Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
NCT05911295Phase 3Active, not recruiting
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer (Industry)
- Enrollment
- 412 (actual)
- Start date
- 22 Sep 2023
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 30 Apr 2029
- Last update posted
- 22 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- disitamab vedotin Drug
- pembrolizumab Drug
- gemcitabine Drug
- cisplatin Drug
- carboplatin Drug
Conditions and primary outcome
- Urothelial Carcinoma
Primary outcome
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) (Approximately 3 years); Overall survival (OS) (Approximately 5 years)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT05911295.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05911295 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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