drugset / Trial / NCT05027204

A Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Head and Neck (SCCHN)

NCT05027204 ↗

Phase 1/2 Unknown 94 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have progressed on or after platinum-based therapy.

Timeline

Start
2022-03-04
Primary completion
2023-10-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 100 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 360 mg Intravenous