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)
Public ClinicalTrials.gov record NCT04241185. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04241185
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 520 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Drug
- Conventional Radiotherapy (Bladder only) Radiation
- Conventional Radiotherapy (Bladder and pelvic nodes) Radiation
- Hypofractionated Radiotherapy (Bladder only) Radiation
- Cisplatin Drug
- Fluorouracil (5-FU) Drug
- Mitomycin C (MMC) Drug
- Gemcitabine Drug
- Placebo to Pembrolizumab Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 19, 2020 (Actual)
- Primary completion
- Jan 31, 2027 (Estimated)
- Completion
- Nov 1, 2031 (Estimated)
- Last update posted
- May 1, 2026
2020 – 2031
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041) | Washington D.C. | District of Columbia | 20010 | — |
| Bay Pines VA Medical Center ( Site 0055) | Bay Pines | Florida | 33744 | — |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004) | Orlando | Florida | 32804 | — |
| Norton Cancer Institute ( Site 0044) | Louisville | Kentucky | 40207 | — |
| Pikeville Medical Center ( Site 0009) | Pikeville | Kentucky | 41501 | — |
| Baltimore VA Medical Center ( Site 0054) | Baltimore | Maryland | 21201 | — |
| Washington University ( Site 0003) | St Louis | Missouri | 63110 | — |
| Summit Medical Group Cancer Center ( Site 6008) | Florham Park | New Jersey | 07932 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005) | Hackensack | New Jersey | 07601 | — |
| New York Oncology Hematology P.C ( Site 0024) | Albany | New York | 12206 | — |
| Roswell Park Cancer Institute ( Site 6009) | Buffalo | New York | 14263 | — |
| Winthrop University Hospital ( Site 0069) | Mineola | New York | 11501 | — |
| New York University Perlmutter Cancer Center ( Site 0001) | New York | New York | 10016 | — |
| Westchester Medical Center ( Site 6014) | Valhalla | New York | 10595 | — |
| Fairview Hospital-Moll Cancer Center ( Site 6013) | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Main ( Site 0062) | Cleveland | Ohio | 44195 | — |
| Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012) | Mayfield Heights | Ohio | 44124 | — |
| MidLantic urology ( Site 0070) | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Saint Francis Cancer Center ( Site 0026) | Greenville | South Carolina | 29607 | — |
| Carolina Urologic Research Center ( Site 0002) | Myrtle Beach | South Carolina | 29572 | — |
| Urology San Antonio Research ( Site 6010) | San Antonio | Texas | 78229 | — |
| Inova Schar Cancer Institute ( Site 6006) | Fairfax | Virginia | 22031 | — |
| West Virginia University - Charleston Area Medical Center ( Site 6003) | Charleston | West Virginia | 25304 | — |
| Froedtert and Medical College of Wisconsin ( Site 0022) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 110 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04241185, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04241185 live on ClinicalTrials.gov.