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: * Histologically documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%. * At least 1 measurable target lesion per RECIST v1.1. * Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed. * Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization. * Central laboratory test result of PD-L1 status is mandatory at screening. * Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence \> 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence \> 12 months since completion of therapy). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Prior receipt of a selective FGFR inhibitor for any indication or reason. * Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor. * Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease. * Concurrent anticancer therapy, except for treatment allowed per protocol. * Has disease that is suitable for local therapy administered with curative intent. * Has tumor with any neuroendocrine or small cell component. * Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. * Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment. * Has central nervous system metastases, unless the participant has completed local therapy (eg, whole brain radiation therapy, surgery, radiosurgery) and has discontinued use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. * Known additional malignancy that is progressing or required active treatment within the past 3 years * Laboratory values outside the protocol-defined range at screening. * Clinically significant or uncontrolled cardiac disease. * History of autoimmune disease that has required systemic treatment in past 2 years.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic urothelial carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Apert syndrome bladder transitional cell carcinoma Neoplasm Metastasis transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Metastatic urothelial carcinoma Unresectable urothelial carcinoma

Contacts and locations

Locations

  • Azosp S.Maria Sc Oncologia

    Terni, 05100, Italy

  • Barts Health Nhs Trust - St Bartholomews Hospital

    London, EC1A 7BE, United Kingdom

  • Centre Hospitalier Universitaire de Besancon

    Besançon, 25000, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)

    Lisbon, 1400-048, Portugal

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414, United States

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Christiana Care Helen F. Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Chu Nimes

    Nîmes, 30029, France

  • Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

    Strasbourg, 67091, France

  • Cotton-O'Neil Clinical Research Center, Hematology & Oncology

    Marietta, Georgia, 30067, United States

  • Fakultna Nemocnica S Poliklinikou Zilina

    Žilina, 01207, Slovakia

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Fonk Onkologian Klinikka

    Tampere, 33520, Finland

  • Grand Hopital de Charleroi

    Charleroi, 06000, Belgium

  • Groupe Hospitalier Pellegrin Tripode

    Bordeaux, 33075, France

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013, France

  • Hakodate Goryokaku Hospital

    Hokkaido, 040-8611, Japan

  • Helsinki University Meilahti Tower Hospital

    Helsinki, 00029, Finland

  • Hirosaki University Hospital

    Hirosaki-shi, 036-8563, Japan

  • Hopital Cochin Cancerologie

    Paris, 75014, France

  • Hopital Europeen Georges Pompidou (Hegp)

    Paris, 75015, France

  • Hospital Clinic I Provincial

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de La Paz

    Madrid, 28046, Spain

  • Ico Girona

    Girona, 17007, Spain

  • Ico Institut Catala D Oncologia

    Barcelona, 08908, Spain

  • Ieo Istituto Europeo Di Oncologia Irccs

    Milan, 20141, Italy

  • Institut Claudius Regaud Oncopole Toulouse

    Toulouse, 31100, France

  • Iov - Istituto Oncologico Veneto Irccs

    Bari, 70124, Italy

  • Irrcs Instituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Nazionale Tumori Fondazione Irccs G. Pascale

    Naples, 80131, Italy

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, 47014, Italy

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124, Italy

  • Jichi Medical University Hospital

    Shimotsuke-shi, 329-0498, Japan

  • Kagawa University Hospital

    Kita-gun, 761-0793, Japan

  • Keio University Hospital

    Shinjuku-ku, 160-8582, Japan

  • Kliniken Maria Hilf

    Mönchengladbach, 41063, Germany

  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

    Bologna, 40138, Italy

  • Marin Cancer Care

    Greenbrae, California, 94904, United States

  • Moncton Hospital - Horizon Health Network

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522, Japan

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • Nihon University Itabashi Hospital

    Itabashi-ku, 173-8610, Japan

  • Olsztynski Osrodek Onkologiczny Kopernik

    Olsztyn, 10-513, Poland

  • Onc Consultants Pharmacy 2

    Houston, Texas, 77030, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Osaka University Hospital

    Suita-shi, 565-0871, Japan

  • Polyclinique de Blois

    La Chaussée-Saint-Victor, 41260, France

  • Saitama Medical Center Jichi Medical University

    Saitama-shi, 330-8503, Japan

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298, Japan

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543, Japan

  • Simmons Cancer Institute At Siu

    Springfield, Illinois, 62702, United States

  • Smhc Cancer Blood Disorders

    Biddeford, Maine, 04005, United States

  • Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta

    Constanța, 900591, Romania

  • St. Marianna University School of Medicine Hospital

    Kawasaki-shi, 216-8511, Japan

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • The Center For Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • Tohoku University Hospital

    Sendai, 980-8574, Japan

  • Toranomon Hospital

    Minatoku, 105-8470, Japan

  • Toyama University Hospital

    Toyama, 930-0194, Japan

  • Turku University Hospital, Sct Unit

    Turku, 20521, Finland

  • UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA

    Roma, 00128, Italy

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • University Hospital Waterford

    Waterford, X91 ER8E, Ireland

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wilhelminenspital

    Vienna, 01160, Austria

More trials for these conditions

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