VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer

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.

Timeline

Start

2015-09-08

Primary completion

2019-10-22

Completion

2023-03-07

Publications

• Rentsch CA, Thalmann GN, Lucca I, Kwiatkowski M, Wirth GJ, Strebel RT, Engeler D, Pedrazzini A, Huttenbrink C, Schultze-Seemann W, Torpai R, Bubendorf L, Wicki A, Roth B, Bosshard P, Puschel H, Boll DT, Hefermehl L, Roghmann F, Gierth M, Ribi K, Schafer S, Hayoz S. A Phase 1/2 Single-arm Clinical Trial of Recombinant Bacillus Calmette-Guerin (BCG) VPM1002BC Immunotherapy in Non-muscle-invasive Bladder Cancer Recurrence After Conventional BCG Therapy: SAKK 06/14. Eur Urol Oncol. 2022 Apr;5(2):195-202. doi: 10.1016/j.euo.2021.12.006. Epub 2022 Jan 7.

Drugs

Indications