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Also known as Ipilimumab, Neoadjuvant ipilimumab, Ipilimumab-kg, Ipilimumab in, ipilimumab
Ipilimumab and Fotemustine · 1 trial · 1 indication
Immune-related Disease Control Rate (irDCR) is the proportion of treated subjects with a BOR of confirmed irCR, confirmed irPR or irSD. Tumor assessment (including determination of overall response at each tumor assessment and best overall response (BOR) taken over all tumor assessments prior to subsequent therapy is performed using the immune-related (ir) tumor response criteria.
| Arm | Type | Description |
|---|---|---|
| Single arm of ipilimumab and fotemustine | EXPERIMENTAL | Ipilimumab in combination with Fotemustine |
| Name | Type | Description |
|---|---|---|
| Ipilimumab and Fotemustine | DRUG | Ipilimumab: 10 mg/kg q3 weeks for 4 doses, q12 weeks starting at Week 24 Fotemustine: 100 mg/m2 q1 week for 3 doses, q3 weeks starting at Week 9 |
Inclusion Criteria: * Histologic diagnosis of malignant melanoma * Stage III (unresectable) or Stage IV melanoma * Maximum 1 line of chemotherapy for advanced disease allowed * No prior chemotherapy within 4 weeks from treatment start (6 weeks in case of nitrosourea) * No previous systemic corticos...
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.