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Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 - Trial NCT05911295

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.

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NCT05911295
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05911295
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Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
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)

Study Focus

Urothelial Carcinoma

disitamab vedotin

Interventional

drug

Sponsor & Location

Seagen Inc.

Monterey,Decatur,Everett, United States of America

Timeline & Enrollment

Phase 3

Aug 31, 2023

Apr 30, 2029

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 organs
Malignant neoplasm of ureter
Malignant neoplasms of urinary tract
Malignant neoplasm: Overlapping lesion of urinary organs
Malignant neoplasm: Urethra

Data Source

ClinicalTrials.gov

NCT05911295

Non-Device Trial