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

NCT05027204 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2022-10-13

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Docetaxel

Docetaxel for Injection (Albumin-bound), Q3W, i.v. 60 min

DRUG

Nivolumab

Nivolumab, Q3W, i.v. 30 min

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027204 on ClinicalTrials.gov