Study of CAbozantinib in Combination With AtezolizumaB for Muscle-Invasive BladdEr Cancer (ABATE) (ABATE)
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|ClinicalTrials.gov Identifier: NCT04289779|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : April 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Cabozantinib Drug: Atezolizumab Procedure: Cystectomy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of CAbozantinib in Combination With AtezolizumaB as NeoAdjuvant Treatment for Muscle-Invasive BladdEr Cancer (ABATE)|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Treatment Arm
Cabozantinib 40 mg orally daily x 9 weeks plus Atezolizumab 1200 mg every 3 weeks x 3 doses
Cabozantinib 40 mg orally daily for 3 cycles
Other Name: cabometyx
Atezolizumab 1200 mg IV every 3 weeks for 3 cycles
Other Name: Tecentriq
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.
- Pathologic Response Rate [ Time Frame: 12 months ]Estimate the pathologic response (PaR) rate to neoadjuvant cabozantinib and atezolizumab in subjects with muscle-invasive urothelial cancer of the bladder. Pathologic response rate (PaR) is defined as the absence of residual muscle-invasive cancer in the surgical specimen (pathologic downstaging to ≤ pT1pN0), which includes pT0, pT1, pTa, and pTis
- Frequency and Severity of Adverse Events [ Time Frame: 12 months ]Assess the frequency and severity of adverse events per CTCAE v5
- Pathologic complete response rate [ Time Frame: 12 months ]Estimate the pathologic complete response (pCR) rate to neoadjuvant cabozantinib and atezolizumab in subjects with muscle-invasive urothelial cancer of the bladder. pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per local institutional pathology review using specimens obtained via cystectomy following the neoadjuvant treatment.
- Event Free Survival [ Time Frame: 12 months ]EFS is defined as the time from registration to the first recurrence of disease after cystectomy, the time of first documented progression in patients who are precluded from cystectomy, or the time of death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289779
|Contact: Deepak Kilari, MD||(414) email@example.com|
|Contact: Julia Beck||317-634-5842 ext firstname.lastname@example.org|
|Principal Investigator:||Deepak Kilari, MD||Medical College of Wisconsin|