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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Deepak Kilari
Study ID
NCT04289779
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib 40 mg orally daily for 3 cycles
  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV every 3 weeks for 3 cycles
  • Cystectomy — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
May 21, 2020
Status verified
Dec 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Treatment Arm
    Cabozantinib 40 mg orally daily x 9 weeks plus Atezolizumab 1200 mg every 3 weeks x 3 doses

Primary Outcome Measure

Pathologic Response Rate [ Time Frame: 12 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-
John Theurer Cancer CenterHackensackNew Jersey07601-
University of Rochester Medical CenterRochesterNew York14642-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Virginia Commonwealth UniversityRichmondVirginia23298-
Froedtert and The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in St Louis, MO

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Washington University School of Medicine· St Louis, MOJohn Theurer Cancer Center· Hackensack, NJUniversity of Rochester Medical Center· Rochester, NYVanderbilt-Ingram Cancer Center· Nashville, TNVirginia Commonwealth University· Richmond, VAFroedtert and The Medical College of Wisconsin· Milwaukee, WI

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