Bladder CancerPhase 1/2DIVONNCT06957561
Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A Phase 1/2 study testing Disitamab Vedotin Injection, Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） and Radical Cystectomy with Pelvic Lymph Node Dissection in people with Bladder Cancer and Muscle-invasive Bladder Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Muscle-invasive Bladder Cancer
- What is being tested?
- Disitamab Vedotin Injection, Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） and Radical Cystectomy with Pelvic Lymph Node Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 1 May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Clinical staging (cT2-T4a, N0-1, M0) with no distant metastasis as evaluated by imaging.
- Based on urologist's assessment, the subject is able to tolerate transurethral resection and radical cystectomy.
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- No prior immunotherapy, targeted therapy, or biological therapy for MIBC. Cisplatin-ineligible patients may be enrolled.
- Cisplatin chemotherapy intolerance/non-eligibility (defined as CrCl <60 mL/min, ≥2-grade hearing impairment, ≥2-grade peripheral neuropathy, ECOG performance status of 2).
- Investigator-confirmed HER2 expression: IHC 1+, 2+, or 3+.
- ECOG performance status 0-2.
- Adequate cardiac, bone marrow, liver, and renal function, with the following parameters meeting the criteria within 7 days prior to the first dose of study drug (normal values based on the clinical trial center):
- Left ventricular ejection fraction ≥50%;
- Hemoglobin ≥9 g/dL;
- Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;
- Platelet count ≥90 × 10^9/L;
- Total bilirubin ≤1.5 times the upper limit of normal (ULN);
- ALT and AST ≤2.5 × ULN (ALT, AST ≤5 × ULN for patients with liver metastasis);
- Serum creatinine ≤2.0 × ULN or estimated creatinine clearance (CrCl) ≥30 mL/min based on the Cockcroft-Gault formula;
- Urine protein <2+ or 24-hour urine protein <1.0g;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Female subjects must be surgically sterile, postmenopausal, or agree to use at least one medically accepted form of contraception during the study and for 6 months after the treatment period (e.g., intrauterine device, birth control pills, or condoms). A negative pregnancy test must be confirmed within 7 days prior to study enrollment, and subjects must not be breastfeeding. Male subjects must agree to use at least one medically accepted form of contraception during the study and for 6 months after the treatment period.
- Willing and able to comply with the study and follow-up procedures.
Who cannot join
- 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.
- Positive serum virology tests (based on normal values of the study center):
- 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).
- Positive HIVAb.
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- Receipt of live vaccines within 4 weeks prior to the start of study medication or plans to receive any vaccines during the study (except for the COVID-19 vaccine).
- Heart failure classified as NYHA class 3 or higher.
- Known central nervous system metastases.
- Serious arterial or venous thrombosis, or cardiovascular events such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., within 1 year before the study medication. Excluding asymptomatic lacunar infarctions that do not require clinical intervention.
- Active or progressive infections requiring systemic treatment, such as active tuberculosis.
- Systemic diseases that are not well controlled, as determined by the investigator, including diabetes, hypertension, liver cirrhosis, interstitial lung disease, obstructive lung disease, etc.
- History of serious bleeding disorders or coagulation abnormalities.
- History of gastrointestinal perforation or fistula related to anti-VEGF therapy; gastrointestinal perforation, fistula, or intra-abdominal abscess within 3 months before the first dose.
- History of esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, fistulas, bowel obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months before the first dose.
- Non-healing or poorly healing wounds, active ulcers.
- Imaging or clinical evidence of current gastrointestinal obstruction, including partial obstruction.
- Incomplete resolution of prior antitumor treatment toxicity, defined as failure to return to NCI CTCAE v5.0 Grade 0 or 1 toxicity.
- Active autoimmune disease requiring systemic treatment (e.g., immunosuppressive agents, corticosteroids, or immunomodulators) prior to the start of study medication. The use of related replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
- History of any other malignant tumors within the past 5 years, except for the following:
- Malignant tumors expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
- History of allogeneic hematopoietic stem cell transplant or organ transplant.
- Prior treatment with PD-(L)1 inhibitors or other antibody-drug conjugates.
- Known allergies to recombinant humanized anti-HER2 monoclonal antibody MMAE conjugates, PD-1/L1 monoclonal antibodies, VEGF antibodies, other monoclonal antibodies, or their components.
- Pregnant or breastfeeding women.
- Any other disease, metabolic abnormalities, abnormal physical examination, or laboratory findings that, in the investigator's judgment, may indicate a condition that is not suitable for study drug use or may affect the interpretation of study results, or place the patient at high risk.
- Estimated non-compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhuowei Liu, M.D Ph.D, +86-20-87343868, liuzhw@sysucc.org.cn
Xiangdong Li, M.D Ph.D, +86-20-87343840, lixiangd@sysucc.org.cn
About this study
Official title: 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)
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.
Read the detailed description
This open-label, single-arm Phase Ib/II clinical trial aims to assess the efficacy and safety of combining Disitamab Vedotin with Ivonescimab for treating muscle-invasive bladder cancer (MIBC) in patients who are ineligible for cisplatin-based chemotherapy. The trial consists of two primary phases: a safety run-in phase and subsequent treatment phases (neoadjuvant and postoperative adjuvant).
Study Phases:
Safety Run-In Phase:
The first 6 participants will receive an initial dose of Disitamab Vedotin (2.0 mg/kg) and Ivonescimab (20 mg/kg). If ≥2 dose-limiting toxicities (DLTs) occur, dose adjustments will be made (Disitamab Vedotin reduced to 1.5 mg/kg, Ivonescimab to 15 mg/kg). If no significant toxicity occurs, the trial will continue with the original doses.
Neoadjuvant Phase:
Participants will receive 6 cycles of Disitamab Vedotin (2.0 mg/kg, Q2W) and 4 cycles of Ivonescimab (20 mg/kg, Q3W) over 12 weeks. After treatment, patients will undergo radical cystectomy with pelvic lymph node dissection.
Postoperative Adjuvant Phase:
Following surgery, patients will receive 4 cycles of Disitamab Vedotin (2.0 mg/kg, Q3W) and 9 cycles of Ivonescimab (20 mg/kg, Q3W) to reduce the risk of recurrence.
Evaluation:
Tumor Response:
Tumor assessments will be conducted using RECIST 1.1 criteria in the neoadjuvant phase, with imaging follow-up every 12 weeks during the adjuvant phase. The primary endpoint is the objective response rate (ORR).
Biomarker Correlation:
HER2 and PD-L1 expression levels will be assessed as secondary objectives to evaluate their correlation with treatment outcomes.
Safety Monitoring and Data Management:
Adverse events will be documented and evaluated. Regular data checks will ensure the integrity and completeness of patient data. A strict confidentiality protocol will be followed, ensuring the protection of participant information.
Study Population:
Approximately 30 patients with MIBC who are ineligible for cisplatin chemotherapy will be enrolled. Inclusion criteria include documented HER2 expression and eligibility for transurethral resection and radical cystectomy.
Statistical Analysis:
Descriptive statistics will summarize baseline characteristics and treatment outcomes. Kaplan-Meier methods will be used to analyze progression-free survival (PFS) and overall survival (OS), while regression analysis will assess biomarker correlations.
Conclusion:
This trial will provide valuable insights into the potential of Disitamab Vedotin and Ivonescimab as a perioperative treatment for cisplatin-ineligible MIBC patients, offering a new therapeutic option for this challenging patient population.
- Conditions
- Bladder Cancer, Muscle-invasive Bladder Cancer
- Being tested
- Disitamab Vedotin Injection, Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）, Radical Cystectomy with Pelvic Lymph Node Dissection
- Keywords
- Cisplatin-Ineligible, Muscle-invasive bladder cancer, Disitamab Vedotin, Ivonescimab, Perioperative treatment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin InjectionDrug
Also called RC48-ADC
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
Also called AK112
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 DissectionProcedure or surgery
Participants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose of neoadjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Combined with Ivonescimab | Experimental | 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. Receives: Drug: Disitamab Vedotin Injection; Drug: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）; Procedure: Radical Cystectomy with Pelvic Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (5)
Pathological Response Rate
The percentage of patients with pathological complete response (pT0N0) or pathological partial response (≤ ypT1N0M0) during surgery.
Measured: 4 months
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.
Measured: Up to 3 years
Recurrence-Free Survival (RFS)
The rate of recurrence of the disease after completion of treatment as confirmed by imaging or clinical evidence.
Measured: Up to first recurrence of disease or up to 5 years
Overall Survival (OS)
The time from the first dose of neoadjuvant treatment to death from any cause.
Measured: Up to death or up to 5 years
Clinical Objective Response Rate (ORR)
Tumor evaluations will be conducted according to RECIST 1.1 criteria for all patients with evaluable lesions at baseline, and responses will be assessed at each tumor assessment.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start30 Apr 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Zhuowei Liu, M.D Ph.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957561
- Sponsor's protocol ID
- B2025-094-01
- Acronym
- DIVON
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06957561
- Acronym / sponsor ID
- DIVON / B2025-094-01
- Conditions
- Bladder Cancer, Muscle-invasive Bladder Cancer
- Keywords
- Cisplatin-Ineligible, Muscle-invasive bladder cancer, Disitamab Vedotin, Ivonescimab, Perioperative treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This open-label, single-arm Phase Ib/II clinical trial aims to assess the efficacy and safety of combining Disitamab Vedotin with Ivonescimab for treating muscle-invasive bladder cancer (MIBC) in patients who are ineligible for cisplatin-based chemotherapy. The trial consists of two primary phases: a safety run-in phase and subsequent treatment phases (neoadjuvant and postoperative adjuvant).
Study Phases:
Safety Run-In Phase:
The first 6 participants will receive an initial dose of Disitamab Vedotin (2.0 mg/kg) and Ivonescimab (20 mg/kg). If ≥2 dose-limiting toxicities (DLTs) occur, dose adjustments will be made (Disitamab Vedotin reduced to 1.5 mg/kg, Ivonescimab to 15 mg/kg). If no significant toxicity occurs, the trial will continue with the original doses.
Neoadjuvant Phase:
Participants will receive 6 cycles of Disitamab Vedotin (2.0 mg/kg, Q2W) and 4 cycles of Ivonescimab (20 mg/kg, Q3W) over 12 weeks. After treatment, patients will undergo radical cystectomy with pelvic lymph node dissection.
Postoperative Adjuvant Phase:
Following surgery, patients will receive 4 cycles of Disitamab Vedotin (2.0 mg/kg, Q3W) and 9 cycles of Ivonescimab (20 mg/kg, Q3W) to reduce the risk of recurrence.
Evaluation:
Tumor Response:
Tumor assessments will be conducted using RECIST 1.1 criteria in the neoadjuvant phase, with imaging follow-up every 12 weeks during the adjuvant phase. The primary endpoint is the objective response rate (ORR).
Biomarker Correlation:
HER2 and PD-L1 expression levels will be assessed as secondary objectives to evaluate their correlation with treatment outcomes.
Safety Monitoring and Data Management:
Adverse events will be documented and evaluated. Regular data checks will ensure the integrity and completeness of patient data. A strict confidentiality protocol will be followed, ensuring the protection of participant information.
Study Population:
Approximately 30 patients with MIBC who are ineligible for cisplatin chemotherapy will be enrolled. Inclusion criteria include documented HER2 expression and eligibility for transurethral resection and radical cystectomy.
Statistical Analysis:
Descriptive statistics will summarize baseline characteristics and treatment outcomes. Kaplan-Meier methods will be used to analyze progression-free survival (PFS) and overall survival (OS), while regression analysis will assess biomarker correlations.
Conclusion:
This trial will provide valuable insights into the potential of Disitamab Vedotin and Ivonescimab as a perioperative treatment for cisplatin-ineligible MIBC patients, offering a new therapeutic option for this challenging patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Combined with Ivonescimab | Experimental | Drug: Disitamab Vedotin Injection, Drug: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）, Procedure: Radical Cystectomy with Pelvic Lymph Node DissectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- Clinical staging (cT2-T4a, N0-1, M0) with no distant metastasis as evaluated by imaging.
Key exclusion criteria (27 listed)
- 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.
- Positive serum virology tests (based on normal values of the study center):
- Receipt of live vaccines within 4 weeks prior to the start of study medication or plans to receive any vaccines during the study (except for the COVID-19 vaccine).
- Heart failure classified as NYHA class 3 or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab Vedotin InjectionAlso: RC48-ADCParticipants 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 | Disitamab Vedotin Combined with Ivonescimab |
| Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）Also: AK112Participants 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. | Drug | Disitamab Vedotin Combined with Ivonescimab |
| Radical Cystectomy with Pelvic Lymph Node DissectionParticipants will undergo radical cystectomy with pelvic lymph node dissection 4-6 weeks after the last dose of neoadjuvant treatment. | Procedure or surgery | Disitamab Vedotin Combined with Ivonescimab |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: 4 months
The percentage of patients who achieve a pathological complete response (pT0N0) after surgery following neoadjuvant treatment with Disitamab Vedotin combined with Ivonescimab.
5 secondary outcomes
Pathological Response Rate
Time frame: 4 months
1-3 Year Disease-Free Survival (DFS) Rate
Time frame: Up to 3 years
Recurrence-Free Survival (RFS)
Time frame: Up to first recurrence of disease or up to 5 years
Overall Survival (OS)
Time frame: Up to death or up to 5 years
Clinical Objective Response Rate (ORR)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuowei Liu, M.D Ph.D principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Disitamab Vedotin Injection, Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） and Radical Cystectomy with Pelvic Lymph Node Dissection in people with Bladder Cancer and Muscle-invasive Bladder Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuowei Liu, M.D Ph.D (+86-20-87343868, liuzhw@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.