TAR-200 has been formulated to continuously release a chemotherapeutic agent called gemcitabine in the bladder over several weeks.
According to TARIS Bio, TAR-200 has the potential to exhibit direct anti-tumour and immuno-oncologic activity without significant systemic drug exposure, reducing systemic side-effects.
The product secured fast track designation from the US regulatory agency for the treatment of muscle-invasive bladder cancer (MIBC) patients who are not eligible for curative-intent therapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor.
The open-label, multi-centre, single group assignment Phase Ib trial will evaluate the safety, tolerability and preliminary efficacy of the combination therapy in patients suffering from MIBC.
Up to 25 patients who are set to receive radical cystectomy will be administered TAR-200 and Opdivo on day one of four consecutive 21-day dosing cycles for a total of 84 days before the procedure.
Taris Bio chief medical officer Christopher Cutie said: “This clinical trial will be the first to evaluate the combination of the locally-administered TAR-200 system with a systemic PD-1 checkpoint inhibitor, approved for previously treated adults with advanced bladder cancer.
“We are eager to evaluate the potential antitumour and immunologic synergy of this product combination administered prior to surgery.”
The trial’s primary outcome measure is the proportion of subjects with the incidence of treatment-emergent adverse events (TEAEs) over four consecutive 21-day dosing cycles.
It will also track the number of participants not requiring treatment discontinuation before the end date due to meeting the subject stopping safety criteria or any other drug or device-related AE.
The study is expected to be completed by September next year.