Eligible patients for the trial have high-risk muscle-invasive bladder cancer or upper tract urothelial carcinoma (UTUC). They must have undergone a cystectomy or nephrectomy within 16 weeks. Finally, they must have pT2-4aNx or pTxN+ disease after having undergone neoadjuvant chemotherapy. Alternatively, patients can have pT3-4Nx or pN+ disease post surgery with no chemotherapy. Patients will then be stratified by PDL-1 positivity, receipt of prior neoadjuvant chemotherapy, and pathologic stage pT2/3/4aN0 vs. pT4bNx or N1-3 disease. They will then be randomized to receive 200mg of pembrolizumab every three weeks for 12 months or to observation alone. Patients will then be monitored for disease recurrence and medication tolerability. Healthcare-related quality of life outcomes will also be measured.
The primary objectives of this study are to determine the disease-free survival (DFS) and overall survival (OS) in patients with muscle-invasive bladder or upper-tract urothelial carcinoma who are treated with adjuvant pembrolizumab versus observation. Secondary endpoints include determination of safety and tolerability of pembrolizumab in patients with this disease state.
The study is clinically significant, as it will help determine if adjuvant pembrolizumab for patients with high-risk MIBC or UTUC can help reduce the risk of disease progression, RFS, and OS.
Presented by: Andrea B. Apolo, MD, National Institutes of Health, Bethesda, Maryland
Written by: Brian Kadow, MD. Society of Urologic Oncology Fellow, Fox Chase Cancer Center at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA