Patients with MIBC N0/N1 unwilling or unfit for cystectomy will receive SG + Zimberelimab for 3 cycles of treatment prior of first radiological and TURB re-evaluation.
Patients with stable disease or downstaging will continue Zimberelimab up to 1 year. The goal of this trial is to demonstate that Sacituzumab Govitecan + Zimberelimab can avoid cistectomy and can prolong or avoid recurrence to metastatic disease in selected patients with muscle-invasive bladder cancer.
The primary endpoint of this trial is Event Free Survival that is defined as clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event.
Participant is at least 18 years old of age, at the time of providing informed consent.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Patients deemed ineligible for Radical Cystectomy (RC) + Retroperitoneal lymphnode dissection (RPNLD) by a urologist and/or oncologist and/or anesthesiology.
Positive serum pregnancy test (Appendices 9.4) or women who are breastfeeding.
Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section.
Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy or targeted small molecule therapy. Patients participating in observational studies are eligible.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Gilead Sciences
Collaborator