Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
a study on Transitional Cell Carcinoma HER2 Carcinoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Alhambra, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Alexandra Drakaki, MD
Description
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)
Keywords
Urothelial Carcinoma, Urothelial Cancer, LA/mUC, Bladder Cancer, HER2 Overexpression, HER2 Amplification, HER2, Seattle Genetics, Carcinoma, Transitional Cell Carcinoma, Carboplatin, Gemcitabine, Pembrolizumab, Disitamab vedotin, cisplatin
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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
- UCLA Hematology/Oncology - Alhambra
accepting new patients
Alhambra California 91801 United States - UCLA Burbank Cardiology
accepting new patients
Burbank California 91505 United States - UCLA Hematology/Oncology - Burbank
accepting new patients
Burbank California 91505 United States - UCLA Calabasas Specialty Care
accepting new patients
Calabasas California 91302 United States - UCLA Encino Specialty Care (Radiology)
accepting new patients
Encino California 91436 United States - UCLA Hematology/Oncology - Encino
accepting new patients
Encino California 91436 United States - UCLA Downtown Los Angeles Primary & Specialty Care
accepting new patients
Los Angeles California 90017 United States - Administrative Address: UCLA Hematology/Oncology
accepting new patients
Los Angeles California 90095 United States - UCLA Cardiovascular Center
accepting new patients
Los Angeles California 90095 United States - UCLA Hematology & Oncology Clinic
accepting new patients
Los Angeles California 90095 United States - UCLA Hematology / Oncology
accepting new patients
Los Angeles California 90095 United States - UCLA Westwood Specialty Care
accepting new patients
Los Angeles California 90095 United States - UCLA Porter Ranch Primary & Specialty Care
accepting new patients
Porter Ranch California 91326 United States - UCLA Hematology/Oncology - Santa Monica
accepting new patients
Santa Monica California 90404 United States - UCLA Simi Valley Alamo Specialty Care
accepting new patients
Simi Valley California 93065 United States - UCLA Thousand Oaks Primary & Specialty Care
accepting new patients
Thousand Oaks California 91360 United States - UCLA Hematology/Oncology - Torrance
accepting new patients
Torrance California 90505 United States - UCLA Torrance Lomita Specialty Care
accepting new patients
Torrance California 90505 United States - UCLA Santa Clarita Primary & Specialty Care
accepting new patients
Valencia California 91355 United States - UCLA Ventura Cardiology
accepting new patients
Ventura California 93003 United States - UCLA Hematology/Oncology - Westlake
accepting new patients
Westlake Village California 91361 United States
Lead Scientist at UCLA
- Alexandra Drakaki, MD
HS Associate Clinical Professor, Medicine. Authored (or co-authored) 118 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Links
- Sign up for this study
- ID
- NCT05911295
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 400 study participants
- Last Updated
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