Atezolizumab for Bladder Cancer

No longer recruiting at 307 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively atezolizumab, an immunotherapy, treats bladder cancer that has not responded to previous treatments and has recurred. Atezolizumab helps the immune system attack cancer cells, potentially stopping their growth and spread. It targets individuals with bladder cancer that has returned despite BCG treatment (a type of immunotherapy) and who cannot or do not wish to undergo surgery. Participants should have recently had their cancer completely removed and be BCG-unresponsive, meaning their cancer did not respond to past BCG treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot take certain medications like systemic immunosuppressive drugs or receive live vaccines shortly before or during the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that atezolizumab is likely to be safe for humans?

Research has shown that atezolizumab, a type of immunotherapy, offers promising safety results. Studies have found that it can extend the lives of patients with certain cancers, with side effects that are usually manageable.

In one study involving patients with bladder cancer, atezolizumab helped them live longer without their cancer worsening. This indicates that atezolizumab is generally well-tolerated, with most side effects being mild to moderate.

Serious side effects can occur, but they are less common. Discussing expectations and side effect management with a doctor is important for making an informed decision about joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bladder cancer, which often involve chemotherapy or surgery, atezolizumab works differently by harnessing the body’s immune system to fight cancer. Atezolizumab is a type of immunotherapy known as a PD-L1 inhibitor, which blocks the protein PD-L1 on cancer cells, allowing the immune system to better recognize and attack these cells. This mechanism offers a more targeted approach, potentially leading to fewer side effects and improved outcomes for patients. Researchers are excited about its potential to provide a new option for those who may not respond well to conventional treatments.

What evidence suggests that atezolizumab might be an effective treatment for bladder cancer?

Research shows that atezolizumab, which participants in this trial will receive, can effectively treat bladder cancer. Studies have found that it helps patients with urothelial cancer, a type of bladder cancer, live longer and delay disease progression. Atezolizumab boosts the immune system to attack cancer cells, potentially slowing their growth and spread. Patients with advanced urothelial cancer who did not respond to other treatments found atezolizumab both effective and manageable. Long-term evidence indicates that some patients experience lasting benefits from this treatment. ^{3 4 5 6 7}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37537512/

Outcomes with atezolizumab in metastatic urothelial cancer In this retrospective study, atezolizumab was an effective and tolerable treatment option for patients with mUC after progression to platinum-based ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983893/

Efficacy and safety of atezolizumab in the treatment ... Atezolizumab has demonstrated significant improvements in OS and PFS among patients with UC, offering crucial insights for decision-making in UC immunotherapy.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456920302698

Atezolizumab in Patients with Metastatic Urothelial ... Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy.

4. esmoopen.com esmoopen.com/article/S2059-7029(24)01742-3/fulltext

final analysis from the phase II IMvigor210 trial These final long-term data show that atezolizumab provides durable clinical benefit to a subset of patients with mUC. Abstract. Background. The ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511885?query=featured_home

ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive ... Among 357 patients with persistent ctDNA-negative status, disease-free survival was 95% at the end of the 1-year monitoring period and 88% at 2 ...

6. roche.com roche.com/media/releases/med-cor-2025-10-20b

Roche's Tecentriq showed significant overall and disease- ... Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo1; IMvigor011 is the ...

7. gene.com gene.com/media/press-releases/15084/2025-10-19/genentechs-tecentriq-showed-significant-

Genentech: Press Releases | Sunday, Oct 19, 2025 Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo.