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Also known as Nivolumab, Nivolumab Injection [Opdivo], Opdivo, nivolumab, Neoadjuvant nivolumab, Nivolumab and rHuPH20, nivolumab 480mg, Nivolumab 480mg and relatlimab 160mg
Nivolumab/Ipilimumab · 3 trials · 7 indications
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
(RECIST 1.1) by CT or MRI measured at week 8 (+/- 1 week) and week 16 (+/- 1 week), 28 (+/- 1 week) and then every 12 weeks (+/- 1 week). The primary objective will be measured by the primary endpoint of ORR (based on investigator assessments) among all treated subjects, first line subjects and second line subjects. It is defined as the number of subjects with a best overall response of CR or PR divided by the number of all treated subjects, first line subjects or second line subjects. Best overall response is defined as the best response designation, as determined by investigator, recorded between the date of first dose and the date of objectively documented immunotherapy resistance per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For subjects without documented immunotherapy refractory disease or subsequent therapy, all available response designations will contribute to the ORR determination.
ORR will be assessed per cohort by an IRC according to RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Part A, Arm A: nivolumab + ipilimumab | EXPERIMENTAL | - |
| Part A, Arm B: nivolumab placebo + ipilimumab placebo | PLACEBO_COMPARATOR | - |
| Part B, Arm A: nivolumab + ipilimumab | EXPERIMENTAL | - |
| Part B, Arm B: nivolumab placebo + ipilimumab placebo | PLACEBO_COMPARATOR | - |
| Part B, Arm C: nivolumab + ipilimumab placebo | EXPERIMENTAL | - |
| Nivolumab/Ipilimumab | EXPERIMENTAL | * Induction: Mono-Therapy with Nivolumab * If CR/PR: Nivolumab Maintenance Mono-Therapy * If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy * If CR/PR: Nivolumab Maintenance Mono-Therapy * If SD/PD: Nivolumab/Ipilimumab "Boost 3+4"-Combination Therapy * If CR/PR/SD: Nivolumab Maintenance Mono-Therapy |
| Nivolumab | EXPERIMENTAL | Nivolumab 240 mg IV over 60 minutes every 14 days. |
| Name | Type | Description |
|---|---|---|
| nivolumab | BIOLOGICAL | Specified dose on specified days |
| ipilimumab | BIOLOGICAL | Specified dose on specified days |
| nivolumab placebo | DRUG | Specified dose on specified days |
| ipilimumab placebo | DRUG | Specified dose on specified days |
| Nivolumab/Ipilimumab | BIOLOGICAL | * Induction: Mono-Therapy with Nivolumab (240 mg i.V. / Q2W x 8) * If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2) * If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) * If SD/PD: Nivolumab/Ipilimumab "Boost 3+4"-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2) * If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W) |
Inclusion Criteria: * Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy * Pathologic tumor, node, and metastasis (TNM) staging meeting one of the foll...
BMS-936558, also known as nivolumab and marketed as Opdivo, is an investigational oncology drug being studied for advanced or metastatic melanoma, non-squamous cell non-small cell lung cancer, localized oesogastric adenocarcinoma, follicular lymphoma, cancer, and gastric cancer. It is developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.
BMS-936558 is a monoclonal antibody (target class -mab) that targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated across multiple oncology indications.
BMS-936558 is developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker BMY. The drug is also known as nivolumab and is marketed under the brand name Opdivo.
BMS-936558 is currently in Phase 1 clinical development. It has received FDA breakthrough therapy designation and priority review status. The drug is investigational and not yet approved, with ongoing clinical trials evaluating its safety and efficacy in various cancer types.
BMS-936558 has been studied in multiple clinical trials, including NCT02741570, a Phase 3 trial in head and neck cancer, and NCT02823574, a Phase 2 trial in the same condition. Other trials include NCT03355560 and NCT03894891, both Phase 2 studies in head and neck cancer. Across 14 trials, total enrollment is 6,828 patients.
Yes, BMS-936558 is the same as Opdivo. The drug is also known as nivolumab, nivolumab injection, and nivolumab 10 mg/ml. It is being developed by Bristol-Myers Squibb and is currently in Phase 1 trials for multiple oncology indications.