Trial results for the NIVOTAX study (NCT04282109) investigating nivolumab in combination with paclitaxel for recurrent/metastatic head and neck squamous cell carcinoma were posted on ClinicalTrials.gov on 2025-06-26. The study showed that the nivolumab combination achieved a 2-year overall survival rate of 24.7% compared to 13.4% for the comparator arm.
Background
The NIVOTAX study aimed to assess the efficacy and safety of nivolumab in combination with paclitaxel for subjects with recurrent or metastatic head and neck squamous cell carcinoma who were unable to receive cisplatin-based chemotherapy. This patient population often presents with poor physical condition, making platinum-based chemotherapy unsuitable. The study explored an alternative regimen compared to the standard of care, which often includes paclitaxel in combination with cetuximab.
Trial design
The NIVOTAX study (NCT04282109) was a Phase 2, completed trial that enrolled 141 participants. The study investigated treatments for recurrent/metastatic head and neck squamous cell carcinoma. Participants were assigned to one of two intervention arms: nivolumab + paclitaxel (Arm 1) or cetuximab + paclitaxel (Arm 2).
Key results
The trial results provided several key measurements for both treatment arms:
- For Two Years Overall Survival (OS):
- Arm 1 (nivolumab + paclitaxel) achieved 24.7% of participants.
- Arm 2 (cetuximab + paclitaxel) achieved 13.4% of participants.
- For Progression Free Survival (PFS):
- Arm 1 (nivolumab + paclitaxel) had a median of 5.6 months.
- Arm 2 (cetuximab + paclitaxel) had a median of 5.3 months.
- For Overall Response Rate (ORR):
- Arm 1 (nivolumab + paclitaxel) was 37.6% of participants.
- Arm 2 (cetuximab + paclitaxel) was 37.5% of participants.
- For Disease Control Rate (DCR):
- Arm 1 (nivolumab + paclitaxel) was 74.2% of participants.
- Arm 2 (cetuximab + paclitaxel) was 79.2% of participants.
- For Duration of Response (DoR):
- Arm 1 (nivolumab + paclitaxel) had a median of 9 months.
- Arm 2 (cetuximab + paclitaxel) had a median of 7.6 months.
- For 6-months Progression-free Survival Rate:
- Arm 1 (nivolumab + paclitaxel) was 47.5% of participants.
- Arm 2 (cetuximab + paclitaxel) was 50.0% of participants.
What this means
The results of the NIVOTAX study suggest that the combination of nivolumab and paclitaxel may offer an improved 2-year overall survival rate compared to cetuximab and paclitaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma who cannot tolerate cisplatin-based chemotherapy. While other metrics like Overall Response Rate were similar, and Disease Control Rate and 6-month PFS were slightly lower for the nivolumab arm, the notable difference in 2-year overall survival and Duration of Response indicates a potential benefit for this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04282109, titled "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)," were posted on 2025-06-26 on clinicaltrials.gov.