# 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** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Merck Sharp & Dohme LLC** · enrollment: 520 (estimated)

## Conditions studied

- Urinary Bladder Neoplasms

## Interventions

- **DRUG:** Pembrolizumab
- **RADIATION:** Conventional Radiotherapy (Bladder only)
- **RADIATION:** Conventional Radiotherapy (Bladder and pelvic nodes)
- **RADIATION:** Hypofractionated Radiotherapy (Bladder only)
- **DRUG:** Cisplatin
- **DRUG:** Fluorouracil (5-FU)
- **DRUG:** Mitomycin C (MMC)
- **DRUG:** Gemcitabine
- **DRUG:** Placebo to Pembrolizumab

## Key facts

- **NCT ID:** NCT04241185
- **Lead sponsor:** Merck Sharp & Dohme LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-05-19
- **Primary completion:** 2027-01-31
- **Final completion:** 2031-11-01
- **Target enrollment:** 520 (ESTIMATED)
- **Last updated:** 2026-05-01


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04241185, "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)". Retrieved via AI Analytics 2026-07-16 from https://api.ai-analytics.org/clinical/NCT04241185. Licensed CC0.

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