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Also known as Ipilimumab, Neoadjuvant ipilimumab, Ipilimumab-kg, Ipilimumab in, ipilimumab
Ipilimumab/kg and nivolumab/kg · 1 trial · 2 indications
The primary endpoint is the pathological response rate at surgery (between days 43 and 56) from the first dose of neoadjuvant study treatment for each of cohorts 1b, 2 and 3. The pathological response is categorised thus: - Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen - Near complete pathological response - (near pCR) - \<10% viable tumour - Partial pathological response (pPR) - 10%-50% viable tumour - No pathological response (pNR) - \>50% viable tumour The proportion of participants with a pCR, or near pCR will determine the pathological response rate.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | EXPERIMENTAL | Ipilimumab at 3 mg per kg with nivolumab at 1 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses. |
| Treatment Arm B | EXPERIMENTAL | Ipilimumab 1mg per kg and the fixed dose combination nivolumab 480 mg and relatlimab 160 mg will be administered on days 1 and 29 (Q4W) for a total of 2 doses. |
| Treatment Arm C | EXPERIMENTAL | Fixed dose combination of nivolumab 480 mg and relatlimab 160 mg alone, to be administered on days 1 and 29 (Q4W) for a total of 2 doses. |
| Treatment Arm D (Cohort 1a) | ACTIVE_COMPARATOR | Ipilimumab at 1 mg per kg with nivolumab at 3 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses. |
| Treatment Arm E (Cohort 1b) | ACTIVE_COMPARATOR | Ipilimumab at 1 mg per kg with nivolumab at 3 mg per kg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses. |
| Treatment Arm F | ACTIVE_COMPARATOR | Pembrolizumab 200 mg will be administered on days 1 and 22 (Q3W) in the neoadjuvant period for a total of 2 doses |
| Name | Type | Description |
|---|---|---|
| Ipilimumab 3mg/kg and nivolumab 1mg/kg | DRUG | Neoadjuvant for 2 doses on days 1 and 22 |
| Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg | DRUG | Neoadjuvant for 2 doses at days 1 and 29 |
| Nivolumab 480mg and relatlimab 160mg | DRUG | Neoadjuvant for 2 doses on days 1 and 29 |
| Ipilimumab 1mg/kg and nivolumab 3mg/kg | DRUG | Neoadjuvant for 2 doses at days 1 and 22 |
| Pembrolizumab 200 mg | DRUG | Neoadjuvant for 2 doses at days 1 and 22 |
COMMON Inclusion Criteria Applicable to all 3 cohorts Inclusion Criteria: * 1\. Written informed consent * 2\. Male or female patients who are at least 18 years of age on the day of signing informed consent. * 3\. Clinically detectable disease, and/or RECIST version 1.1 defined disease, and/or dis...
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.