Last updated 38 days ago
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
700 patients around the world
Available in Peru, Argentina
Seagen Inc.
5Research sites
700Patients around the world
This study is for people with
Urothelial cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.Measurable disease by investigator assessment per RECIST v1.1.Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.Eligible to receive cisplatin- or carboplatin-containing chemotherapy.Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.HER2 expression of 1+ or greater on immunohistochemistry (IHC).Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.
- Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.History of or active autoimmune disease that has required systemic treatment in the past 2 years.Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).Prior solid organ or bone marrow transplantation.Pleural effusion or ascites with symptoms or requiring symptomatic treatment.Estimated life expectancy <12 week.Prior treatment with an MMAE agent or anti-HER2 therapy.
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Centro Oncológico Korben
Recruiting
Oncología Salta
Recruiting
Investigaciones Clínicas Moleculares - ICM
Recruiting
Hospital Maria Auxiliadora - Lima
Recruiting
SponsorSeagen Inc.
Conditions
Urothelial cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05911295
