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

Sponsor
Sun Yat-sen University
Study ID
NCT06957561
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Disitamab Vedotin Injection — DRUG
    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.
  • Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） — DRUG
    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.
  • Radical Cystectomy with Pelvic Lymph Node Dissection — PROCEDURE
    Participants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose of neoadjuvant treatment.

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
May 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Disitamab Vedotin Combined with Ivonescimab
    Participants will receive Disitamab Vedotin (2.0 mg/kg, every 2 weeks) for 6 cycles, combined with Ivonescimab (20 mg/kg, every 3 weeks) for 4 cycles, with a total duration of 12 weeks for the neoadjuvant treatment phase. Following the completion of neoadjuvant therapy, participants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose. In the postoperative adjuvant phase, participants will receive Disitamab Vedotin (2.0 mg/kg, every 3 weeks, for 4 cycles) combined with Ivonescimab (20 mg/kg, every 3 weeks, for 9 cycles), starting 4-8 weeks after surgery.

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: 4 months ]

Central Contacts

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