Atezolizumab + Cisplatin + Gemcitabine for Bladder Cancer

Palo Alto (17 mi)

Overseen bySamuel Funt, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety of the study drug, atezolizumab, when combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study will help researchers begin to understand whether combining GC with atezolizumab is better, the same, or worse than the usual approach of using GC alone.

Eligibility Criteria

Adults with bladder cancer that's invasive but hasn't been treated with chemotherapy or immunotherapy can join. They need to have a certain level of organ function, no severe allergies to the drug components, and agree to biopsies. Pregnant women and those with recent serious infections or heart issues cannot participate.

Treatment Details

The trial is testing if adding Atezolizumab (an immune system booster) to standard chemo drugs Gemcitabine and Cisplatin before surgery helps more than chemo alone. It's in phase II, so they're looking at how safe it is and how well it works.

1Treatment groups

Experimental Treatment

Group I: Atezolizumab, Gemcitabine, CisplatinExperimental Treatment3 Interventions

This is a two phase study with a single study arm for each phase. For Phase 1: Following enrollment participants will be treated with combination therapy on a 21 day cycle x 6 cycles. Gemcitabine (1000 mg/m2 on Day 1 and Day 8), cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously. Phase 2: Following enrollment participants will be treated with a single dose of atezolizumab alone followed by combination therapy on a 21-day cycle x 4 cycles, followed by a single dose of atezolizumab alone. Gemcitabine 1000mg/m2, cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.

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

🇺🇸 Approved in United States as Tecentriq for: