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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003610
Recruitment Status : Terminated (The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.)
First Posted : July 1, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date October 6, 2021
Actual Study Start Date  ICMJE November 12, 2019
Actual Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
Progression-free survival (PFS) [ Time Frame: Up to approximately 18 months ]
Defined as the time from randomization date until the date of disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurs first.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Overall survival (OS) [ Time Frame: Up to approximately 18 months ]
    Defined the time from the date of randomization until death due to any cause.
  • Objective response rate (ORR) [ Time Frame: Up to approximately 18 months ]
    Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1.
  • Duration of response (DOR) [ Time Frame: Up to approximately 18 months ]
    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 occurs first.
  • Number of treatment-emergent adverse events [ Time Frame: Up to approximately 18 months ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
  • EORTC QLQ-C30 score [ Time Frame: Starting at Cycle 4, every 9 weeks for 1 year then every 12 weeks thereafter, up to approximately 18 months ]
    European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire.
  • Change from baseline in EORTC QLQ C30 score [ Time Frame: From Baseline to starting at Cycle 4, every 9 weeks for 1 year then every 12 weeks thereafter, up to approximately 18 months. ]
    European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire.
  • EQ-5D-5L score [ Time Frame: Starting at Cycle 4, every 9 weeks for 1 year then every 12 weeks thereafter, up to approximately 18 months. ]
    5-level version of the EuroQol-5D instrument.
  • Change from baseline in EQ-5D-5L score [ Time Frame: From Baseline to starting at Cycle 4, every 9 weeks for 1 year then every 12 weeks thereafter, up to approximately 18 months. ]
    5-level version of the EuroQol-5D instrument.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma
Intervention  ICMJE
  • Drug: Pemigatinib
    Pemigatinib at the protocol-specified dose administered orally.
    Other Name: INCB054828
  • Drug: Pembrolizumab
    Pembrolizumab at the protocol-specified dose administered intravenously.
    Other Name: Keytruda®
  • Drug: Gemcitabine
    Gemcitabine at the protocol-specified dose administered intravenously with carboplatin.
  • Drug: Carboplatin
    Carboplatin at the protocol-specified dose administered intravenously with gemcitabine.
Study Arms  ICMJE
  • Experimental: Pemigatinib + Pembrolizumab
    Combination of pemigatinib plus pembrolizumab.
    Interventions:
    • Drug: Pemigatinib
    • Drug: Pembrolizumab
  • Experimental: Pemigatinib
    Pemigatinib alone.
    Intervention: Drug: Pemigatinib
  • Active Comparator: Standard of Care
    Chemotherapy or pembrolizumab.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Gemcitabine
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 7, 2021)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2019)
372
Actual Study Completion Date  ICMJE April 18, 2021
Actual Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Finland,   France,   Germany,   Ireland,   Italy,   Japan,   Poland,   Portugal,   Romania,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003610
Other Study ID Numbers  ICMJE INCB 54828-205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
URL: https://www.incyte.com/our-company/compliance-and-transparency
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luis Feliz Vinas, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP