Not yet recruiting NCT05996952
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RC48-ADC.
- Who it may be relevant to
- Registry conditions: Non-muscle Invasive Bladder Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer
Overview
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Detailed description
This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Interventions
- Drug RC48-ADC
Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
Primary outcome measures
- 12-month recurence-free survival rate [Time frame: From treatment initiation to 12 month]
- 3-month pathological complete response rate [Time frame: From treatment initiation to 3 month]
- Adverse events [Time frame: From patient screening to 30 days after end of cycle 6]
Secondary outcome measures (6)
- 6-month recurence-free survival rate [Time frame: From treatment initiation to 6 month]
- Duration of response [Time frame: From time of complete response to up to 60 months]
- Recurrence-free survival [Time frame: From time of first dose of RC48-ADC adjuvant treatment to up to 60 months]
- Progression-free survival [Time frame: From time of first dose of RC48-ADC treatment to up to 60 months]
- Overall survival [Time frame: From time of first dose of RC48-ADC treatment to up to 60 months]
- Quality of life assessed by EQ-5D scale [Time frame: After every cycle of treatment and 30 days after end of cycle 6]
Eligibility criteria
Inclusion criteria
- Be willing and able to provide written informed consent/assent for the trial.
- Life expectancy ≥12 weeks.
- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
- Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
Exclusion criteria
- Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
- Allergic to study therapy.
- Has a known additional malignancy that has had progression or has required active treatment in the last five years.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
- Has had an allogeneic tissue/solid organ transplant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital — Chengdu
Identifiers
NCT: NCT05996952 · 2023(24)