Atezolizumab for High-Risk Bladder Cancer
(IMvigor011 Trial)

Recruiting in Palo Alto (17 mi)

+261 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

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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.

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Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)
Placebo (Other)

Trial OverviewThe 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).

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: AtezolizumabExperimental Treatment1 Intervention

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 IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.

Group II: Arm B: PlaceboPlacebo Group1 Intervention

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