NCT04831320

Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor

Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor: A Single-Arm, Phase 2 Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%). The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historical control (median PFS 3.6 months).

Conditions

• Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	Supplied by Celgene Corporation
DRUG	Nivolumab	Supplied by Bristol-Myers Squibb

Timeline

• Start date: 2021-09-28
• Primary completion: 2026-06-30
• Completion: 2027-01-31
• First posted: 2021-04-05
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study