Atezolizumab + Chemotherapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen bySamuel Funt, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to compare any good and bad effects the study drug atezolizumab has on the cancer when combined with the standard chemotherapy drugs gemcitabine and cisplatin (or GC) in two different dosing schedules: chemotherapy (GC) before atezolizumab vs. GC after atezolizumab.

Eligibility Criteria

Adults with advanced bladder cancer that can't be surgically removed or has spread, who haven't had chemotherapy or immunotherapy for metastatic disease. They must have a life expectancy of at least 12 weeks, measurable disease amenable to biopsy, and agree to use effective contraception post-treatment. Excluded are those with prior transplants, heart disease class III/IV, certain recent treatments including investigational drugs and systemic steroids, known liver diseases or bone marrow disorders, active infections like HIV/Hepatitis B/C/TB, severe allergies to specific antibodies or proteins.

Inclusion Criteria

I am fully active or can carry out light work.

Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73m^2

Life expectancy ≥ 12 weeks

+10 more

Exclusion Criteria

I haven't had cancer treatment in the last 3 weeks.

I have not had any other cancers in the last 5 years.

I have been treated with drugs targeting PD-1 or PD-L1.

+25 more

Participant Groups

The trial is testing the effectiveness of Atezolizumab (an immune therapy drug) combined with Gemcitabine and Cisplatin (chemotherapy drugs) in two different sequences: one where chemotherapy is given before Atezolizumab and another where it's given after. The goal is to see which sequence works better against metastatic bladder cancer.

3Treatment groups

Experimental Treatment

Group I: Atezolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions

Gemcitabine and Cisplatin for 2 cycles. One treatment cycle equals 21 days. After 2 cycles of Gemcitabine and Cisplatin patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 4 cycles. All 6 treatment cycles will take approximately 18 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator.

Group II: Atezolizumab alone with Gemcitabine and CisplatinExperimental Treatment3 Interventions

Atezolizumab alone for 2 cycles. One treatment cycle equals 21 days. Then patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 6 cycles. All 8 treatment cycles will take approximately 24 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator. This cohort is NO LONGER ACCRUING patients since 5/22/2018.

Group III: Atezolizumab alone for 1 cycle prior to gemcitabine, cisplatinExperimental Treatment3 Interventions

Atezolizumab alone for 1 cycle. One treatment cycle equals 21 days. After 1 cycle of atezolizumab the patients will receive combined atezolizumab and gemcitabine, cisplatin for 4 cycles. All 5 treatment cycles will take approximately 15 weeks. Cisplatin dose can be given on day 1 or split over days 1 and 8 at the investigator"s discretion. Once the split-dose cisplatin is used, it should be used for the remainder of the chemotherapy treatment course.

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

🇺🇸 Approved in United States as Tecentriq for: