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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05911295
Registration number
NCT05911295
Ethics application status
Date submitted
9/06/2023
Date registered
22/06/2023
Date last updated
11/07/2025
Titles & IDs
Public title
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
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Scientific 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)
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Secondary ID [1]
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C5731001
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Secondary ID [2]
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SGNDV-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
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0
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0
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Kidney
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Cancer
0
0
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0
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - disitamab vedotin
Treatment: Drugs - pembrolizumab
Treatment: Drugs - gemcitabine
Treatment: Drugs - cisplatin
Treatment: Drugs - carboplatin
Experimental: Disitamab vedotin arm - disitamab vedotin + pembrolizumab
Active comparator: Standard of care arm - gemcitabine + cisplatin OR carboplatin
Treatment: Drugs: disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks
Treatment: Drugs: pembrolizumab
400mg given by IV every 6 weeks
Treatment: Drugs: gemcitabine
1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle
Treatment: Drugs: cisplatin
70 mg\^2 given by IV on day 1 of every 3-week cycle
Treatment: Drugs: carboplatin
Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
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Assessment method [1]
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The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
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Timepoint [1]
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Approximately 3 years
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Primary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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The time from date of randomization to date of death due to any cause.
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Timepoint [2]
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Approximately 5 years
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Secondary outcome [1]
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Objective response rate (ORR) per RECIST v1.1 by BICR
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Assessment method [1]
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0
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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0
ORR per RECIST v1.1 by investigator assessment
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Assessment method [2]
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0
The proportion of participants with confirmed CR or PR according to RECIST v1.1.
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [3]
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Duration of Response (DOR) per RECIST v1.1 by BICR
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Assessment method [3]
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The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.
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Timepoint [3]
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Approximately 3 years
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Secondary outcome [4]
0
0
DOR per RECIST v1.1 by investigator assessment
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Assessment method [4]
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0
The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.
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Timepoint [4]
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0
Approximately 3 years
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Secondary outcome [5]
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0
Control Rate (DCR) per RECIST v1.1 by BICR
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Assessment method [5]
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0
The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.
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Timepoint [5]
0
0
Approximately 3 years
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Secondary outcome [6]
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0
DCR per RECIST v1.1 by investigator assessment
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Assessment method [6]
0
0
The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.
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Timepoint [6]
0
0
Approximately 3 years
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Secondary outcome [7]
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0
PFS per RECIST v1.1 by investigator assessment
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Assessment method [7]
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0
The time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause.
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Timepoint [7]
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Approximately 3 years
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Secondary outcome [8]
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Number of participants with adverse events (AEs)
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Assessment method [8]
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0
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [8]
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Through 30 days after the last study treatment; approximately 2 years
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Secondary outcome [9]
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Number of participants with laboratory abnormalities
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Assessment method [9]
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0
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Timepoint [9]
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Through 30 days after the last study treatment; approximately 2 years
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Secondary outcome [10]
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Treatment discontinuation rate due to AEs
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Assessment method [10]
0
0
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Timepoint [10]
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Approximately 2 years
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Secondary outcome [11]
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Number of electrocardiogram (ECG) abnormalities
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Assessment method [11]
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0
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Timepoint [11]
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Through 30 days after the last study treatment; approximately 2 years
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Secondary outcome [12]
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Change from baseline of left ventricular ejection fraction (LVEF)
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Assessment method [12]
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0
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Timepoint [12]
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Through 2 years after last study treatment; approximately 4 years
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Secondary outcome [13]
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Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score
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Assessment method [13]
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The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.
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Timepoint [13]
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Approximately 2 years
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Secondary outcome [14]
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Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score
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Assessment method [14]
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The time from the date of randomization to the date of first deterioration (change from baseline =10) in GHS/QoL score with no subsequent recovery. The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.
