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

NCT04003610 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: INCB 54828-2052019-000721-50
• Study Type: interventional
• Target: 7
• Locations: 16 countries
• Sites: 79

Brief 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 have not received prior treatment.

Conditions

Metastatic Urothelial Carcinoma; Unresectable Urothelial Carcinoma

Keywords

Urothelial carcinoma; fibroblast growth factor receptor (FGFR) inhibitor; FGFR3 mutation; FGFR3 rearrangement; metastatic; unresectable; cisplatin-ineligible

Outcome Measures

Primary Outcomes (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.

  up to 130 days

Secondary Outcomes (8)

• Overall Survival (OS)

  up to 225 days

• Objective Response Rate (ORR)

  up to 148 days

• Duration of Response (DOR)

  up to 148 days

• Number of Participants With Treatment-emergent Adverse Events

  up to 178 days

• EORTC QLQ-C30 Score

  up to 160 days

Study Arms (3)

Pemigatinib + Pembrolizumab

EXPERIMENTAL

Combination of pemigatinib (13.5 milligrams \[mg\] once a day orally) plus pembrolizumab (200 mg every 3 weeks \[Q3W\] intravenously \[IV\])

Drug: Pemigatinib; Drug: Pembrolizumab

Pemigatinib

EXPERIMENTAL

Pemigatinib (13.5 mg once a day orally) alone

Drug: Pemigatinib

Standard of Care

ACTIVE COMPARATOR

Either 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.

Drug: Gemcitabine; Drug: Carboplatin

Interventions

Pemigatinib DRUG

13.5 mg once a day orally

Also known as: INCB054828

Pemigatinib; Pemigatinib + Pembrolizumab

Pembrolizumab DRUG

200 mg Q3W intravenously

Also known as: Keytruda®

Pemigatinib + Pembrolizumab

Gemcitabine DRUG

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

Standard of Care

Carboplatin DRUG

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (79)

Marin Cancer Care

Greenbrae, California, 94904, United States

Location

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

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

Marietta, Georgia, 30067, United States

Location

Simmons Cancer Institute At Siu

Springfield, Illinois, 62702, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Smhc Cancer Blood Disorders

Biddeford, Maine, 04005, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

The Center For Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Onc Consultants Pharmacy 2

Houston, Texas, 77030, United States

Location

Wilhelminenspital

Vienna, 01160, Austria

Location

Grand Hopital de Charleroi

Charleroi, 06000, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Moncton Hospital - Horizon Health Network

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Helsinki University Meilahti Tower Hospital

Helsinki, 00029, Finland

Location

Fonk Onkologian Klinikka

Tampere, 33520, Finland

Location

Turku University Hospital, Sct Unit

Turku, 20521, Finland

Location

Centre Hospitalier Universitaire de Besancon

Besançon, 25000, France

Location

Groupe Hospitalier Pellegrin Tripode

Bordeaux, 33075, France

Location

Polyclinique de Blois

La Chaussée-Saint-Victor, 41260, France

Location

Chu Nimes

Nîmes, 30029, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Hopital Cochin Cancerologie

Paris, 75014, France

Location

Hopital Europeen Georges Pompidou (Hegp)

Paris, 75015, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

Strasbourg, 67091, France

Location

Institut Claudius Regaud Oncopole Toulouse

Toulouse, 31100, France

Location

Kliniken Maria Hilf

Mönchengladbach, 41063, Germany

Location

University Hospital Waterford

Waterford, X91 ER8E, Ireland

Location

Iov - Istituto Oncologico Veneto Irccs

Bari, 70124, Italy

Location

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, 70124, Italy

Location

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

Bologna, 40138, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, 47014, Italy

Location

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Ieo Istituto Europeo Di Oncologia Irccs

Milan, 20141, Italy

Location

Istituto Nazionale Tumori Fondazione Irccs G. Pascale

Napoli, 80131, Italy

Location

UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA

Roma, 00128, Italy

Location

Irrcs Instituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Azosp S.Maria Sc Oncologia

Terni, 05100, Italy

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, 350-1298, Japan

Location

Hirosaki University Hospital

Hirosaki-shi, 036-8563, Japan

Location

Hakodate Goryokaku Hospital

Hokkaido, 040-8611, Japan

Location

Sapporo Medical University Hospital

Hokkaido, 060-8543, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, 173-8610, Japan

Location

Nara Medical University Hospital

Kashihara-shi, 634-8522, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki-shi, 216-8511, Japan

Location

Kagawa University Hospital

Kita-gun, 761-0793, Japan

Location

Nho Shikoku Cancer Center

Matsuyama, 791-0280, Japan

Location

Toranomon Hospital

Minatoku, 105-8470, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Saitama Medical Center Jichi Medical University

Saitama-shi, 330-8503, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, 329-0498, Japan

Location

Keio University Hospital

Shinjuku-ku, 160-8582, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Olsztynski Osrodek Onkologiczny Kopernik

Olsztyn, 10-513, Poland

Location

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

Lisbon, 1400-048, Portugal

Location

Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta

Constanța, 900591, Romania

Location

Fakultna Nemocnica S Poliklinikou Zilina

Žilina, 01207, Slovakia

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Ico Institut Catala D Oncologia

Barcelona, 08908, Spain

Location

Ico Girona

Girona, 17007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Barts Health Nhs Trust - St Bartholomews Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Acrocephalosyndactylia; Neoplasm Metastasis

Interventions

pemigatinib; pembrolizumab; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Limitations and Caveats

The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only 7 participants, no analysis of efficacy endpoints was done.

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Luis Feliz Vinas, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 1, 2019
• Study Start: May 14, 2020
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: November 4, 2025
• Results First Posted: May 25, 2022

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

IT (11); FI (3); PL (1); JP (21); GB (1); CA (1); SL (1); RO (1); US (13); PT (1); BE (2); IE (1); FR (10); AU (1); ES (10); DE (1)