Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    fight-205
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003610
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Metastatic Urothelial Carcinoma Unresectable Urothelial Carcinoma Drug: Pemigatinib Drug: Pembrolizumab Drug: Gemcitabine Drug: Carboplatin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemigatinib + Pembrolizumab
Combination of pemigatinib plus pembrolizumab.
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®

Experimental: Pemigatinib
Pemigatinib alone.
Drug: Pemigatinib
Pemigatinib at the protocol-specified dose administered orally.
Other Name: INCB054828

Active Comparator: Standard of Care
Chemotherapy or pembrolizumab.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to approximately 18 months ]
    Defined the time from the date of randomization until death due to any cause.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003610


Contacts
Layout table for location contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
Show Show 64 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: Luis Feliz Vinas, MD Incyte Corporation
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04003610    
Other Study ID Numbers: INCB 54828-205
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
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
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Urothelial carcinoma
fibroblast growth factor receptor (FGFR) inhibitor
FGFR3 mutation
FGFR3 rearrangement
metastatic
unresectable
cisplatin-ineligible
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Carboplatin
Pembrolizumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological