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Also known as Ipilimumab, Neoadjuvant ipilimumab, Ipilimumab-kg, Ipilimumab in, ipilimumab
Ipilimumab+ nivolumab · 3 trials · 2 indications
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 ...
Ipilimumab is an investigational monoclonal antibody being studied for multiple cancers, including advanced melanoma, advanced biliary tract cancer, metastatic colorectal cancer, lung cancer, renal cancer, and pancreatic cancer. It is currently in Phase 2 clinical development for these oncology indications.
Ipilimumab is a monoclonal antibody (mab) that targets CTLA-4, a protein on T cells that acts as a checkpoint to regulate immune responses. By blocking CTLA-4, ipilimumab is designed to enhance the body's immune system to attack cancer cells.
Ipilimumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Ipilimumab is currently in Phase 2 clinical development. While some completed trials have been conducted in earlier phases, the drug remains investigational and has not been approved by regulatory authorities for any indication.
Ipilimumab has been studied in multiple clinical trials, including NCT00527735 for lung cancer, NCT01585987 for gastric cancer, NCT02279732 for non-small cell lung cancer, and NCT04141644 for EGFR-mutated NSCLC. These trials have explored the drug alone or in combination with other therapies.
Ipilimumab is the single-agent drug, while Ipilimumab plus nivolumab refers to a combination regimen. The drug is also known by several names, including neoadjuvant ipilimumab, ipilimumab/nivolumab, and ipilimumab 3mg/kg and nivolumab 1mg/kg, reflecting different dosing schedules.