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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: 400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Conventional Radiotherapy (Bladder only): 64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
Conventional Radiotherapy (Bladder and pelvic nodes): 64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.
Hypofractionated Radiotherapy (Bladder only): 55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin: 35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
Fluorouracil (5-FU): 5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.
Mitomycin C (MMC): MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine: Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo to Pembrolizumab: Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Bladder Intact Event-Free Survival (BI-EFS) — Up to approximately 76 months
BI-EFS is defined as the time from randomization to any of the following events: residual/recurrent MIBC post-chemoradiotherapy (CRT), nodal or distant metastases as assessed by computerized tomography (CT) and CT urography (CTU) or magnetic resonance urography (MRU) per blinded independent central review (BICR) and/or biopsy results assessed by central pathology review, radical cystectomy, or death due to any cause. If biopsy is not feasible due to participant safety, the imaging alone will be sufficient. The BI-EFS for all participants will be presented.
Trial sites (134)
| Facility | City | Region | Status |
|---|---|---|---|
| Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041) | Washington D.C. | District of Columbia | |
| Bay Pines VA Medical Center ( Site 0055) | Bay Pines | Florida | |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004) | Orlando | Florida | |
| Norton Cancer Institute ( Site 0044) | Louisville | Kentucky | |
| Pikeville Medical Center ( Site 0009) | Pikeville | Kentucky | |
| Baltimore VA Medical Center ( Site 0054) | Baltimore | Maryland | |
| Washington University ( Site 0003) | St Louis | Missouri | |
| Summit Medical Group Cancer Center ( Site 6008) | Florham Park | New Jersey | |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005) | Hackensack | New Jersey | |
| New York Oncology Hematology P.C ( Site 0024) | Albany | New York | |
| Roswell Park Cancer Institute ( Site 6009) | Buffalo | New York | |
| Winthrop University Hospital ( Site 0069) | Mineola | New York | |
| New York University Perlmutter Cancer Center ( Site 0001) | New York | New York | |
| Westchester Medical Center ( Site 6014) | Valhalla | New York | |
| Fairview Hospital-Moll Cancer Center ( Site 6013) | Cleveland | Ohio | |
| Cleveland Clinic Main ( Site 0062) | Cleveland | Ohio | |
| Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012) | Mayfield Heights | Ohio | |
| MidLantic urology ( Site 0070) | Bala-Cynwyd | Pennsylvania | |
| Saint Francis Cancer Center ( Site 0026) | Greenville | South Carolina | |
| Carolina Urologic Research Center ( Site 0002) | Myrtle Beach | South Carolina | |
| Urology San Antonio Research ( Site 6010) | San Antonio | Texas | |
| Inova Schar Cancer Institute ( Site 6006) | Fairfax | Virginia | |
| West Virginia University - Charleston Area Medical Center ( Site 6003) | Charleston | West Virginia | |
| Froedtert and Medical College of Wisconsin ( Site 0022) | Milwaukee | Wisconsin | |
| Liverpool Hospital ( Site 0220) | Liverpool | New South Wales | |
| GenesisCare North Shore ( Site 0217) | St Leonards | New South Wales | |
| Monash Medical Centre ( Site 0216) | Clayton | Victoria | |
| Austin Health ( Site 0218) | Heidelberg | Victoria | |
| Sir Charles Gairdner Hospital ( Site 0223) | Nedlands | Western Australia | |
| Oncocentro Valdivia ( Site 7055) | Valdivia | Los Ríos Region | |
| FALP ( Site 7056) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 7051) | Santiago | Region M. de Santiago | |
| ONCOCENTRO APYS-ACEREY ( Site 7054) | Viña del Mar | Valparaiso | |
| Bradford Hill Norte ( Site 7052) | Antofagasta | Chile | |
| Fakultni nemocnice Olomouc ( Site 0559) | Olomouc | Czechia | |
| 2. LF UK a FN Motol ( Site 0555) | Prague | Czechia | |
| Nemocnice Na Bulovce ( Site 0556) | Prague | Czechia | |
| Herlev og Gentofte Hospital. ( Site 0401) | Herlev | Capital Region | |
| Odense Universitetshospital ( Site 0403) | Odense | Region Syddanmark | |
| North Estonia Medical Centre Foundation ( Site 0081) | Tallinn | Harju |
+ 94 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04241185 on ClinicalTrials.gov ↗ ← All trials in Poland