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Metastatic Urothelial CarcinomaPhase 2NCT04003610

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

A Phase 2 study testing Pemigatinib, Pembrolizumab and Gemcitabine in people with Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, run by Incyte Corporation at 79 sites in 16 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 this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pemigatinib, Pembrolizumab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
79 sitesin 16 countries
Study dates
14 May 2020to 18 Apr 2021
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

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

79 sites in 16 countries.

79 sites in 16 countries

Japan21 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298

  • Hirosaki University Hospital

    Hirosaki-shi, 036-8563

  • Hakodate Goryokaku Hospital

    Hokkaido, 040-8611

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522

  • St. Marianna University School of Medicine Hospital

    Kawasaki-shi, 216-8511

  • Kagawa University Hospital

    Kita-gun, 761-0793

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280

  • Toranomon Hospital

    Minatoku, 105-8470

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Medical Center Jichi Medical University

    Saitama-shi, 330-8503

  • Tohoku University Hospital

    Sendai, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke-shi, 329-0498

  • Keio University Hospital

    Shinjuku-ku, 160-8582

  • Osaka University Hospital

    Suita-shi, 565-0871

  • Nihon University Itabashi Hospital

    tabashi City, 173-8610

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Toyama University Hospital

    Toyama, 930-0194

Other trials in Japan

United States13 sites

  • Smhc Cancer Blood Disorders

    Biddeford, Maine, 04005

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • The Center For Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Onc Consultants Pharmacy 2

    Houston, Texas, 77030

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

    Marietta, Georgia, 30067

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Christiana Care Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Simmons Cancer Institute At Siu

    Springfield, Illinois, 62702

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Italy11 sites

  • Iov - Istituto Oncologico Veneto Irccs

    Bari, 70124

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124

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

    Bologna, 40138

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

    Meldola, 47014

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • Ieo Istituto Europeo Di Oncologia Irccs

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione Irccs G. Pascale

    Naples, 80131

  • UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA

    Roma, 00128

  • Irrcs Instituto Clinico Humanitas

    Rozzano, 20089

  • Azosp S.Maria Sc Oncologia

    Terni, 05100

Other trials in Italy

France10 sites

  • Centre Hospitalier Universitaire de Besancon

    Besançon, 25000

  • Groupe Hospitalier Pellegrin Tripode

    Bordeaux, 33075

  • Polyclinique de Blois

    La Chaussée-Saint-Victor, 41260

  • Chu Nimes

    Nîmes, 30029

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hopital Cochin Cancerologie

    Paris, 75014

  • Hopital Europeen Georges Pompidou (Hegp)

    Paris, 75015

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

    Strasbourg, 67091

  • Institut Claudius Regaud Oncopole Toulouse

    Toulouse, 31100

Other trials in France

Spain10 sites

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Ico Institut Catala D Oncologia

    Barcelona, 08908

  • Ico Girona

    Girona, 17007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Finland3 sites

  • Helsinki University Meilahti Tower Hospital

    Helsinki, 00029

  • Fonk Onkologian Klinikka

    Tampere, 33520

  • Turku University Hospital, Sct Unit

    Turku, 20521

Other trials in Finland

Belgium2 sites

  • Grand Hopital de Charleroi

    Charleroi, 06000

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

Other trials in Belgium

Austria1 site

  • Wilhelminenspital

    Vienna, 01160

Other trials in Austria

Canada1 site

  • Moncton Hospital - Horizon Health Network

    Moncton, New Brunswick, E1C 6Z8

Other trials in Canada

Germany1 site

  • Kliniken Maria Hilf

    Mönchengladbach, 41063

Other trials in Germany

Ireland1 site

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Poland1 site

  • Olsztynski Osrodek Onkologiczny Kopernik

    Olsztyn, 10-513

Other trials in Poland

Portugal1 site

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

    Lisbon, 1400-048

Other trials in Portugal

Romania1 site

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

    Constanța, 900591

Other trials in Romania

Slovakia1 site

  • Fakultna Nemocnica S Poliklinikou Zilina

    Žilina, 01207

Other trials in Slovakia

United Kingdom1 site

  • Barts Health Nhs Trust - St Bartholomews Hospital

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)

The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

Being tested
Pemigatinib, Pembrolizumab, Gemcitabine, Carboplatin
Keywords
Urothelial carcinoma, fibroblast growth factor receptor (FGFR) inhibitor, FGFR3 mutation, FGFR3 rearrangement, metastatic, unresectable, cisplatin-ineligible
Medical subject headings
Carcinoma, Transitional Cell, Acrocephalosyndactylia, Neoplasm Metastasis

What participants receive

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

  • PemigatinibDrug

    Also called INCB054828

    13.5 mg once a day orally

  • PembrolizumabDrug

    Also called Keytruda®

    200 mg Q3W intravenously

  • GemcitabineDrug

    1000 mg/m^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle

  • CarboplatinDrug

    Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle

Study groups in NCT04003610
Study groupRoleWhat they receive
Pemigatinib + PembrolizumabExperimentalCombination of pemigatinib (13.5 milligrams [mg] once a day orally) plus pembrolizumab (200 mg every 3 weeks [Q3W] intravenously [IV])
Receives: Drug: Pemigatinib; Drug: Pembrolizumab
PemigatinibExperimentalPemigatinib (13.5 mg once a day orally) alone
Receives: Drug: Pemigatinib
Standard of CareActive comparatorEither gemcitabine plus carboplatin or pembrolizumab as standard of care. Gemcitabine 1000 mg/meters squared (m^2) IV over 30 minutes on Days 1 and 8, followed by carboplatin (dosed to target area under the concentration-time curve [AUC] of 5 mg/milliliters [mL]/minute [min] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or 2 of each 3-week cycle. Pembrolizumab 200 mg IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.
Receives: Drug: Gemcitabine; Drug: Carboplatin

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS was defined as the time from the randomization date until the date of disease progression (as measured by a blinded independent central review [BICR] per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurred first.

    Measured: up to 130 days

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS was defined as the time from the date of randomization until death due to any cause.

    Measured: up to 225 days

  2. Objective Response Rate (ORR)

    ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 (as measured by BICR).

    Measured: up to 148 days

  3. Duration of Response (DOR)

    DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression (per RECIST v1.1) or death, whichever occurred first (as measured by BICR).

    Measured: up to 148 days

  4. Number of Participants With Treatment-emergent Adverse Events

    A treatment-emergent adverse event was defined as an adverse event that was either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug.

    Measured: up to 178 days

  5. EORTC QLQ-C30 Score

    The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual.

    Measured: up to 160 days

  6. Change From Baseline in the EORTC QLQ-C30 Score

    The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline; up to 160 days

  7. Number of Participants With the Indicated EQ-5D-5L Dimension Scores

    The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

    Measured: up to 160 days

  8. Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score

    The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 [worst overall health] to 100 [best overall health]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.

    Measured: Baseline; up to 160 days

Timeline

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

  1. First posted1 Jul 2019
  2. Study start14 May 2020
  3. Primary completion18 Apr 2021
  4. Study completion18 Apr 2021

Why it stopped: The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003610
Sponsor's protocol ID
INCB 54828-205
Other IDs
2019-000721-50, 2019
Status last verified
Oct 2025
First submitted
28 Jun 2019
Last updated
4 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemigatinib, Pembrolizumab and Gemcitabine in people with Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, run by Incyte Corporation at 79 sites in 16 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 8 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Japan, United States, Italy, France, Spain and 11 more countries. 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 25 May 2022). 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?

Progression-free Survival (PFS) (time frame: up to 130 days). 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 NCT04003610.

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 4 Nov 2025.

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