Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05911295

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 30 Locations for this study

See Locations Near You

Alaska Oncology and Hematology
Anchorage Alaska, 99508, United States More Info
Steven Liu, MD
Contact
[email protected]
Steven Liu, MD
Principal Investigator
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Isaac Bowman
Contact
347-673-9487
[email protected]
Isaac Bowman
Principal Investigator
The Oncology Institute of Hope & Innovation - California
Cerritos California, 90703, United States More Info
Pamela Miel
Contact
562-693-4477
[email protected]
Pamela Miel
Principal Investigator
Compassionate Care Research Group
Fountain Valley California, 92708, United States More Info
Eric H Lee
Contact
714-698-0300
[email protected]
Eric H Lee
Principal Investigator
University of California Los Angeles Medical Center
Los Angeles California, 90095, United States More Info
Alexandra Drakaki
Contact
210-206-6766
[email protected]
Alexandra Drakaki
Principal Investigator
Pacific Cancer Care
Monterey California, 93940, United States More Info
Michael Zachary Koontz
Contact
831-375-4105
[email protected]
Michael Zachary Koontz
Principal Investigator
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco California, 94143, United States More Info
Vadim Koshkin
Contact
773-837-0783
[email protected]
Vadim Koshkin
Principal Investigator
Providence Medical Foundation
Santa Rosa California, 95403, United States More Info
Ian C Anderson
Contact
707-521-3814
[email protected]
Ian C Anderson
Principal Investigator
PIH Health Hospital Whittier
Whittier California, 90602, United States More Info
Lisa Wang, MD
Contact
562-789-5480
[email protected]
Lisa Wang, MD
Principal Investigator
Decatur Memorial Hospital - Illinois
Decatur Illinois, 62526, United States More Info
James L Wade III
Contact
217-876-6600
[email protected]
James L Wade III
Principal Investigator
Illinois Cancer Care
Peoria Illinois, 61615, United States More Info
Gary R MacVicar
Contact
309-243-3614
[email protected]
Gary R MacVicar
Principal Investigator
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City Iowa, 51101, United States More Info
Donald Wender
Contact
712-252-0088
[email protected]
Donald Wender
Principal Investigator
HealthPartners Institute
Saint Louis Park Minnesota, 55426, United States More Info
Yan Ji
Principal Investigator
Cancer Partners of Nebraska
Lincoln Nebraska, 68516, United States More Info
Haris Zahoor
Contact
402-327-7363
[email protected]
Haris Zahoor
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Benjamin Teply
Contact
402-559-5166
[email protected]
Benjamin Teply
Principal Investigator
North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital
Lake Success New York, 11042, United States More Info
Thomas P Bradley
Contact
516-734-7688
[email protected]
Thomas P Bradley
Principal Investigator
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Earle Burgess
Contact
908-442-2000
[email protected]
Earle Burgess
Principal Investigator
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Laurence Belkoff, MD
Contact
610-246-2493
[email protected]
Laurence Belkoff, MD
Principal Investigator
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
Shifeng S Mao
Contact
412-359-6147
[email protected]
Shifeng S Mao
Principal Investigator
West Cancer Center & Research Institute
Germantown Tennessee, 38138, United States More Info
Daniel A Vaena
Contact
901-683-0055
[email protected]
Daniel A Vaena
Principal Investigator
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States More Info
David Dewayne Chism
Contact
865-541-1678
[email protected]
David Dewayne Chism
Principal Investigator
University of Tennessee
Knoxville Tennessee, 37920, United States More Info
Saikrishna Gadde
Contact
504-236-8408
[email protected]
Saikrishna Gadde
Principal Investigator
US Oncology Central Regulatory
The Woodlands Texas, 77380, United States
Providence Regional Medical Center Everett
Everett Washington, 98201, United States More Info
Meng Zhao, MD
Contact
425-297-5577
[email protected]
Meng Zhao, MD
Principal Investigator
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Evan Yu
Principal Investigator
Macquarie University Hospital
Brisbane Other, 2109, Australia More Info
Alison Zhang
Principal Investigator
Peninsula and South East Oncology
Frankston Other, 3199, Australia More Info
Sanjeev Sewak
Principal Investigator
Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)
Oshawa Ontario, L1G 2, Canada More Info
Pawel Zalewski
Principal Investigator
University Health Network, Princess Margaret Hospital
Toronto Other, M5G 2, Canada More Info
Srikala Sridhar
Principal Investigator
National Cancer Centre Singapore
Singapore Other, 16961, Singapore More Info
Ravindran Kanesvaran
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT05911295

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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