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

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)

INTRODUCTION

  • Org Study ID: SGNDV-001
  • Secondary ID: N/A
  • NCT ID: NCT05911295
  • Sponsor: Seagen Inc.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    September 22, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Kevin Sokolowski, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Seagen Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: Alaska Oncology and Hematology
Anchorage, Alaska 99508
United States
Status: Recruiting Contact: Contact
Steven Liu, MD
muggawugga@yahoo.com

Principal Investigator
Steven Liu, MD

Facility: Compassionate Care Research Group
Fountain Valley, California 92708
United States
Status: Recruiting Contact: Contact
Eric H Lee
714-698-0300
ericlee@compcancercare.com

Principal Investigator
Eric H Lee

Facility: Pacific Cancer Care
Monterey, California 93940
United States
Status: Recruiting Contact: Contact
Michael Zachary Koontz
831-375-4105
koontz@pacificcancercare.com

Principal Investigator
Michael Zachary Koontz

Facility: Providence Medical Foundation
Santa Rosa, California 95403
United States
Status: Recruiting Contact: Contact
Ian C Anderson
707-521-3814
Ian.Anderson@Providence.org

Principal Investigator
Ian C Anderson

Facility: PIH Health Hospital Whittier
Whittier, California 90602
United States
Status: Recruiting Contact: Contact
Lisa Wang, MD
562-789-5480
Lisa.Wang@pihhealth.org

Principal Investigator
Lisa Wang, MD

Facility: The Oncology Institute of Hope & Innovation - California
Whittier, California 90602
United States
Status: Recruiting Contact: Contact
Pamela Miel
562-693-4477
pmiel@airesearch.us

Principal Investigator
Pamela Miel

Facility: Decatur Memorial Hospital - Illinois
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
James L Wade III
217-876-6600
jlwade3@sbcglobal.net

Principal Investigator
James L Wade III

Facility: Illinois Cancer Care
Peoria, Illinois 61615
United States
Status: Recruiting Contact: Contact
Gary R MacVicar
309-243-3614
gmacvicar@illinoiscancercare.com

Principal Investigator
Gary R MacVicar

Facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa 51101
United States
Status: Recruiting Contact: Contact
Donald Wender
712-252-0088
wenderd@jencc.com

Principal Investigator
Donald Wender

Facility: HealthPartners Institute
Saint Louis Park, Minnesota 55426
United States
Status: Recruiting Contact: Contact
Yan Ji
608-698-5962
yan.x.ji@healthpartners.com

Principal Investigator
Yan Ji

Facility: Cancer Partners of Nebraska
Lincoln, Nebraska 68510
United States
Status: Recruiting Contact: Contact
Haris Zahoor
402-327-7363
zahoorresearch@cancerpartners.com

Principal Investigator
Haris Zahoor

Facility: University of Nebraska Medical Center
Omaha, Nebraska 68198-6840
United States
Status: Recruiting Contact: Contact
Benjamin Teply
402-559-5166
ben.teply@unmc.edu

Principal Investigator
Benjamin Teply

Facility: North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
Thomas P Bradley
516-734-7688
tbradley@northwell.edu

Principal Investigator
Thomas P Bradley

Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Earle Burgess
908-442-2000
Earle.Burgess@atriumhealth.org

Principal Investigator
Earle Burgess

Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Laurence Belkoff, MD
610-246-2493
lbelkoff@midlanticurology.com

Principal Investigator
Laurence Belkoff, MD

Facility: Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Status: Recruiting Contact: Contact
Shifeng S Mao
412-359-6147
shifeng.mao@ahn.org

Principal Investigator
Shifeng S Mao

Facility: West Cancer Center & Research Institute
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: Contact
Daniel A Vaena
901-683-0055
DVaena@WESTCLINIC.com

Principal Investigator
Daniel A Vaena

Facility: Thompson Cancer Survival Center
Knoxville, Tennessee 37916
United States
Status: Recruiting Contact: Contact
David Dewayne Chism
865-541-1678
dchism@CovHlth.com

Principal Investigator
David Dewayne Chism

Facility: University of Tennessee
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: Contact
Saikrishna Gadde
504-236-8408
sgadde@utmck.edu

Principal Investigator
Saikrishna Gadde

Facility: Providence Regional Medical Center Everett
Everett, Washington 98201
United States
Status: Recruiting Contact: Contact
Meng Zhao, MD
425-297-5577
mzhao@everettclinic.com

Principal Investigator
Meng Zhao, MD

Facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Evan Yu
206-288-7222
evanyu@uw.edu

Principal Investigator
Evan Yu