A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy

Conditions

• Muscle-invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
• Placebo — OTHER
  ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle
• Signatera — DEVICE
  Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up.

Study Details

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 circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.

Key Dates

Start date

May 3, 2021

Status verified

Mar 2026

Primary completion

Jun 15, 2025

Completion

Oct 1, 2026

Study Design

Enrollment

761 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Atezolizumab
  Atezolizumab will be administered intravenously (IV) 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.
• Placebo Comparator: Arm B: Placebo
  Placebo will be administered IV 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. Following the primary analysis, participants randomized to the comparator arm might discontinue placebo and may receive treatment outside the study at the investigator's discretion.
• Experimental: Arm C: Surveillance Follow-Up
  Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up.

Primary Outcome Measure

Investigator-assessed (INV) - Disease-free Survival (DFS) [ Time Frame: Randomization up to first occurrence of DFS event (up to approximately 49 months) ]

Locations (4)

Related coverage on Hipa.ai

• Atezolizumab Phase 3 Trial for MIBC Reaches Primary Completion
  Atezolizumab · Jun 15, 2025 · ClinicalTrials.gov

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