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New treatment option for Muscle Invasive Bladder Cancer (MIBC)
Official title Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
ClinicalTrials.gov ID: NCT07296705
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for muscle invasive bladder cancer (mibc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment...
- Age 18 to 85 years on the date of informed consent.
- Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and...
- Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
- HER2-positive: IHC 2+ or 3+.
You likely can't join if
- Pregnant or breastfeeding women.
- Uncontrolled infection requiring systemic therapy.
- Diagnosis of another malignancy within the past 5 years.
- Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major...
- Prior radiotherapy to the bladder for bladder cancer.
- Active autoimmune disease requiring systemic treatment that, in the investigator's judgment, would affect study therapy.
See the full eligibility criteria
- Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.
- Age 18 to 85 years on the date of informed consent.
- Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be...
- Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
- HER2-positive: IHC 2+ or 3+.
- No prior anti-HER2-directed therapy (including but not limited to HER2 antibodies, HER2-targeting ADCs, or HER2-targeted TKIs) and no prior PD-(L)1 therapy.
- ECOG performance status 0-2.
- Adequate organ function based on screening labs obtained ≤14 days before enrollment: a. For the following counts, no growth-factor support within 14 days prior to sample collection: i. Absolute neutrophil count ≥ 1.5 ×...
- Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days before enrollment and agree to use highly effective contraception during the study and for ≥120 days after the last dose...
- Non-sterilized men must agree to use highly effective contraception during the study and for ≥120 days after the last dose of zanidatamab, tislelizumab, or chemotherapy (whichever occurs later).
- Pregnant or breastfeeding women.
- Uncontrolled infection requiring systemic therapy.
- Diagnosis of another malignancy within the past 5 years.
- Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).
- Prior radiotherapy to the bladder for bladder cancer.
- Active autoimmune disease requiring systemic treatment that, in the investigator's judgment, would affect study therapy.
- Any of the following cardiovascular criteria:
- Cardiac chest pain within ≤28 days before first study dose, defined as moderate pain that limits activities of daily living.
- Symptomatic pulmonary embolism within ≤28 days before first study dose.
- Any acute myocardial infarction within ≤6 months before first study dose.
- Any history of heart failure of New York Heart Association (NYHA) Class III or IV within ≤6 months before first study dose.
- Any ventricular arrhythmia of severity ≥ Grade 2 within ≤6 months before first study dose.
- Any cerebrovascular accident within ≤6 months before first study dose.
- Corrected QT interval (QTc by Fridericia): ≥470 msec for women or ≥450 msec for men. i. Note: If the initial ECG shows QTc \>450 msec (men) or \>470 msec (women), a follow-up ECG should be performed to confirm. h) Left...
- History of acute myocardial infarction or ischemic stroke within 6 months.
- Human immunodeficiency virus (HIV) infection (i.e., positive antibodies to HIV-1/2), active syphilis infection, or active tuberculosis infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary disease, including pulmonary fibrosis or acute lung disease.
- Known hypersensitivity to any study drug.
- Concurrent participation in another clinical study, unless observational (non-treatment) or in the follow-up phase of an treatment study.
- Any other condition deemed by the investigator to render the patient ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Putian, Fujian, China
- Quanzhou, Fujian, China
- Sanming, Fujian, China
- Xiamen, Fujian, China
- Zhangzhou, Fujian, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Putian, Fujian, China; Quanzhou, Fujian, China; Sanming, Fujian, China; Xiamen, Fujian, China; Zhangzhou, Fujian, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.