Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2029

Conditions
Bladder CancerMuscle-invasive Bladder Cancer
Interventions
DRUG

Disitamab Vedotin Injection

Participants will receive Disitamab Vedotin at a dose of 2.0 mg/kg. In the neoadjuvant phase, it will be administered every 2 weeks for 6 cycles (12 weeks total). In the postoperative adjuvant phase, it will be administered every 3 weeks for 4 cycles, starting 4-8 weeks after surgery.

DRUG

Ivonescimab(AK112,a PD-1/VEGF bispecific antibody)

Participants will receive Ivonescimab at a dose of 20 mg/kg. In the neoadjuvant phase, it will be administered every 3 weeks for 4 cycles (12 weeks total). In the postoperative adjuvant phase, it will be administered every 3 weeks for 9 cycles, starting 4-8 weeks after surgery.

PROCEDURE

Radical Cystectomy with Pelvic Lymph Node Dissection

Participants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose of neoadjuvant treatment.

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER