頭頸部扁平上皮癌におけるドセタキセル/ペムブロリズマブ

基本情報

NCT ID

NCT05252429

ステータス

実施中（募集終了）

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

27

治験依頼者名

Hokkaido University Hospital

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)