Status:
Open
Clinicaltrials.gov identifier:
Sponsor:
National Cancer Institute (NCI)
Enrollment:
739
Study Design:
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, have pT2-4aNx or pTxN+ disease after having undergone neoadjuvant chemotherapy. Patients can have pT3-4Nx or pN+ disease post surgery with no chemotherapy. Patients are stratified by PD-L1 positivity, receipt of prior neoadjuvant chemotherapy, and pathologic stage pT2/3/4aN0 vs. pT4bNx or N1-3 disease. They are then randomized to receive 200mg of pembrolizumab every three weeks for 12 months or to observation. Healthcare-related quality of life outcomes will also be measured.
Rationale:
As mentioned in the two adjuvant trials above, there is not enough clinical trial evidence supporting adjuvant therapy in high risk MIUC. Similar to the two trials described above, this trial aims to evaluate pembrolizumab, a PD-1 immune checkpoint inhibitor, approved as monotherapy for treatment of platinum-resistant metastatic UC and platinum ineligible patients as well as in NMIBC patient who have failed BCG, as adjuvant therapy in patients with high-risk MIUC.
Endpoints:
The primary objectives of this study are to determine overall survival (OS) and DFS
Comments:
It is hoped that this study will finish its accrual after presentation of the positive adjuvant Nivolumab trial.
Results:
Still accruing
