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Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

NCT05252429 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-09-12

No results posted yet for this study

Summary

Pembrolizumab monotherapy and platinum-based chemotherapy in the combination with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been widely used in daily clinical practice based on the KEYNOTE-048 study. On the other hand, docetaxel is a commonly used antimitotic agent in cancer therapy and might have potent antitumor effect by the immune response. A combination therapy of docetaxel and pembrolizumab might be a promising treatment for R/M HNSCC. The KEYNOTE-048 study showed that pembrolizumab plus platinum and 5-fluorouracil is a tolerable treatment for R/M HNSCC. The main grade 3/4 adverse event of platinum and 5-fluorouracil was myelosuppression such as neutropenia similar to docetaxel in some studies for R/M HNSCC. The safety profile of platinum and 5-fluorouracil is not much different from docetaxel. Therefore, docetaxel/pembrolizumab combination treatment might also be tolerable. The hypothesis of this study is that a combination therapy of docetaxel and pembrolizumab will provide benefit for patients with R/M HNSCC.

Conditions

  • Effect of Drug

Interventions

DRUG

Docetaxel

Docetaxel 75mg/m2; q21

DRUG

Pembrolizumab

Pembrolizumab 200mg, q21

Sponsors & Collaborators

Principal Investigators

  • Yasushi Shimizu · Hokkaido University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2025-05-31
Completion
2025-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT05252429 on ClinicalTrials.gov