Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+/2+/3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks) in combination with BCG therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years;
Histologically confirmed non-muscle-invasive urothelial cell carcinoma (UCC) of the bladder; A.Histopathology: any variant of UCC, The presence of any lymphovascular infiltration (LVI) was considered evidence of high risk. B. Confined to the mucosal (Ta, Tis) and lamina propria layers (T1) of the bladder. In addition, subjects had all visible tumors removed as completely as possible prior to the first dose of study drug and documented at baseline cystoscopy. C. CIS(Carcinoma in situ) does not require complete resection, but coexisting papillary carcinoma must be removed as completely as possible prior to enrollment and documented at baseline cystoscopy. Negative urine cytology results against malignant tumor cells are not required.
Presence of HER2 expression (IHC 1+/2+/3+) by IHC in our pathology department;
VHR(Very high risk) NMIBC, defined as having at least 1 of the following: Multiple and/or large (greater than [>] 3 centimeters [cm]) T1, (HG/G3) tumors; T1, (HG/G3) tumor with concurrent CIS; T1, G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial carcinoma;
Disqualifiers
Evidence of locally advanced, metastatic, muscle-invasive, and/or extravesical bladder cancer;
Upper urinary tract urothelial carcinoma(UTIC), except 2 years without recurrence after previous radical UTUC;
Histopathologic examination reveals any small cell component of the bladder, simple adenocarcinoma, simple squamous cell carcinoma or simple squamous CIS;
Previously received other anti-HER-2 therapy;
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab vedotin
Drug2.0 mg/kg, administered intravenously every three weeks
Bacillus Calmette Guerin Vaccine
DrugInduction therapy, i.e., intravesical therapy once a week for 6 weeks. maintenance therapy, i.e., one course of maintenance therapy at three, six and twelve months after surgery, each course once a week for 3 weeks.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RC48+BCGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants With CR as Assessed by the Investigator according to Cystoscopy and Urine Cytology at Month 3
CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology.
Time frame
up to 3 months2
Event-Free Survival (EFS) rate, as Assessed according to Cystoscopy and Urine Cytology
Percentage of Participants With Event-Free Survival (EFS), as assessed according to Cystoscopy and Urine Cytology ( patients who are alive and free of persistent/recurrent high-grade NMIBC.)
Time frame
up to 6 monthsSecondary outcomes
1
Percentage of Participants With CR as Assessed by the Investigator according to Cystoscopy and Urine Cytology at Month 6, 12
CR at the 6, 12-month disease assessment, evaluated by both cystoscopy and cytology.
Time frame
up to 12 months from the date of randomization as assessed by the investigator according to cystoscopic assessment and urine cytology2
Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.
Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.
Time frame
From first occurence of a documented CR until the time of recurrence of NMIBC or death from any cause, whichever came first, assessed up to 24 months3
Percentage of Participants With Event-Free Survival (EFS), as Assessed according to Cystoscopy and Urine Cytology
EFS rate at 12, 24 months, defined as the proportion of patients who are alive and free of persistent/recurrent high-grade NMIBC.
Time frame
up to 24 months4
Progression-Free Survival (PFS), as Assessed according to Cystoscopy and Urine Cytology
PFS, defined as the time from the first study treatment to the first occurrence of progression to muscle-invasive disease based on cystoscopy and urine cytology or death from any cause.
Time frame
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov