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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05562830
Registration number
NCT05562830
Ethics application status
Date submitted
28/09/2022
Date registered
3/10/2022
Date last updated
3/07/2023
Titles & IDs
Public title
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
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Scientific title
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A
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Secondary ID [1]
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MK-3475-04A
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Secondary ID [2]
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3475-04A
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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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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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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
Other interventions - Zilovertamab vedotin
Experimental: Zilovertamab vedotin - Participants will receive zilovertamab vedotin 2mg/kg administered on Day 1 and Day 8 of each 3 week cycle (Q3W) until documented disease progression or any other discontinuation criterion is met.
Other interventions: Zilovertamab vedotin
Administered via intravenous (IV) infusion on day 1 and day 8 of Q3W cycles
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Intervention code [1]
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Other interventions
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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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Percentage of Participants Who Experienced At Least One Adverse Event (AE)
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Assessment method [1]
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
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Timepoint [1]
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Up to approximately 5 years
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Primary outcome [2]
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Percentage of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [2]
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment
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Timepoint [2]
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Up to approximately 5 years
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Primary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants who achieve a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [1]
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Up to approximately 2 years
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of locally advanced/unresectable
or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
- PD-1/L1 refractory locally advanced or mUC as evidenced by:
EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1
monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as
monotherapy, or in combination with other checkpoint inhibitors or other therapies OR
disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for
muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
- Participants must provide an archival tumor tissue sample or newly obtained core or
excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and
adequate for biomarker evaluation.
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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 additional nonurothelial malignancy that is progressing or has required active
treatment within 3 years prior to study randomization/allocation.
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before randomization/allocation.
- Active infection requiring systemic therapy.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
- Known history of human immunodeficiency virus (HIV).
- Known history of hepatitis B or known hepatitis C virus infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
16/11/2022
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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
28/10/2027
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Indiana
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Missouri
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Ohio
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United States of America
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Pennsylvania
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Chile
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Region M. De Santiago
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Denmark
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Hovedstaden
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Israel
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Haifa
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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State/province [14]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This substudy is part of an umbrella platform study which is designed to evaluate
investigational agents with or without pembrolizumab in participants with urothelial
carcinoma who are in need of new treatment options. Substudy 04A will enroll participants
with locally advanced or mUC whose disease is resistant to treatment with programmed cell
death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling
assignment of investigational treatments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05562830
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05562830
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