Atezolizumab for Bladder Cancer

Recruiting at 302 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, RANKL inhibitors

Disqualifiers: Systemic chemotherapy, Radiation, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 29

Duration: 51 weeks

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who Is on the Research Team?

Peter C Black

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with recurrent, non-muscle invasive bladder cancer that hasn't responded to BCG therapy. Eligible participants must have had all visible tumors removed recently and can't have muscle invasive bladder cancer or certain other cancers. They need normal blood counts, liver and kidney function, no severe allergies to Chinese hamster products, no recent immunosuppressive treatments or live vaccines, and cannot be pregnant.

Inclusion Criteria

Any side effects from my past surgery or bladder treatments have mostly gone away.

I have not had any other cancer types, except for certain allowed cases.

Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies

Exclusion Criteria

I am not pregnant or nursing and will use birth control during and after the study.

I haven't had chemotherapy or immunotherapy for bladder cancer, nor vaccines in the last 6 weeks.

I am not planning to undergo any other cancer treatments while on this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab intravenously over 60 minutes on day 1, with treatment repeating every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity

51 weeks

17 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 12 weeks for 2 years and then every 24 weeks for 3 years

5 years

Every 12 weeks for 2 years, then every 24 weeks for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab

Trial Overview The trial is testing the effectiveness of Atezolizumab, a monoclonal antibody immunotherapy drug. It aims to see if this treatment can help the immune system fight off bladder cancer cells that have returned after failing to respond to previous BCG therapy.

How Is the Trial Designed?

Group I: Treatment (atezolizumab) Experimental Treatment 1 Intervention

Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+