Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
An Open-Label, Single-Arm Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Ivonescimab in the Perioperative Treatment of Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (MIBC)
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pathological Complete Response (pCR) Rate
Time frame: 4 months
Secondary Endpoints
Pathological Response Rate
1-3 Year Disease-Free Survival (DFS) Rate
Recurrence-Free Survival (RFS)
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily agree to participate in the study and sign an informed consent form. 2. Male or female, aged ≥18 years. 3. Expected survival ≥12 weeks. 4. Pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC), with the primary pathological component being urothelial carcinoma ≥50%, and no upper urinary tract urothelial carcinoma. 5. Clinical staging (cT2-T4a, N0-1, M0) with no distant metastasis as evaluated by imaging. 6. Based on urologist's assessment, the subject is able to tolerate transurethral resection and radical cystectomy. 7. No prior immunotherapy, targeted therapy, or biological therapy for MIBC. Cisplatin-ineligible patients may be enrolled. 8. Cisplatin chemotherapy intolerance/non-eligibility (defined as CrCl \<60 mL/min, ≥2-grade hearing impairment, ≥2-grade peripheral neuropathy, ECOG performance status of 2). 9. Investigator-confirmed HER2 expression: IHC 1+, 2+, or 3+. 10. ECOG performance status 0-2. 11. Adequate cardiac, …
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