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NCT05911295

PHASE3

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2023-09-22

Completion Date

2029-04-30

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Urothelial Carcinoma

Interventions

DRUG

disitamab vedotin

Given into the vein (IV; intravenous) every 2 weeks

DRUG

pembrolizumab

400mg given by IV every 6 weeks

DRUG

gemcitabine

1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle

DRUG

cisplatin

70 mg\^2 given by IV on day 1 of every 3-week cycle

DRUG

carboplatin

Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (268)

Banner Gateway Medical Center

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

UCLA Hematology/Oncology - Alhambra

Alhambra, California, United States

Foothill Cardioology

Arcadia, California, United States

Beverly Hills Multi-Specialties Practice

Beverly Hills, California, United States

Providence Saint Joseph Medical Center

Burbank, California, United States

UCLA Burbank Cardiology

Burbank, California, United States

UCLA Hematology/Oncology - Burbank

Burbank, California, United States

UCLA Calabasas Specialty Care

Calabasas, California, United States

UCLA Encino Specialty Care (Radiology)

Encino, California, United States

UCLA Hematology/Oncology - Encino

Encino, California, United States

Helios Clinical Research

Fountain Valley, California, United States

Helios Clinical Research

Glendale, California, United States

Foothill Cardiology Glendora

Glendora, California, United States

Helios Clinical Research

Long Beach, California, United States

UCLA Downtown Los Angeles Primary & Specialty Care

Los Angeles, California, United States

UCLA Cardiovascular Center

Los Angeles, California, United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, United States

UCLA Hematology & Oncology Clinic

Los Angeles, California, United States

UCLA Hematology / Oncology

Los Angeles, California, United States

UCLA Westwood Specialty Care

Los Angeles, California, United States

UCLA Montecito Primary & Specialty Care

Montecito, California, United States

Pacific Cancer Care

Monterey, California, United States

Newport Diagnostics

Newport Beach, California, United States

Foothill Cardiology Pasadena

Pasadena, California, United States

Southern California Heart Specialists

Pasadena, California, United States

UCLA Porter Ranch Primary & Specialty Care

Porter Ranch, California, United States

UCSF Center at China Basin Imaging