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

Phase 2

Terminated

• Conditions: Urothelial Carcinoma
• Interventions: Drug: Cabozantinib

• Registration Number: NCT04066595
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2020-02-10
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental (cohorts 1 and 2)	Cabozantinib	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 Measures

Name	Time	Method
Objective response rate after 6 months of cabozantinib treatment	6 months	The response rate is defined as the percentage of subjects with a confirmed reduction in tumor size compared to baseline as well as fulfilling the criteria for complete or partial response according to RECIST 1.1. The response to treatment is measured by computer tomography (CT) every 12 weeks starting from the first day of cabozantinib treatment.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Through study completion, up to approximately 2 years	PFS is defined as the time from first intake of trial medication to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
Response duration	Through study completion, up to approximately 2 years	Duration of response in months from the first response (CR or PR) to progress after first intake of treatment medication
Overall survival	Through study completion, up to approximately 2 years	The time between first application of trial medication to date of death due to any cause
1-year survival	1 year	Rate of subjects surviving for at least one year after first intake/dose of trial medication
Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)	Through study completion, up to approximately 2 years	The number of participants who discontinue study treatment due to an AE will be presented.
Clinical benefit rate	Through study completion, up to approximately 2 years	Complete or partial response or stable disease for ≥ 6 months according to RECIST 1.1
Number of Participants with Adverse Events (AEs)	Through study completion, up to approximately 2 years	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.

Trial Locations

Locations (1)

Department of Urology of the University Medical Center Mainz; 🇩🇪 Mainz, Germany