Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression or up to 35 cycles.

Yasushi Shimizu

Jun Taguchi

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.

Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

Phase ll Trial of Docetaxel/Pembrolizumab Combination Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Overall response rate is estimated per RECIST 1.1 by blinded independent central review (BICR).

For overall survival, the survival curve is estimated by the Kaplan-Meier method.

For progression-free survival, the survival curve is estimated by the Kaplan-Meier method.

For duration of response, the survival curve is estimated by the Kaplan-Meier method.

Drug induced toxicities are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma	NCT05252429	Effect of Drug	Docetaxel Pembrolizumab	20 Years -	Hokkaido University Hospital
Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma	NCT05252429	Effect of Drug	Docetaxel Pembrolizumab	20 Years -	Hokkaido University Hospital

Spots Global Cancer Trial Database for head and neck cancer, docetaxel, pembrolizumab