This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Disitamab Vedotin 120mg will be administered on Day 1 of each cycle for 4 treatment cycles;Tislelizumab 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
Disitamab Vedotin
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplete Response (CR) Rate
Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)
Progress Free Survival(PFS)
Time frame: up to 3 years
Recurrence Free Survival(RFS)
Time frame: up to 3 years
Cystectomy-Free Survival (CFS)
defined from D1 of treatment until cystectomy
Time frame: up to 3 years
Duration of Response (DOR)
Time frame: up to 3 years
Event-Free Survival(EFS)
defined from D1 of treatment until the time of any events,included progressive disease,discontinue treatment for any cause or death
Time frame: up to 3 years
Number of adverse events and severity by grade (CTCAE)
Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).
Time frame: 12 weeks of treatment plus 30 days for toxicity followup
Her2 status
Time frame: up to 3 years
PD-1 expression status
Time frame: up to 3 years
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