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Clinical Trials List

Protocol NumberC5731001/SGNDV-001

NCT Number(ClinicalTrials.gov Identfier)NCT05911295

Active

2023-12-01 - 2029-04-30

Phase III

Recruiting9

ICD-10C79.10

Secondary malignant neoplasm of unspecified urinary organs

ICD-10C79.11

Secondary malignant neoplasm of bladder

ICD-10C79.19

Secondary malignant neoplasm of other urinary organs

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9198.1

Secondary malignant neoplasm of other urinary organs

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)

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/23

Investigators and Locations

Principal Investigator Jian-Ri Li 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 呂長賢無

Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹朝榮無

Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Chieh Tsai 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 康智雄無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文冠無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hsiang Chang 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Jeng Wu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Urothelial Carcinoma

Objectives

Primary: • Compare the efficacy of disitamab vedotin plus pembrolizumab as a first-line treatment versus chemotherapy in participants with HER2-positive advanced UC. Secondary: • Compare the objective response rate (ORR) of disitamab vedotin plus pembrolizumab versus chemotherapy. • Compare the duration of response (DOR) of disitamab vedotin plus pembrolizumab versus chemotherapy. • Compare the disease control rate (DCR) of disitamab vedotin plus pembrolizumab versus chemotherapy. • Compare the progression-free survival (PFS) of disitamab vedotin plus pembrolizumab versus chemotherapy, as assessed by the trial administrator. • Assess the safety profile of each treatment cycle. • Compare the impact of disitamab vedotin plus pembrolizumab versus chemotherapy on quality of life (QoL) and symptoms, including pain, from the participant's perspective.

Test Drug

Dry powder injection
Injection

Active Ingredient

Disitamab Vedotin
Pembrolizumab

Dosage Form

240
270

Dosage

45mg
100mg

Endpoints

• Progression-free survival (PFS) assessed by a blinded independent central review committee (BICR) according to the Responsive Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1

• Overall survival (OS)

Inclution 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

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

The Estimated Number of Participants

Taiwan

22 participants
Global

400 participants