Upcoming event

Overview on Keynote 57: "Phase II trial of Pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG)"

Watch the video interview with Dr. Balar on Keynote 57.

Aim of the study

To evaluate the efficacy of Pembrolizumab in patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

Primary end-points are:

Secondary end-point:

Design of the study
Single-arm phase 2 study for patients with BCG-unresponsive NMIBC who were unwilling or unfit to undergo radical cystectomy.

Patients are divided into two cohorts:

Included patients receive pembrolizumab 200mg, intravenously, every 3 weeks until one of the following events:

The efficacy of pembrolizumab is evaluated with cystoscopy and cytology ± biopsy every 3 months for the first two years, then every 6 months for other two years, then once yearly

Inclusion criteria
Patients with histologically confirmed high-risk, BCG-unresponsive NMIBC, who already received adequate BCG therapy and who refused radical cystectomy are considered eligible for this study.

BCG-unresponsive disease is defined as follows:

Main findings
The interim results for the cohort A were presented during the Challenges and Advances in Perioperative and Local Therapy for Urothelial Carcinoma session at GU ASCO 2019.