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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05200988 | Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC | PHASE2 | ACTIVE NOT_RECRUITING | 50 | — | — | Mar 14, 2022 | Sep 5, 2027 | Mar 18, 2024 | 3 | Netherlands |
| NCT03387761 | Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy | PHASE1 | COMPLETED | 54 | — | — | Jan 15, 2018 | Jan 7, 2025 | Mar 5, 2025 | 3 | Netherlands |
| NCT00362713 | Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection | PHASE1 | COMPLETED | 12 | — | — | Mar 1, 2007 | Oct 1, 2009 | Sep 30, 2016 | 1 | United States |
Events are defined as death by any cause, muscle-invasive, upper urinary tract, nodal or distant recurrence, cystectomy, or switch to cisplatin-based chemotherapy.
Percentage of patients that underwent surgery within 12 weeks after study start were assessed
| Arm | Type | Description |
|---|---|---|
| Induction with heckpoint inhibition followed by consolidative chemoradiation | EXPERIMENTAL | Checkpoint inhibition and chemoradiation |
| Cohort 1: Ipi + Nivo | EXPERIMENTAL | * Day 1: Ipilimumab 3 mg/kg i.v. * Days 22: Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg i.v. * Day 43: Nivolumab 3 mg/kg i.v. |
| Cohort 2a: high-Ipi + low-Nivo | EXPERIMENTAL | * Day 1: Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg i.v. * Days 22: Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg i.v. * Day 43: Nivolumab 3 mg/kg i.v. * Radical cystectomy or nefro/ureterectomy with appropriate lymph node dissection, day 56-84 |
| Cohort 2b: low-Ipi + high-Nivo | EXPERIMENTAL | * Day 1: Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg i.v. * Days 22: Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg i.v. * Day 43: Nivolumab 3 mg/kg i.v. * Radical cystectomy or nefro/ureterectomy with appropriate lymph node dissection, day 56-84 |
| A | EXPERIMENTAL | 3 mg/kg or 10 mg/kg |
| Name | Type | Description |
|---|---|---|
| Ipilimumab + nivolumab | DRUG | Induction with immune checkpoint blockade: ipilimumab 3mg/kg on day 1, pilimumab 3mg/kg plus nivolumab 1mg/kg on day 22, and nivolumab 3mg/kg on day 43 Response evaluation after the last cycle of checkpoint inhibition. Chemoradiation will start 10-12 weeks after start of checkpoint inhibition according to the following scheme: * Mitoycine C (12mg/m2) on the first day of radiotherapy, followed by either 5-fluorouracil intravenously (500mg/m2) five days a week during week one and four of radiation, or oral capecitabin (2x825mg/m2) every day during the radiation period * Radiation with a preference for a four-week schedule, in which 55 Gy will be administered using intensity modulated radiation therapy |
| Ipilimumab | DRUG | For Cohort 1: * Day 1: Ipilimumab 3 mg/kg * Days 22: Ipilimumab 3 mg/kg For Cohort 2a: * Day 1: Ipilimumab 3 mg/kg * Days 22: Ipilimumab 3 mg/kg For Cohort 2b: * Day 1: Ipilimumab 1 mg/kg * Days 22: Ipilimumab 1 mg/kg |
| Nivolumab | DRUG | For Cohort 1: * Day 22: Nivolumab 1 mg/kg * Day 43: Nivolumab 3 mg/kg For Cohort 2a: * Days 1 and 22: Nivolumab 1 mg/kg * Day 43: Nivolumab 3 mg/kg For Cohort 2b: \- Days 1, 22 and 43: Nivolumab 3 mg/kg |
Inclusion Criteria: 1. Willing and able to provide informed consent 2. Age ≥ 18 years 3. Patients with cT2-4aN0-2M0 urothelial bladder cancer, who are amendable for chemoradiation and who are seeking an alternative to radical cystectomy and/or patients who are medically unfit for surgery. 4. Lymph ...