NCT05911295

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

Name: Clinical Trial NCT05911295
Creator: Seagen Inc.
Keywords: Urothelial Carcinoma, disitamab vedotin, Phase 3, drug, clinical trial, United States of America

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

Seagen Inc.·Phase 3·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Urothelial Carcinoma
Drug/Device/Intervention: disitamab vedotin
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Seagen Inc.
Location: Monterey,Decatur,Everett, United States of America

Timeline & enrollment

Phase: Phase 3
Start date: Aug 31, 2023
End date: Apr 30, 2029
Enrollment: 700 participants

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),Overall survival (OS)

Summary

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease.  Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced).  In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.

ICD-10 classifications

Carcinoma in situ: Other and unspecified urinary organsMalignant neoplasm of ureterMalignant neoplasms of urinary tractMalignant neoplasm: Overlapping lesion of urinary organsMalignant neoplasm: Urethra

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05911295
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05911295 through Pure Global AI's free database. This Phase 3 trial is sponsored by Seagen Inc. and is currently Recruiting. The study focuses on Urothelial Carcinoma. Target enrollment is 700 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.