RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-09-22
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05911295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
  2. * Measurable disease by investigator assessment per RECIST v1.1.
  3. * 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.
  4. * Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
  5. * 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.
  6. * HER2 expression of 1+ or greater on immunohistochemistry (IHC).
  7. * Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.
  1. * Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
  2. * History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
  3. * Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.
  4. * CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
  5. * Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
  6. * History of or active autoimmune disease that has required systemic treatment in the past 2 years.
  7. * 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).
  8. * Prior solid organ or bone marrow transplantation.
  9. * Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
  10. * Estimated life expectancy \<12 week
  11. * Prior treatment with an MMAE agent or anti-HER2 therapy

Contacts and Locations

Study Contact

Seagen Trial Information Support
CONTACT
866-333-7436
clinicaltrials@seagen.com

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Seagen Inc.

Study Locations (Sites)

Alaska Oncology and Hematology
Anchorage, Alaska, 99508
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
The Oncology Institute of Hope & Innovation - California
Cerritos, California, 90703
United States
Los Angeles Cancer Network / Compassionate Care Research Group
Fountain Valley, California, 92708
United States
University of California Los Angeles Medical Center
Los Angeles, California, 90095
United States
Pacific Cancer Care
Monterey, California, 93940
United States
Kaiser Permanente Southern California
Riverside, California, 92505
United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94143
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
PIH Health Hospital Whittier
Whittier, California, 90602
United States
Decatur Memorial Hospital - Illinois
Decatur, Illinois, 62526
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, 51101
United States
Greater Baltimore Medical Center (GBMC) - Sandra & Malcolm Berman Cancer Institute
Baltimore, Maryland, 21204
United States
University of Minnesota
Burnsville, Minnesota, 55337
United States
HealthPartners Institute
Saint Louis Park, Minnesota, 55426
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6840
United States
OptumCare Cancer Center
Las Vegas, Nevada, 89102
United States
North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital
Lake Success, New York, 11042
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
ECU Health Medical Center
Greenville, North Carolina, 27834
United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
United States
University of Tennessee
Knoxville, Tennessee, 37920
United States
US Oncology Central Regulatory
The Woodlands, Texas, 77380
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Providence Regional Medical Center Everett
Everett, Washington, 98201
United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109
United States
Medical College of Wisconsin (Milwaukee)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Seagen Inc.

  • Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • Urothelial Cancer
  • LA/mUC
  • Bladder Cancer
  • HER2 Overexpression
  • HER2 Amplification
  • HER2
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Urothelial Carcinoma