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) (NCT04241185)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041) — Washington D.C., District of Columbia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (134 Sites)
Showing the first 25 of 134 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urinary Bladder Neoplasms
- A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder — Loma Linda, California
- A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer — Tucson, Arizona
- A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) — Birmingham, Alabama
- A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy — Tucson, Arizona
- A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) — Bakersfield, California
Explore by condition: All Urinary Bladder Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.