# KEYNOTE-057

Source: https://onco.cc/trials/keynote-057/  
OnCo record `keynote-057` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

KEYNOTE-057 showed that pembrolizumab could clear bladder cancer confined to the lining in a substantial minority of people whose disease had stopped responding to BCG, giving the first drug alternative to removing the bladder.

## Summary

After BCG fails in high-risk non-muscle-invasive bladder cancer the standard is radical cystectomy, which many patients decline or cannot have. KEYNOTE-057 was a single-arm phase 2 study of pembrolizumab in BCG-unresponsive disease. Cohort A enrolled patients with carcinoma in situ with or without papillary tumours, with complete response rate as the primary endpoint; cohort B enrolled papillary-only high-grade disease, with disease-free survival as the endpoint.

In cohort A a substantial minority achieved a complete response at three months and about half of those responses lasted a year or more, with a systemic immunotherapy toxicity profile. Pembrolizumab was approved in the United States in January 2020 for BCG-unresponsive carcinoma in situ, the first systemic drug for this setting, followed by nadofaragene firadenovec and nogapendekin alfa inbakicept as bladder-sparing alternatives.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02625961
- Phase: 2
- Setting: High-risk non-muscle-invasive bladder cancer unresponsive to BCG in patients who decline or are unfit for cystectomy: single-arm pembrolizumab, with cohort A for carcinoma in situ and cohort B for papillary-only disease
- Sponsor: Merck & Co. (MSD)
- Enrolled: 296
- Result: Pembrolizumab produced complete responses in a substantial minority of patients with BCG-unresponsive carcinoma in situ, about half of them lasting a year or more; approved in January 2020.

## Sources

- ClinicalTrials.gov NCT02625961: https://clinicaltrials.gov/study/NCT02625961

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- people: [Arjun V. Balar](https://onco.cc/people/arjun-balar/)
- key papers: [KEYNOTE-057: pembrolizumab for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ](https://onco.cc/key-papers/paper-keynote-057-lancet-oncol-2021/)

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