# 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)

Source: https://onco.cc/trials/nct04241185/  
OnCo record `nct04241185` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Pembrolizumab, Cisplatin, Fluorouracil (5-FU), Mitomycin C and Gemcitabine in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

## Summary

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) is a phase 3 interventional study registered as NCT04241185 by Merck Sharp & Dohme LLC, with 520 participants enrolled, started 2020-05-19 and due to reach its primary completion in 2027-01-31. Interventions recorded: Pembrolizumab, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes), Hypofractionated Radiotherapy (Bladder only), Cisplatin and Fluorouracil (5-FU).

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04241185
- Phase: 3
- Setting: 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)
- Sponsor: Merck Sharp & Dohme LLC
- Enrolled: 520

## Sources

- ClinicalTrials.gov NCT04241185: https://clinicaltrials.gov/study/NCT04241185

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Mitomycin C](https://onco.cc/drugs/mitomycin/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

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