Pembrolizumab in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Status:
Terminated
Trial end date:
2019-06-26
Target enrollment:
Participant gender:
Summary
A parallel group, open label, multi-centre, phase I/II marker-lesion study of intravesical or
intravenous pembrolizumab in recurrent intermediate risk NMIBC. Thirty patients (fifteen in
each of two arms) will be randomised 1:1 to treatment with either intravesical pembrolizumab
(Arm A) or intravenous pembrolizumab (Arm B). The main study will be preceded by a single
institution safety run-in phase involving intra-patient dose escalation in six patients to
confirm the safety and tolerability of intravesical pembrolizumab and the dose to be used in
the randomised phase.