A Phase 2 interventional study of Disitamab Vedotin Tislelizumab and Disitamab Vedotin in Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Tianjin Medical University Second Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 176 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:
a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);
Organ function level must meet or under the support treatment meet the following requirements:
Exclusion Criteria:
Uncontrolled concurrent diseases, including but not limited to:
Disitamab Vedotin 120mg IV on day 1 in combination with Tislelizumab 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
Drug: Disitamab Vedotin Tislelizumab
Disitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
Drug: Disitamab Vedotin
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.
Also known as: KEYNOTE-057
Disitamab Vedotin
Complete 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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Tianjin Medical University Second Hospital