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Spots Global Cancer Trial Database for Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

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Trial Identification

Brief Title: Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

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

Study ID: NCT05252429

Conditions

Effect of Drug

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

Contact Details

Name: Yasushi Shimizu

Affiliation: Hokkaido University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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