Clinical Trials /

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

NCT04045613

Description:

The purpose of this study is to evaluate efficacy of derazantinib single-agent or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer
  • Official Title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Clinical Trial IDs

  • ORG STUDY ID: DZB-CS-201
  • SECONDARY ID: 2019-000359-15
  • NCT ID: NCT04045613

Conditions

  • Urothelial Carcinoma

Interventions

DrugSynonymsArms
DerazantinibDerazantinib [Substudy 1]
Atezolizumab (drug supplied by Hoffmann-La Roche)Derazantinib + Atezolizumab: Dose finding [Substudy 2]

Purpose

The purpose of this study is to evaluate efficacy of derazantinib single-agent or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

Detailed Description

      The study comprises four open-label substudies in patients with advanced urothelial cancer
      harboring FGFR GA who will be treated by single-agent derazantinib or derazantinib in
      combination with atezolizumab. The study enrolls patients with cisplatin-ineligible status,
      or patients whose disease progressed after either first-line treatment or prior treatment
      with FGFR inhibitors.
    

Trial Arms

NameTypeDescriptionInterventions
Derazantinib [Substudy 1]ExperimentalPatients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib.
  • Derazantinib
Derazantinib + Atezolizumab: Dose finding [Substudy 2]ExperimentalDose finding and dose expansion in patients with solid tumor.
  • Derazantinib
  • Atezolizumab (drug supplied by Hoffmann-La Roche)
Derazantinib +/- Atezolizumab: First line [Substudy 3]ExperimentalPatients with urothelial cancer will be randomized for first-line treatment with either derazantinib alone or the recommended phase 2 dose (RP2D) for derazantinib-atezolizumab.
  • Derazantinib
  • Atezolizumab (drug supplied by Hoffmann-La Roche)
Derazantinib +/- Atezolizumab: Second line [Substudy 4]ExperimentalPatients with urothelial cancer progressing after prior FGFR inhibitor treatment will be randomized to receive either derazantinib alone or the RP2D for derazantinib-atezolizumab.
  • Derazantinib
  • Atezolizumab (drug supplied by Hoffmann-La Roche)

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or
             lower urinary tract

          -  Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or
             progressing disease

          -  Documented FGFR genetic alteration

          -  Measurable disease per RECIST 1.1

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

          -  Adequate bone marrow, liver and renal function

        Exclusion Criteria:

          -  Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an
             investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug
             whichever is longer before the first dose of study drug.

          -  Concurrent evidence of any corneal or retinal disorder

          -  Phosphatemia greater than institutional upper limit of normal (ULN) at screening

          -  Uncontrolled tumor-related hypercalcemia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR) based on RECIST 1.1
Time Frame:Approximately up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Disease control rate per RECIST 1.1
Time Frame:Approximately up to 2 years
Safety Issue:
Description:
Measure:Duration of Response per RECIST 1.1
Time Frame:Approximately up to 2 years
Safety Issue:
Description:
Measure:Median progression-free survival (PFS) and PFS at 6 months
Time Frame:Approximately up to 2 years
Safety Issue:
Description:
Measure:Median overall survival (OS) and OS at 6 months
Time Frame:Approximately up to 2 years
Safety Issue:
Description:
Measure:Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events
Time Frame:Approximately up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Basilea Pharmaceutica

Trial Keywords

  • metastatic urothelial cancer
  • bladder cancer
  • Fibroblast Growth Factor Receptor
  • FGFR genetic aberration
  • targeted therapy
  • derazantinib
  • checkpoint inhibitor
  • immune checkpoint blockade
  • atezolizumab
  • Tecentriq
  • solid tumor

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