VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This phase I/II trial will assess the safety and efficacy of intravesical instillation of
VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB
(transurethral resection of the bladder) and standard BCG therapy. In phase I part of the
trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II
dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D
to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of
VPM1002BC will be compared to results previously reported for BCG in a similar population.
The quality of life will be also investigated as a secondary endpoint. Additional immunology
assessments are foreseen as exploratory analyses to investigate the immunogenicity of
VPM1002BC.
The Phase II of the trial has been opened on 27.07.2016.