RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).
Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue.
The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy.
Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years old
Histologically confirmed recurrent, non-muscle invasive bladder cancer;
Histopathology: Patients with any variant urothelial cell carcinoma (UCC) (i.e., squamous and/or glandular epithelial differentiation UCC, UCC with micropapillary changes, nest variant UCC, plasmacytoid UCC, neuroendocrine UCC, and sarcomatoid UCC) were enrolled. The presence of any lymphatic infiltration (LVI) is considered evidence of high risk.
Papillary carcinoma must be a high-risk disease defined as a high grade Ta/T1 lesion. In addition, subjects must have all visible tumors completely removed prior to initial administration of the study drug, as documented at baseline cystoscopy. Cytological results for high-grade urothelial carcinoma must be negative prior to initial administration of the investigational drug.
Disqualifiers
Confirmed by histology of muscular layer infiltration (T2 or higher level) bladder urothelial carcinoma.
Histopathological examination revealed any bladder small cell composition, pure, pure squamous cell carcinoma or simple squamous adenocarcinoma CIS;
Received other PD - 1 / PD - L1 inhibitor and/or HER2 inhibitor;
Active malignancies other than the disease being treated (i.e., disease progression within the last 24 months or requiring a change in treatment). Only the following special circumstances are allowed: i. Skin cancer that has been treated and completely cured within the last 24 months; ii. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; iii. A history of local breast cancer and receiving antihormonal drugs or a history of local prostate cancer (N0M0) and receiving androgen blocking therapy.
Trial design
Design model
Single group
Treatments tested in this trial
RC48
DrugRC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.
Tislelizumab
DrugTislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RC48+TislelizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
2-yr Bladder-intact Disease-free Survival (BI-DFS)
Defined by time from enrollment to the occurrence of one of the following events: first MIBC or regional lymph node recurrence, distant metastasis, or death
Time frame
Up to 24 monthsSecondary outcomes
1
Time to Progression (TTP)
Defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause.
Time frame
Up to 24 months2
Time to Deterioration (TTD)
Defined by time from day of first treatment to first deterioration
Time frame
Up to 24 months3
Cystectomy Free Survival
Defined by time from day of first treatment to radical cystectomy
Time frame
Up to 24 months4
Disease-Specific Survival (DSS)
Defined by time from day of first treatment to invasive bladder cancer
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov