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.
Single group
Sacituzumab Govitecan + Zimberelimab
DrugSacituzumab Govitecan 7.5 mg/kg IV for 3 cycles Zimberelimab 360 mg IV for 16 cycles Patients will be treated with Sacituzumab Govitecan 1,8q21 plus + Zimberelimab q21 for 3 cycles then radiological imaging and TURB will be repeated and patients with Stability of disease or down staging will continue Zimberelimab until disease progression, or unacceptable toxicities or completion of treatment (16 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.
Event-Free Survival (EFS)
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. Patients last known to be EFS event-free are censored at the date of last event-free cystoscopy and/or CT scan. Those patients without disease assessment who are still alive will be censored at date of inclusion in the trial
clinical or pathological downstaging
Participants experiencing partial response according to RECIST v1.1 criteria and/or pathological downstaging as from pT2 to non muscle-invasive disease after SG + Zimberelimab treatment
Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs
The incidence of, causality, and outcome of AEs/SAEs. AEs will be assessed as defined by CTCAE, Version \[5.0\]
predictive role of miRNA in patients who achieve clinical or pathological downstaging after SG + Zimberelimab treatment
miRNA expression in partecipants who achieve clinical or pathological downstaging after SG + Zimberelimab treatment
predictive role of ctDNA in patients who achieve clinical or pathological downstaging after SG + Zimberelimab treatment
• ctDNA expression in partecipants who achieve clinical or pathological downstaging after SG + Zimberelimab treatment
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Gilead Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
