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PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer

NCT06133517 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Urothelial Bladder Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Fundación para el Progreso de la Oncología en Cantabria

    lead OTHER

Principal Investigators

  • Ignacio Duran, MD · Hospital Universitario Marqués de Valdecilla

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2030-01-31
Completion
2030-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133517 on ClinicalTrials.gov