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Timepoint [14]
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Approximately 2 years
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Secondary outcome [15]
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Time to pain progression
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Assessment method [15]
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The time from the date of randomization to whichever of the following occurs earlier: * an increase in Numeric Rating Scale (NRS) for pain intensity of 2 points or more from baseline at 2 consecutive visits, * an increase in number of opioid or analgesic use from baseline, * or initiation of opioid or analgesic use. NRS for pain intensity asks participants to best describe their pain at its worst in the last 24 hours from 0 to 10. On the NRS, 0 means no pain and 10 means pain as bad as you can imagine.
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Timepoint [15]
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Approximately 2 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2029
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Saint Vincents Hospital Sydney - Human Research Ethics Committee - Darlinghurst
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Recruitment hospital [3]
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St Vincent's Clinic - Darlinghurst
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Macquarie University Hospital - Macquarie University
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Recruitment hospital [5]
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Macquarie University - North Ryde
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Prince of Wales Hospital - Randwick
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Recruitment hospital [7]
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North Shore Private Hospital - St Leonards
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Recruitment hospital [8]
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Mater Misericordiae - Mater Hospital Brisbane - Brisbane
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Recruitment hospital [9]
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Icon Cancer Centre Chermside - Herston
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Recruitment hospital [10]
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Mater Research - South Bribane
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Recruitment hospital [11]
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Peninsula & South Eastern Hematology and Oncology Group (PASO) - Frankston
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Recruitment hospital [12]
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South Eastern Sydney Local Health District - Caringbah
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Recruitment hospital [13]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [14]
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Peninsula And South East Oncology - Frankston
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Recruitment hospital [15]
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Cabrini. - Malvern
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Recruitment hospital [16]
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Mid North Coast Local Health District - NSW
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Recruitment hospital [17]
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [18]
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Mater Cancer Care Centre - South Brisbane
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Recruitment hospital [19]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2109 - Macquarie University
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Recruitment postcode(s) [4]
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2109 - North Ryde
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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4101 - Brisbane
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Recruitment postcode(s) [8]
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4029 - Herston
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Recruitment postcode(s) [9]
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4101 - South Bribane
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Recruitment postcode(s) [10]
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3199 - Frankston
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Recruitment postcode(s) [11]
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2229 - Caringbah
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Recruitment postcode(s) [12]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [13]
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3144 - Malvern
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Recruitment postcode(s) [14]
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NSW 2450 - NSW
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Recruitment postcode(s) [15]
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2444 - Port Macquarie
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Recruitment postcode(s) [16]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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California
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Maryland
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New York
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North Carolina
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Virginia
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Washington
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Argentina
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Israel
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Afula
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Israel
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Israel
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Hafia
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Israel
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Apulia
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Emilia-romagna
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Liguria
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Lombardy
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Milano
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Milan
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Italy
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Naples
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0
Italy
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State/province [77]
0
0
Piemonte
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Country [78]
0
0
Italy
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State/province [78]
0
0
Pordenone
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Country [79]
0
0
Italy
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State/province [79]
0
0
Ravenna
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Country [80]
0
0
Italy
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State/province [80]
0
0
RA
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Country [81]
0
0
Italy
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State/province [81]
0
0
Tuscany
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Country [82]
0
0
Italy
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State/province [82]
0
0
Umbria
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Country [83]
0
0
Italy
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State/province [83]
0
0
Asti
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Country [84]
0
0
Italy
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State/province [84]
0
0
Cremona
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Country [85]
0
0
Italy
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State/province [85]
0
0
Firenze
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Country [86]
0
0
Italy
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State/province [86]
0
0
Genova
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Country [87]
0
0
Italy
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State/province [87]
0
0
Napoli
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Country [88]
0
0
Italy
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State/province [88]
0
0
Padova
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Country [89]
0
0
Italy
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State/province [89]
0
0
Pisa
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Country [90]
0
0
Italy
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State/province [90]
0
0
Roma
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Country [91]
0
0
Italy
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State/province [91]
0
0
Verona
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Country [92]
0
0
Japan
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State/province [92]
0
0
Fukuoka
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Country [93]
0
0
Japan
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State/province [93]
0
0
Gunma
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Country [94]
0
0
Japan
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State/province [94]
0
0
Hyogo
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Country [95]
0
0
Japan
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State/province [95]
0
0
Kagawa
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Country [96]
0
0
Japan
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State/province [96]
0
0
Kanagawa
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Country [97]
0
0
Japan
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State/province [97]
0
0
Nara
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Country [98]
