3상모집 중단 (진행 중)

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

연구 개요

Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body. MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments. Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors). Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works. The goal of this study is to learn: 1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT. 2. About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.

스폰서
리드: 머크(MSD)
적응증
Urinary Bladder Neoplasms
중재
Pembrolizumab, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes), Hypofractionated Radiotherapy (Bladder only), Cisplatin, Fluorouracil (5-FU), Mitomycin C (MMC), Gemcitabine, Placebo to Pembrolizumab
목표 등록
520
시작일
2020-05-19
완료(예정)
2031-11-01

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