Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nivolumab, Nivolumab Injection [Opdivo], Opdivo, nivolumab, Neoadjuvant nivolumab, Nivolumab and rHuPH20, nivolumab 480mg, Nivolumab 480mg and relatlimab 160mg
Nivolumab+ Paclitaxel · 1 trial · 1 indication
OS is defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | NIVOTAX (nivolumab + paclitaxel, follow by maintenance with nivolumab) |
| Arm 2 | ACTIVE_COMPARATOR | ERBITAX (cetuximab + paclitaxel, follow by maintenance with cetuximab) |
| Name | Type | Description |
|---|---|---|
| Nivolumab + Paclitaxel | DRUG | Combination treatment: Nivolumab 240 mg will be administered via IV infusion every 2 weeks. Paclitaxel 80mg/m2 will be administered via IV infusion weekly. After 12 weeks from the start of the combined treatment paclitaxel will be stopped. Maintenance treatment with nivolumab 480 mg every 4 weeks will start two weeks after the last administration of nivolumab 240 mg. Once nivolumab is administered at 480 mg, paclitaxel can no longer be administered. Nivolumab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months. |
| Cetuximab + Paclitaxel | DRUG | Combination treatment: Cetuximab 250 mg/m2 (first dose of 400 mg/m2) administered via IV infusion weekly plus weekly paclitaxel (80 mg/m2) administered via IV infusion. After 12 weeks from the start of the combined treatment paclitaxel will be stopped and weekly cetuximab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months. |
Inclusion Criteria: 1. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. 2. Histologically confirmed HNSCC (oral cavity, oropharynx, hypopharynx, larynx) not amenable to therapy with curative intent (surgery or radiation the...
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.