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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: Medical Monitor

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: Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Isaac Bowman
347-673-9487
isaac.bowman@bannerhealth.com

Principal Investigator
Isaac Bowman

Facility: The Oncology Institute of Hope & Innovation - California
Cerritos, California 90703
United States
Status: Recruiting Contact: Contact
Pamela Miel
562-693-4477
miel.clinicaltrials@theoncologyinstitute.com

Principal Investigator
Pamela Miel

Facility: University of California Los Angeles Medical Center
Los Angeles, California 90095
United States
Status: Recruiting Contact: Contact
Alexandra Drakaki
210-206-6766
adrakaki@mednet.ucla.edu

Principal Investigator
Alexandra Drakaki

Facility: University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California 94143
United States
Status: Recruiting Contact: Contact
Vadim Koshkin
773-837-0783
vadim.koshkin@ucsf.edu

Principal Investigator
Vadim Koshkin

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: Greater Baltimore Medical Center (GBMC) - Sandra & Malcolm Berman Cancer Institute
Baltimore, Maryland 21204
United States
Status: Recruiting Contact: Contact
Paul Celano
443-849-3051
pcelano@gbmc.org

Principal Investigator
Paul Celano

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: 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: OptumCare Cancer Center
Las Vegas, Nevada 89102
United States
Status: Recruiting Contact: Contact
Russell P Gollard, MD
Russell.gollard1@optum.com

Principal Investigator
Russell P Gollard, MD

Facility: Mount Sinai Medical Center
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Matthew Galsky
212-659-5452
matthew.galsky@mssm.edu

Principal Investigator
Matthew Galsky

Facility: ECU Health Medical Center
Greenville, North Carolina 27834
United States
Status: Recruiting Contact: Contact
Musharraf Navaid
252-847-4100
Musharraf.Navaid@Vidanthealth.com

Principal Investigator
Musharraf Navaid

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: 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