A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
← catalyst calendarNCT04879329 · readout in 113 d
Sponsored by Seagen, a wholly owned subsidiary of Pfizer (industry) · PFE — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
372estimated
Sites
221
Countries
Argentina, Australia, Belgium +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-05-03 | actual | When the study began enrolling |
| Primary completion | 2026-12-11 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-04-14 | estimated | The whole study's end, after follow-up |
| First posted | 2021-05-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Urothelial Carcinoma
Interventions
- Drug: disitamab vedotin — also filed as RC48-ADC
- Drug: pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFConfirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G)
measured Duration of treatment; approximately 2 years
Incidence of adverse events (AEs) (Cohorts D and E)
measured Approximately 2 years
Incidence of dose alterations (Cohorts D and E)
measured Approximately 2 years
Incidence of laboratory abnormalities (Cohorts D and E)
measured Approximately 2 years
Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)
measured Approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
measured Approximately 2 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
measured Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Maximum concentration (Cmax) (Cohorts D and E)
measured Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E)
measured Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Trough concentration (Ctrough) (Cohorts D and E)
measured Through 30-37 days following the last dose of DV; up to approximately 2 years
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