Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

NCT05911295 · readout in 162 d

Sponsored by Seagen, a wholly owned subsidiary of Pfizer (industry) · PFE — their whole pipeline →. With RemeGen Co., Ltd., Merck Sharp & Dohme LLC.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

412actual

Sites

268

Countries

Argentina, Australia, Belgium +21

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

2023-09-22

actual

When the study began enrolling

Primary completion

2027-01-29

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-04-30

estimated

The whole study's end, after follow-up

First posted

2023-06-22

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, RC48-ADC
Drug: pembrolizumab — also filed as KEYTRUDA®
Drug: gemcitabine — also filed as Gemzar
Drug: cisplatin
Drug: carboplatin

Primary outcomes

what the primary-completion date above is the date OF

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

measured Approximately 3 years

Overall survival (OS)

measured Approximately 5 years

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