Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Sponsor
Johannes Gutenberg University Mainz
Study ID
NCT04066595
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    60 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.

Study Details

In this Phase II study we investigate the benefit of cabozantinib treatment for patients with locally advanced or metastasized urothelial cell carcinoma who have been pre-treated with checkpoint inhibitors only (cohort 1) or who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (cohort 2). We are lacking adequate response and outcome data in patients after immunotherapy and consider that this study will improve future treatment modalities for this important patient cohort.

Key Dates

Start date
Feb 10, 2020
Status verified
Aug 2021
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental (cohorts 1 and 2)
    Cohort 1 will consist of patients who have been pre-treated with checkpoint inhibitors only (2nd line setting for cabozantinib). Cohort 2 will consist of patients who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (3rd line setting for cabozantinib). Both cohorts receive the same treatment.

Primary Outcome Measure

Objective response rate after 6 months of cabozantinib treatment [ Time Frame: 6 months ]

Related Studies