Re: Pembrolizumab Monotherapy for the Treatment of High-risk Non-muscle-invasive Bladder Cancer Unresponsive to BCG (KEYNOTE-057): An Open-label, Single-arm, Multicentre, Phase 2 Study

Experts' summary: The aim of the BRAVO study was to assess the feasibility of a randomized controlled trial (RCT) comparing intravesi-cal bacillus Calmette-Guerin (BCG) maintenance instilla-tions and radical cystectomy (RC) in high-risk, high-grade non-muscle-invasive bladder cancer (HRNMIBC). Of the 407 patients screened, 185 were eligible and approached. Of these, 50 consenting participants with HRNMIBC were randomly assigned (1:1). In the BCG arm, 92% received maintenance instillations and two patients developed metastatic bladder cancer (BC). In the RC arm, 80% under-went RC, of whom 10% had muscle-invasive BC. All of the participants were free of cancer at the end of the study. Quality of life was broadly similar in the two arms at 12 mo. The BRAVO study underlines the challenge in recruiting patients to such a clinical trial, bearing in mind the risk of undertreatment and overtreatment in HRNMIBC.

Automated summary

The BRAVO study aimed to assess the feasibility of radical cystectomy (RC) and intravesical bacillus Calmette-Guerin (BCG) maintenance instillations in high-risk, high-grade non-muscle-invasive bladder cancer (HRNMIBC) patients. The study found that all participants were free of cancer at the end and quality of life was similar in both treatment arms at 12 months. However, recruitment for such a clinical trial was challenging, considering the risks of undertreatment and overtreatment in HRNMIBC patients.