NCT06623162

Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients

Selective Bladder-Sparing Trial with Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fundación de investigación HM · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients

Detailed description

All patients will receive 4 cycles of gemcitabine plus cisplatin followed by clinical restaging (Fig.1). After neoadjuvant chemotherapy, patients will be restaged and patients achieving a clinical response (normal cytology, imaging, and cT0/Ta/T1/Tis) will be eligible to proceed without cystectomy and receive maintenance with sasanlimab 300 mg subcutaneous (two product presentations: a vial and a prefilled syringe) every 4 weeks (Q4W) for up to 12 cycles initiating between 3-6 weeks and followed by surveillance (Fig.1). Treatment may be discontinued in case of progression, unacceptable toxicity, patient withdrawal or death. Patients with persistent non-muscle invasive disease (cTa/T1/Tis) at the first evaluation at 12 weeks of maintenance ( after 3 cycles of sasanlimab), will be recommended to undergo cystectomy. Non clinically responding patients (≥ T2) after neoadjuvant chemotherapy will undergo cystectomy (Fig.1). Patients may undergo late cystectomy throughout the study period in the case of local relapse, following the investigator criteria or according to the patient\'s choice.

Conditions

• Mibc
• Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine + cisplatine	4 cycles

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-10-02
• Last updated: 2024-10-04

Locations

1 site across 1 country: Spain