0
0
Japan
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State/province [98]
0
0
Osaka
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Country [99]
0
0
Japan
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State/province [99]
0
0
Tokushima
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Country [100]
0
0
Japan
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State/province [100]
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0
Tokyo
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Country [101]
0
0
Japan
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State/province [101]
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0
Wakayama
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Country [102]
0
0
Japan
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State/province [102]
0
0
Yamaguchi
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Country [103]
0
0
Japan
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State/province [103]
0
0
Chiba
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Country [104]
0
0
Japan
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State/province [104]
0
0
Kumamoto
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Country [105]
0
0
Japan
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State/province [105]
0
0
Yamagata
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Country [106]
0
0
Korea, Republic of
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State/province [106]
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0
Gyeonggi-do
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Country [107]
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0
Korea, Republic of
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State/province [107]
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0
Jeollabuk-do
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Country [108]
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0
Korea, Republic of
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State/province [108]
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0
Jeollanam-do
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Country [109]
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0
Korea, Republic of
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State/province [109]
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0
Jeonlabuk-do
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Country [110]
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0
Korea, Republic of
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State/province [110]
0
0
Busan
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Country [111]
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0
Korea, Republic of
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State/province [111]
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0
Incheon
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Country [112]
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0
Korea, Republic of
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State/province [112]
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0
Seongnam-si
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Country [113]
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0
Korea, Republic of
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State/province [113]
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0
Seoul
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Country [114]
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0
Netherlands
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State/province [114]
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0
Noord-brabant
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0
Netherlands
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State/province [115]
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0
Zuid-holland
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Country [116]
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0
Netherlands
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State/province [116]
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0
Arnhem
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Country [117]
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0
Netherlands
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State/province [117]
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0
Nijmegen
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0
Norway
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State/province [118]
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0
Akershus
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Country [119]
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0
Norway
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State/province [119]
0
0
Stavanger
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Country [120]
0
0
Peru
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State/province [120]
0
0
Lima
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Country [121]
0
0
Portugal
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State/province [121]
0
0
Braga
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Country [122]
0
0
Portugal
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State/province [122]
0
0
Lisboa
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Country [123]
0
0
Portugal
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State/province [123]
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0
Lisbon
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0
0
Portugal
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State/province [124]
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Porto
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0
0
Singapore
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State/province [125]
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Singapore
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Country [126]
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0
Spain
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State/province [126]
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0
A Coruna
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Spain
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Barcelona
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0
0
Spain
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0
Cantabria
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Country [129]
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Spain
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State/province [129]
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Madrid
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Country [130]
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0
Spain
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State/province [130]
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0
L'Hospitaler De Llobregat
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Country [131]
0
0
Spain
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State/province [131]
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0
Ourense
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Country [132]
0
0
Spain
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State/province [132]
0
0
Valencia
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Country [133]
0
0
Spain
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State/province [133]
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0
Zaragoza
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Country [134]
0
0
Sweden
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State/province [134]
0
0
Jonkoping
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Country [135]
0
0
Sweden
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State/province [135]
0
0
Stockholm
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Country [136]
0
0
Taiwan
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State/province [136]
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0
Kaohsiung City
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0
0
Taiwan
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State/province [137]
0
0
Kaohsiung
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Country [138]
0
0
Taiwan
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State/province [138]
0
0
Taichung
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Country [139]
0
0
Taiwan
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State/province [139]
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0
Tainan City
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Country [140]
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0
Taiwan
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State/province [140]
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0
Tainan
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Country [141]
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0
Taiwan
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State/province [141]
0
0
Taipei
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Country [142]
0
0
United Kingdom
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State/province [142]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen, a wholly owned subsidiary of Pfizer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
RemeGen Co., Ltd.
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
0
0
Merck Sharp & Dohme LLC
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Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05911295
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Seagen Pfizer CT.gov Call Center
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-800-718-1021
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05911295
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