Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Jun 9, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatment options for patients with urothelial cancer, which can affect the bladder, kidneys, or urinary tubes. The researchers want to find out if a combination of two drugs, disitamab vedotin and pembrolizumab, works better than standard chemotherapy that includes platinum-based drugs. The trial is open to individuals whose cancer has either spread in the body (metastatic) or is locally advanced and cannot be surgically removed. To participate, patients must have a specific type of urothelial cancer that shows a certain level of HER2 expression and must not have received any prior treatment for their cancer, except under certain conditions.
Participants in the study will be randomly assigned to one of two groups. One group will receive the study drugs every two weeks and every six weeks, while the other group will receive standard chemotherapy once a week for two weeks and then every three weeks. Throughout the trial, participants will be monitored for how well the treatments are working and for any side effects. This study is important as it may help improve treatment options for patients with urothelial cancer. If you’re considering participation, you should discuss with your doctor to see if you meet the eligibility criteria and to understand what being part of the trial involves.
Gender
ALL
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
About Seagen, A Wholly Owned Subsidiary Of Pfizer
Seagen, a wholly owned subsidiary of Pfizer, is a leading biotechnology company dedicated to developing innovative cancer therapies. With a strong focus on targeted therapies and antibody-drug conjugates, Seagen leverages its advanced scientific expertise and robust research capabilities to address the unmet needs of patients with various forms of cancer. The company's commitment to precision medicine and collaboration with healthcare professionals underpins its mission to improve treatment outcomes and enhance the quality of life for cancer patients worldwide. Through rigorous clinical trials and a patient-centric approach, Seagen aims to bring transformative therapies to market, advancing the field of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Lisboa, , Portugal
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Badalona, Barcelona, Spain
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Uppsala, Uppland, Sweden
Jonkoping, , Sweden
Taichung, , Taiwan
Taichung, , Taiwan
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Viedma, , Argentina
Viedma, , Argentina
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Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported