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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 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- RADIATION Conventional Radiotherapy (Bladder only)
- RADIATION Conventional Radiotherapy (Bladder and pelvic nodes)
- RADIATION Hypofractionated Radiotherapy (Bladder only)
Study Locations (20)
New York
- New York Oncology Hematology P.C ( Site 0024) — Albany
- Roswell Park Cancer Institute ( Site 6009) — Buffalo
- Winthrop University Hospital ( Site 0069) — Mineola
- New York University Perlmutter Cancer Center ( Site 0001) — New York
Ohio
- Fairview Hospital-Moll Cancer Center ( Site 6013) — Cleveland
- Cleveland Clinic Main ( Site 0062) — Cleveland
- Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012) — Mayfield Heights
Florida
- Bay Pines VA Medical Center ( Site 0055) — Bay Pines
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004) — Orlando
Kentucky
- Norton Cancer Institute ( Site 0044) — Louisville
- Pikeville Medical Center ( Site 0009) — Pikeville
New Jersey
- Summit Medical Group Cancer Center ( Site 6008) — Florham Park
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005) — Hackensack
South Carolina
- Saint Francis Cancer Center ( Site 0026) — Greenville
- Carolina Urologic Research Center ( Site 0002) — Myrtle Beach
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041) — Washington D.C.
Maryland
- Baltimore VA Medical Center ( Site 0054) — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2020-05-19 |
| Est. Completion | 2031-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04241185
The ClinicalTrials.gov registry entry for NCT04241185 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04241185 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Ohio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04241185 about?
NCT04241185 is a clinical study titled "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)". 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 a...
What is the current status of trial NCT04241185?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2020-05-19. Estimated completion is 2031-11-01.
What conditions does trial NCT04241185 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04241185?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Conventional Radiotherapy (Bladder only) (RADIATION), Conventional Radiotherapy (Bladder and pelvic nodes) (RADIATION), Hypofractionated Radiotherapy (Bladder only) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04241185?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04241185 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Kentucky, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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