NCT06133517

PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer

An Open Label, Single-arm, Phase 2 Study of Perioperative Sacituzumab Govitecan in Combination With Zimberelimab and Domvanalimab for Patients With Muscle Invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fundación para el Progreso de la Oncología en Cantabria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to evaluate the efficacy of the combo Sacituzumab govitecan (SG) + Zimberelimab (AB 122) (ZIM) + Domvanalimab (AB 154) (DOM), measured as pathologic complete response (pCR) rates, in the perioperative setting in patients with Muscle Invasive Bladder Cancer (MIBC) who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy.

Detailed description

This is an open label, multicenter, single arm, phase II clinical trial, which aims to evaluate the effects of perioperative treatment with sacituzumab govitecan, zimberelimab and domvanalimab in patients with confirmed histological diagnosis of urothelial bladder carcinoma pT2-T4a cN0-1 cM0 non-eligible or who refuse to receive cisplatin-based neoadjuvant chemotherapy. Patients who are eligible to participate in the study will receive 3 cycles of sacituzumab govitecan, zimberelimab and domvanalimab every 3 weeks prior to cystectomy, unless there are signs of unacceptable toxicity, progressive disease or the patient requests withdrawal from the study. Patients who do not achieve a pCR or that achieving a pCR still have positive ctDNA will also complete an adjuvant phase of the study consisting of 12 additional cycles of zimberelimab and domvanalimab. To progressively test the safety of the proposed combination, this study has been developed in two stages with the aim of preserving patient's safety as a priority. This study includes a preliminary assessment about the safety of the combinations. Thus, there will be a safety run-in period in which 8 patients will receive the SG+ZIM combination to confirm the tolerability of this doublet in patients with MIBC. Once the safety of this doublet has been confirmed by an external safety committee then the study will proceed to an additional safety-run in cohort with the triplet.

Conditions

• Urothelial Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	Sacituzumab govitecan is administered at 10 mg/kg as an intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle.
DRUG	Zimberelimab	ZIM is administered at 360 mg every 3 weeks as an intravenous (IV) infusion on Day 1 of a 21-day cycle.
DRUG	Domvanalimab	DOM is administered at 1200 mg every 3 weeks as an intravenous (IV) infusion on Day 1 of a 21-day cycle.

Timeline

• Start date: 2025-01-20
• Primary completion: 2030-01-01
• Completion: 2030-12-01
• First posted: 2023-11-15
• Last updated: 2026-03-16

Locations

6 sites across 1 country: Spain