Atezolizumab for High-Risk Bladder Cancer

(IMvigor011 Trial)

Not currently recruiting at 307 trial locations

Overseen By Reference Study ID Number: BO42843 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Pregnancy, HIV, Hepatitis, Tuberculosis, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 12

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether atezolizumab, a type of immunotherapy, can reduce the risk of bladder cancer returning after surgery. Participants include individuals who have undergone bladder cancer surgery and are at high risk for recurrence, particularly if certain cancer markers appear in their blood. The study compares atezolizumab with a placebo (a treatment with no active drug) to determine which is more effective at preventing cancer recurrence. Individuals who have recovered from bladder cancer surgery and have specific blood markers might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had any anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks before joining the study. Hormone-replacement therapy or oral contraceptives are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that atezolizumab, also known as Tecentriq, has promising results for extending patient survival. In past studies, patients receiving atezolizumab lived longer on average than those given a placebo. Specifically, the average survival time was 32.8 months with atezolizumab, compared to 21.1 months with a placebo.

Regarding safety, some studies have reported side effects. In one study, serious side effects, known as treatment-related adverse events, occurred in about 22.7% of patients. These side effects were more common than in groups not receiving atezolizumab. However, the benefits in survival and reduced risk of disease recurrence are significant.

Overall, while potential risks exist, atezolizumab has shown benefits that might outweigh these for many patients. Discussing possible side effects and benefits with a healthcare provider is important when considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for high-risk bladder cancer, which often involve a mix of surgery, chemotherapy, and radiation, atezolizumab offers a novel approach by harnessing the power of the immune system. Atezolizumab is a type of immunotherapy that works by targeting and blocking the PD-L1 protein, which can help cancer cells evade the immune system. By blocking this protein, atezolizumab allows the immune system to better recognize and attack cancer cells. Researchers are excited about this treatment because it offers the potential for a more targeted approach, possibly resulting in fewer side effects and improved outcomes for patients with high-risk bladder cancer.

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

Research shows that atezolizumab, which participants in this trial may receive, can help lower the risk of death and cancer recurrence in some patients. Studies found that this treatment reduced the chance of dying by 41% and lowered the risk of cancer returning or causing death by 36% compared to a placebo. For patients with muscle-invasive bladder cancer, atezolizumab significantly improved overall survival and extended the time patients live without the cancer worsening. These results suggest it could be effective for treating high-risk bladder cancer after surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with high-risk muscle-invasive bladder cancer who've had their bladders surgically removed and are positive for ctDNA, indicating a risk of recurrence. They should be fully recovered from surgery, have a life expectancy of at least 12 weeks, and agree to use contraception if applicable. Exclusions include active tuberculosis, severe allergies to certain substances, autoimmune diseases (with some exceptions), other recent cancer therapies or clinical trials.

Inclusion Criteria

My tumor has been tested and shows PD-L1 protein.

I have fully recovered from bladder removal surgery within the last 6 months.

My blood test shows I have cancer-related genetic changes.

Exclusion Criteria

History of severe allergic, anaphylactic, or other hypersensitivity reactions to specified substances

I have been tested and do not have active tuberculosis.

I have active hepatitis B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab or placebo intravenously on Day 1 of each 28-day cycle for up to 12 cycles or 1 year

12 months

12 visits (in-person, every 28 days)

Follow-up

Participants are monitored for disease recurrence, survival, and quality of life

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Placebo

Trial Overview The study compares the effectiveness and safety of Atezolizumab (a type of immunotherapy) against a placebo in preventing cancer recurrence after bladder removal surgery. Participants will be randomly assigned to receive either Atezolizumab or a placebo without knowing which one they're getting (double-blind).

How Is the Trial Designed?

Group I: Arm C: Surveillance Follow-Up Experimental Treatment 1 Intervention

Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter follow-up.

Group II: Arm A: Atezolizumab Experimental Treatment 2 Interventions

Atezolizumab will be administered intravenously at a dose of 1680 milligrams (mg) on Day 1 of each 28-day cycle for 12 cycles or up to 1 year (whichever occurs first). Atezolizumab will be discontinued in the event of disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.

Group III: Arm B: Placebo Placebo Group 2 Interventions

Placebo will be administered intravenously on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Natera, Inc.

Industry Sponsor

Trials

56

Recruited

50,700+

Published Research Related to This Trial

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

In a study of 115 patients with metastatic urothelial carcinoma treated with atezolizumab (ATZ) after failing first-line chemotherapy, the objective response rate was 28.7%, indicating that ATZ is effective in this patient population.

The treatment was well tolerated, with 98% of patients experiencing adverse events, but only 21.2% had severe (grade 3-4) treatment-related adverse events, suggesting a manageable safety profile similar to previous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences. Tural, D., Ölmez, ÖF., Sümbül, AT., et al.[2022]

Atezolizumab, an anti-PD-L1 therapy, showed long-term safety and efficacy in patients with metastatic urothelial carcinoma, with a median follow-up of 37.8 months and a low incidence of severe treatment-related adverse events (9%).

The treatment resulted in a 26% objective response rate, with a median duration of response of 22.1 months, and median overall survival of 10.1 months, particularly benefiting patients with higher PD-L1 expression on immune cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. Petrylak, DP., Powles, T., Bellmunt, J., et al.[2022]

In a retrospective study of 31 patients with locally advanced or metastatic bladder cancer, the combination of tislelizumab and chemotherapy (TGC) showed a median progression-free survival (PFS) of 36 weeks, significantly better than the 29 weeks observed with chemotherapy alone (GC).

While TGC treatment resulted in a higher incidence of grade ≥3 treatment-related adverse events (35.7% vs 23.5% for GC), this increase was not statistically significant, indicating that TGC is generally well tolerated while providing promising antitumor activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab in combination with gemcitabine plus cisplatin chemotherapy as first-line adjuvant treatment for locally advanced or metastatic bladder cancer: a retrospective study. Ren, X., Tian, Y., Wang, Z., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Citations

1. 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 ...

2. 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 placebo1IMvigor011 is the first ...

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1558767325001454

A Systematic Review and Meta-Analysis of the ... Following ICI therapy, the complete response (CR) rates were 36% at three months, 25% at six months, and 18% at twelve months Across all studies ...

5. 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.

6. cancertherapyadvisor.com cancertherapyadvisor.com/news/bcg-nmibc-bladder-cancer-atezolizumab-trial-results-treatment-risk/

Trial Results Reported for Atezolizumab Plus BCG in High- ... Treatment-related adverse events (TRAEs) of grade 3 or higher were reported in 8.8% of 250 patients in the BCG-only arm and in 22.7% of 255 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02792192

Study Details | NCT02792192 | Safety and Pharmacology ... This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary ...