Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily agree to participate in the study and sign an informed consent form.
Male or female, aged ≥18 years.
Expected survival ≥12 weeks.
Pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC), with the primary pathological component being urothelial carcinoma ≥50%, and no upper urinary tract urothelial carcinoma.
Disqualifiers
Prior systemic antitumor treatment, other than cisplatin, such as targeted therapy, immunotherapy, or biological therapy, before the start of study medication.
Major surgery within 4 weeks prior to the start of study medication.
HBsAg or HBcAb positive, with positive HBV DNA copy number.
Positive HCVAb (only if HCV RNA PCR test is negative, the subject may be eligible).
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab Vedotin Injection
DrugParticipants 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）
DrugParticipants 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/SurgeryParticipants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose of neoadjuvant treatment.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Disitamab Vedotin Combined with IvonescimabExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR) Rate
The percentage of patients who achieve a pathological complete response (pT0N0) after surgery following neoadjuvant treatment with Disitamab Vedotin combined with Ivonescimab.
Time frame
4 monthsSecondary outcomes
1
Pathological Response Rate
The percentage of patients with pathological complete response (pT0N0) or pathological partial response (≤ ypT1N0M0) during surgery.
Time frame
4 months2
1-3 Year Disease-Free Survival (DFS) Rate
The percentage of patients who remain free from local or distant recurrence, or death from any cause, as confirmed by imaging or pathological examination, at 1, 2, or 3 years after surgery.
Time frame
Up to 3 years3
Recurrence-Free Survival (RFS)
The rate of recurrence of the disease after completion of treatment as confirmed by imaging or clinical evidence.
Time frame
Up to first recurrence of disease or up to 5 years4
Overall Survival (OS)
The time from the first dose of neoadjuvant treatment to death from any cause.
Time frame
Up to death or up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov
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