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Also known as Ipilimumab, Neoadjuvant ipilimumab, Ipilimumab-kg, Ipilimumab in, ipilimumab
Ipilimumab/ Nivolumab · 1 trial · 1 indication
The primary outcome of this study is the hazard ratio for progression-free survival (PFS), defined from the date of randomization until the date of progression (PFS truncated at subsequent systemic therapy) as determined by RECIST 1.1, or death due to any cause, whichever comes first. All attempts will be made to follow-up patients for the primary outcome measure for at least one year, even if a patient stops treatment. Patients who do not have a primary outcome event at the time of analysis will be censored on the last date the patient can be confirmed as alive and progression-free.
| Arm | Type | Description |
|---|---|---|
| Standard of Care I/N alone | ACTIVE_COMPARATOR | induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. |
| Standard of Care I/N plus primary disease SBRT | EXPERIMENTAL | induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. |
| Name | Type | Description |
|---|---|---|
| Ipilimumab/ Nivolumab | DRUG | induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression |
| SBRT + Ipilimumab/Nivolumab | RADIATION | SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. |
Inclusion Criteria: 1. Biopsy proven renal cell carcinoma of any histology. 2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening. 3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II). 4. Primary kidney lesion amenable to SBRT. 5. Eligible for st...
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.