MedTrace Logo

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

NCT06957561 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-04

No results posted yet for this study

Summary

This is a single-arm, open-label, Phase Ib/II clinical trial designed to evaluate the efficacy and safety of Disitamab Vedotin combined with Ivonescimab in the perioperative treatment of cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). The study will enroll MIBC patients scheduled for radical cystectomy who have not received prior immunotherapy, targeted therapy, or biological therapy, except for cisplatin chemotherapy. The trial will consist of a neoadjuvant treatment phase (Disitamab Vedotin and Ivonescimab), followed by surgery and an adjuvant treatment phase. Primary efficacy endpoints include the pathological complete response (pCR) rate, while secondary endpoints include disease-free survival, recurrence-free survival, overall survival, and clinical objective response rate. Safety will be monitored throughout the study, and biomarker testing (HER2 and PD-L1) will be conducted to assess treatment efficacy. The study aims to explore the potential of this combination therapy in improving outcomes for MIBC patients.

Conditions

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Zhuowei Liu, M.D Ph.D · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-05-01
Completion
2029-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06957561 on ClinicalTrials.gov