Cabozantinib + Atezolizumab for Bladder Cancer
(ABATE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byDeepak Kilari

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Deepak Kilari

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with muscle-invasive bladder cancer who can't have or don't want cisplatin-based therapy. They should be fit for surgery, not pregnant, willing to use contraception, and free from HIV/AIDS, severe infections, other active cancers (except certain cases), significant heart disease, and uncontrolled illnesses. Prior treatments and allergies to study drugs are also considered.

Inclusion Criteria

I haven't had radiation therapy in the last 4 weeks, especially not to the bladder.

Must have a life expectancy of at least 12 weeks at registration.

My surgeon agrees I can undergo major bladder surgery.

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Exclusion Criteria

I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after the study.

You have a history of severe allergic reactions to certain types of medications, or rare hereditary problems with digesting certain sugars.

Treatment with any investigational drug within 30 days prior to registration.

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Treatment Details

Interventions

Atezolizumab (PD-L1 Inhibitor)
Cabozantinib (Tyrosine Kinase Inhibitor)
Cystectomy (Surgery)

Trial OverviewThe trial tests cabozantinib taken orally daily combined with atezolizumab given intravenously every three weeks in patients before they undergo cystectomy. The goal is to see how well these drugs work together against bladder cancer when cisplatin isn't an option.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment3 Interventions

Cabozantinib 40 mg orally daily x 9 weeks plus Atezolizumab 1200 mg every 3 weeks x 3 doses

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: