drugset
drugset / Trial / 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

NCT04831320 ↗

Phase 2 Active not recruiting 46 enrolled Washington University School of Medicine Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-09-28
Primary completion
2027-06-30
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous

Indications

head and neck squamous cell carcinoma