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BI 770371とペンブロリズマブ(セツキシマブの有無にかかわらず)の併用療法が、ペンブロリズマブ単独療法と比較して頭頸部がん患者に効果があるかどうかを検証する研究

基本情報

NCT ID
NCT06806852
ステータス
募集中
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
90
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site. Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

頭頸部扁平上皮癌

介入

BI 770371(DRUG)
Pembrolizumab(DRUG)
Cetuximab(DRUG)

実施施設 (5)

関西医科大学附属病院

Osaka, Hirakata, Japan(RECRUITING)

公益財団法人がん研究会 有明病院

Tokyo, Koto-ku, Japan(RECRUITING)

神戸大学医学部附属病院

Hyogo, Kobe, Japan(NOT_YET_RECRUITING)

北海道大学病院

Hokkaido, Sapporo, Japan(NOT_YET_RECRUITING)

静岡県立静岡がんセンター

Shizuoka, Sunto-gun, Japan(RECRUITING)