Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer
NCT Number: NCT06528483
Acronym: preSAVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Bladder Cancer|Bladder Urothelial Carcinoma|Bladder Neoplasm|Muscle-Invasive Bladder Carcinoma
Interventions: DRUG: Sacituzumab Govitecan + Zimberelimab
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-02
Completion Date: 2029-12-31
Locations: Fondazione Irccs Istituto Nazionale Dei Tumori Di Milano, Milan, 20133, Italy

Summary:
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.

Primary Outcome Measures: 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, 24 months
Secondary Outcome Measures: 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, 24 months|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 \[5.0\], 24 months|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, 24 months|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, 24 months|role of 18FDG-PET in the prediction of response or relapse for N positive patients, Patients experiencing nodal progression or remission after SG + ZIM treatment, 24 months|the role of multiparametric MRI (mpMRI) in the assessment of clinical response, Patients with tumor response identified by MRI, 24 months