Clinical Trials /

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

NCT04003610

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-205
  • NCT ID: NCT04003610

Conditions

  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Interventions

DrugSynonymsArms
PemigatinibINCB054828Pemigatinib + Pembrolizumab
PembrolizumabKeytruda®Pemigatinib + Pembrolizumab
GemcitabineStandard of Care
CarboplatinStandard of Care

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pemigatinib + PembrolizumabExperimentalCombination of pemigatinib plus pembrolizumab.
  • Pemigatinib
  • Pembrolizumab
PemigatinibExperimentalPemigatinib alone.
  • Pemigatinib
Standard of CareActive ComparatorChemotherapy or pembrolizumab.
  • Pembrolizumab
  • Gemcitabine
  • Carboplatin

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 18 months
Safety Issue:
Description: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

Measure:Overall survival (OS)
Time Frame:Up to approximately 18 months
Safety Issue:
Description:Defined the time from the date of randomization until death due to any cause.
Measure:Objective response rate (ORR)
Time Frame:Up to approximately 18 months
Safety Issue:
Description:Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1.
Measure:Duration of response (DOR)
Time Frame:Up to approximately 18 months
Safety Issue:
Description: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.
Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximately 18 months
Safety Issue:
Description:Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Measure: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
Safety Issue:
Description:European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire.
Measure: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.
Safety Issue:
Description:European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire.
Measure: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.
Safety Issue:
Description:5-level version of the EuroQol-5D instrument.
Measure: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.
Safety Issue:
Description:5-level version of the EuroQol-5D instrument.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

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

Last Updated

December 4, 2019