Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04282109 | Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX) | PHASE2 | COMPLETED | 141 | — | — | Jun 3, 2020 | Mar 21, 2024 | Jun 26, 2025 | 21 | Spain |
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...