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

Primary Purpose

Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Pembrolizumab
Gemcitabine
Carboplatin
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Urothelial Carcinoma focused on measuring Urothelial carcinoma, fibroblast growth factor receptor (FGFR) inhibitor, FGFR3 mutation, FGFR3 rearrangement, metastatic, unresectable, cisplatin-ineligible

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marin Cancer Care
  • Christiana Care Helen F. Graham Cancer Center
  • Cotton-O'Neil Clinical Research Center, Hematology & Oncology
  • Simmons Cancer Institute At Siu
  • The University of Kansas Cancer Center
  • Smhc Cancer Blood Disorders
  • Summit Medical Group
  • Mount Sinai School of Medicine
  • Oregon Health & Science University
  • Charleston Hematology Oncology Associates
  • Vanderbilt-Ingram Cancer Center
  • The Center For Cancer and Blood Disorders
  • Onc Consultants Pharmacy 2
  • Wilhelminenspital
  • Grand Hopital de Charleroi
  • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Moncton Hospital - Horizon Health Network
  • Helsinki University Meilahti Tower Hospital
  • Fonk Onkologian Klinikka
  • Turku University Hospital, Sct Unit
  • Centre Hospitalier Universitaire de Besancon
  • Groupe Hospitalier Pellegrin Tripode
  • Polyclinique de Blois
  • Chu Nimes
  • Groupe Hospitalier Pitie-Salpetriere
  • Hopital Cochin Cancerologie
  • Hopital Europeen Georges Pompidou (Hegp)
  • Centre Hospitalier Universitaire de Poitiers
  • Chu de Strasbourg Hopitaux Universitaires Service D Hematologie
  • Institut Claudius Regaud Oncopole Toulouse
  • Kliniken Maria Hilf
  • University Hospital Waterford
  • Iov - Istituto Oncologico Veneto Irccs
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
  • Fondazione Irccs Istituto Nazionale Dei Tumori
  • Ieo Istituto Europeo Di Oncologia Irccs
  • Fondazione Irccs Ca Granda Ospedale Maggiore
  • Istituto Nazionale Tumori Fondazione Irccs G. Pascale
  • UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA
  • Irrcs Instituto Clinico Humanitas
  • Azosp S.Maria Sc Oncologia
  • Chiba University Hospital
  • Chiba Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • Saitama Medical University International Medical Center
  • Hirosaki University Hospital
  • Hakodate Goryokaku Hospital
  • Sapporo Medical University Hospital
  • Nihon University Itabashi Hospital
  • Nara Medical University Hospital
  • St. Marianna University School of Medicine Hospital
  • Kagawa University Hospital
  • Nho Shikoku Cancer Center
  • Toranomon Hospital
  • Osaka International Cancer Institute
  • Saitama Medical Center Jichi Medical University
  • Tohoku University Hospital
  • Jichi Medical University Hospital
  • Keio University Hospital
  • Osaka University Hospital
  • National Cancer Center Hospital
  • Toyama University Hospital
  • Olsztynski Osrodek Onkologiczny Kopernik
  • Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)
  • Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta
  • Fakultna Nemocnica S Poliklinikou Zilina
  • Hospital Clinic I Provincial
  • Ico Institut Catala D Oncologia
  • Ico Girona
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario de La Paz
  • Hospital Universitario Hm Sanchinarro
  • Hospital Puerta de Hierro
  • Hospital Universitario Virgen Del Rocio
  • Hospital Clinico Universitario de Valencia
  • Barts Health Nhs Trust - St Bartholomews Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pemigatinib + Pembrolizumab

Pemigatinib

Standard of Care

Arm Description

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

Pemigatinib (13.5 mg once a day orally) alone

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2019
Last Updated
May 24, 2022
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04003610
Brief Title
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
April 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
Keywords
Urothelial carcinoma, fibroblast growth factor receptor (FGFR) inhibitor, FGFR3 mutation, FGFR3 rearrangement, metastatic, unresectable, cisplatin-ineligible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemigatinib + Pembrolizumab
Arm Type
Experimental
Arm Description
Combination of pemigatinib (13.5 milligrams [mg] once a day orally) plus pembrolizumab (200 mg every 3 weeks [Q3W] intravenously [IV])
Arm Title
Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib (13.5 mg once a day orally) alone
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
13.5 mg once a day orally
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®
Intervention Description
200 mg Q3W intravenously
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
up to 130 days
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization until death due to any cause.
Time Frame
up to 225 days
Title
Objective Response Rate (ORR)
Description
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).
Time Frame
up to 148 days
Title
Duration of Response (DOR)
Description
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).
Time Frame
up to 148 days
Title
Number of Participants With Treatment-emergent Adverse Events
Description
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.
Time Frame
up to 178 days
Title
EORTC QLQ-C30 Score
Description
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.
Time Frame
up to 160 days
Title
Change From Baseline in the EORTC QLQ-C30 Score
Description
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.
Time Frame
Baseline; up to 160 days
Title
Number of Participants With the Indicated EQ-5D-5L Dimension Scores
Description
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.
Time Frame
up to 160 days
Title
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score
Description
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.
Time Frame
Baseline; up to 160 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Feliz Vinas, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Christiana Care Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Hematology & Oncology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Simmons Cancer Institute At Siu
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Smhc Cancer Blood Disorders
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Center For Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Onc Consultants Pharmacy 2
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
01160
Country
Austria
Facility Name
Grand Hopital de Charleroi
City
Charleroi
ZIP/Postal Code
06000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
Moncton Hospital - Horizon Health Network
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Helsinki University Meilahti Tower Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Fonk Onkologian Klinikka
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Hospital, Sct Unit
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Groupe Hospitalier Pellegrin Tripode
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Polyclinique de Blois
City
La Chaussee-saint-victor
ZIP/Postal Code
41260
Country
France
Facility Name
Chu Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Cochin Cancerologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Europeen Georges Pompidou (Hegp)
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Chu de Strasbourg Hopitaux Universitaires Service D Hematologie
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Claudius Regaud Oncopole Toulouse
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Kliniken Maria Hilf
City
Moenchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
University Hospital Waterford
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione Irccs Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ieo Istituto Europeo Di Oncologia Irccs
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione Irccs Ca Granda Ospedale Maggiore
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Irccs G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Irrcs Instituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azosp S.Maria Sc Oncologia
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Hakodate Goryokaku Hospital
City
Hokkaido
ZIP/Postal Code
040-8611
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara-shi
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Nho Shikoku Cancer Center
City
Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama-shi
ZIP/Postal Code
330-8503
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Olsztynski Osrodek Onkologiczny Kopernik
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)
City
Lisboa
ZIP/Postal Code
1400-048
Country
Portugal
Facility Name
Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Fakultna Nemocnica S Poliklinikou Zilina
City
Zilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Ico Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Barts Health Nhs Trust - St Bartholomews Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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