# Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Source: https://onco.cc/trials/nct03711032/  
OnCo record `nct03711032` (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 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 Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) is a phase 3 interventional study registered as NCT03711032 by Merck Sharp & Dohme LLC, with 1397 participants enrolled, started 2018-12-24 and due to reach its primary completion in 2026-07-31. Interventions recorded: Pembrolizumab and BCG.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03711032
- Phase: 3
- Setting: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
- Sponsor: Merck Sharp & Dohme LLC
- Enrolled: 1397

## Sources

- ClinicalTrials.gov NCT03711032: https://clinicaltrials.gov/study/NCT03711032

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

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