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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
Results First Posted : May 25, 2022
Last Update Posted : May 26, 2022
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 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 : May 14, 2020
Actual Primary Completion Date : April 18, 2021
Actual Study Completion Date : April 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemigatinib + Pembrolizumab
Combination of pemigatinib (13.5 milligrams [mg] once a day orally) plus pembrolizumab (200 mg every 3 weeks [Q3W] intravenously [IV])
Drug: Pemigatinib
13.5 mg once a day orally
Other Name: INCB054828

Drug: Pembrolizumab
200 mg Q3W intravenously
Other Name: Keytruda®

Experimental: Pemigatinib
Pemigatinib (13.5 mg once a day orally) alone
Drug: Pemigatinib
13.5 mg once a day orally
Other Name: INCB054828

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

Drug: Carboplatin
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 Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 130 days ]
    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 :
  1. Overall Survival (OS) [ Time Frame: up to 225 days ]
    OS was defined as the time from the date of randomization until death due to any cause.

  2. Objective Response Rate (ORR) [ Time Frame: up to 148 days ]
    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).

  3. Duration of Response (DOR) [ Time Frame: up to 148 days ]
    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).

  4. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: up to 178 days ]
    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.

  5. EORTC QLQ-C30 Score [ Time Frame: up to 160 days ]
    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.

  6. Change From Baseline in the EORTC QLQ-C30 Score [ Time Frame: Baseline; up to 160 days ]
    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.

  7. Number of Participants With the Indicated EQ-5D-5L Dimension Scores [ Time Frame: up to 160 days ]
    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.

  8. Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score [ Time Frame: Baseline; up to 160 days ]
    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.



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.


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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


Locations
Show Show 79 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Luis Feliz Vinas, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] April 17, 2020
Statistical Analysis Plan  [PDF] February 23, 2021

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04003610    
Other Study ID Numbers: INCB 54828-205
First Posted: July 1, 2019    Key Record Dates
Results First Posted: May 25, 2022
Last Update Posted: May 26, 2022
Last Verified: May 2022
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

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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:
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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