Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04660344 | 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 | PHASE3 | ACTIVE NOT_RECRUITING | 761 | — | — | May 3, 2021 | Oct 1, 2026 | Mar 27, 2026 | 148 | United States, Argentina +22 |
INV-DFS, defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following: * Local (pelvic) recurrence of urothelial carcinoma (UC) (including soft tissue and regional lymph nodes); * Urinary tract recurrence of UC (including all pathological stages and grades); * Distant metastasis of UC; * Death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: Atezolizumab | EXPERIMENTAL | 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. |
| Arm B: Placebo | PLACEBO_COMPARATOR | 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. |
| Arm C: Surveillance Follow-Up | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: Inclusion Criteria for the Surveillance Phase: * Histologically confirmed MIUC (also termed transitional cell carcinoma \[TCC\]) of the bladder * Tumor, nodes, and metastases (TNM) classification (based on American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th E...