頭頸部癌患者におけるアミバンタマブ単独または他の治療薬との併用療法の研究

基本情報

NCT ID: NCT06385080
ステータス: 募集中
試験のフェーズ: 第1/第2相
試験タイプ: 介入
目標被験者数: 287
治験依頼者名: Janssen Research & Development, LLC

概要

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

対象疾患

頭頸部扁平上皮癌

介入

Amivantamab(BIOLOGICAL)

Pembrolizumab(BIOLOGICAL)

Paclitaxel(DRUG)

Carboplatin(DRUG)

依頼者（Sponsor）

ヤンセンファーマ株式会社(INDUSTRY)

実施施設 (2)

愛知県がんセンター

Nagoya, Japan(RECRUITING)

東京医科大学病院

Tokyo, Japan(RECRUITING)