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Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer

NCT04289779 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-04

No results posted yet for this study

Summary

This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

Conditions

Interventions

DRUG

Cabozantinib

Cabozantinib 40 mg orally daily for 3 cycles

DRUG

Atezolizumab

Atezolizumab 1200 mg IV every 3 weeks for 3 cycles

PROCEDURE

Cystectomy

Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Medical College of Wisconsin

    collaborator OTHER

  • Deepak Kilari

    lead OTHER

Principal Investigators

  • Deepak Kilari, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-21
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289779 on ClinicalTrials.gov