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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05845814
Registration number
NCT05845814
Ethics application status
Date submitted
26/04/2023
Date registered
6/05/2023
Titles & IDs
Public title
A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)
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Scientific title
A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B
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Secondary ID [1]
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MK-3475-04B
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Secondary ID [2]
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3475-04B
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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:
Metastatic Urothelial Carcinoma
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Urothelial Neoplasms
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Condition category
Condition code
Cancer
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0
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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
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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: Other - Coformulated favezelimab/pembrolizumab
Treatment: Other - Coformulated vibostolimab/pembrolizumab
Other interventions - EV
Treatment: Other - Pembrolizumab
Experimental: Arm A: Coformulated favezelimab/pembrolizumab plus EV - Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) as an intravenous (IV) infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.
Experimental: Arm B: Coformulated vibostolimab/pembrolizumab plus EV - Participants will receive coformulated vibostolimab/pembrolizumab (200 mg/200 mg) as an IV infusion on Day 1 of every 3-week cycle, for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.
Active comparator: Arm C: Pembrolizumab plus EV - Participants will receive 200 mg pembrolizumab as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle, until disease progression, intolerable toxicity, or investigator decision.
Treatment: Other: Coformulated favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion
Treatment: Other: Coformulated vibostolimab/pembrolizumab
Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion
Other interventions: EV
1.25 mg/kg IV infusion
Treatment: Other: Pembrolizumab
200 mg IV infusion
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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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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Part 1: Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). ORR will be reported for participants in Part 1.
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Timepoint [1]
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Up to ~4 years
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Primary outcome [2]
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Part 1: Percentage of Participants experiencing an Adverse Event (AE)
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Assessment method [2]
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An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 1 will be reported.
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Timepoint [2]
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0
Up to ~4 years
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Primary outcome [3]
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Part 1: Percentage of Participants who Discontinue study interventions due to an AE
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Assessment method [3]
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An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study interventions due to an AE in Part 1 will be reported.
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Timepoint [3]
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0
Up to ~4 years
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Primary outcome [4]
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Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)
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Assessment method [4]
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A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.
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Timepoint [4]
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Up to 21 days
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Primary outcome [5]
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Part 2: Progression Free Survival (PFS)
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Assessment method [5]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PFS will be reported for participants in Part 2.
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Timepoint [5]
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Up to ~4 years
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Secondary outcome [1]
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Part 1: PFS
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PFS will be reported for participants in Part 1.
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Timepoint [1]
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0
Up to ~4 years
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Secondary outcome [2]
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Part 1: Duration of Response (DOR)
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Assessment method [2]
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For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR will be reported for participants in Part 1.
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Timepoint [2]
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0
Up to ~4 years
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Secondary outcome [3]
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Part 2: Overall Survival (OS)
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Assessment method [3]
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OS is defined as the time from randomization to death due to any cause. OS will be reported for participants in Part 2.
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Timepoint [3]
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Up to ~4 years
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Secondary outcome [4]
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Part 2: ORR
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Assessment method [4]
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ORR is defined as the percentage of participants who achieve a confirmed CR or PR per RECIST 1.1 as assessed by BICR. ORR will be reported for participants in Part 2.
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Timepoint [4]
0
0
Up to ~4 years
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Secondary outcome [5]
0
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Part 2: DOR
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Assessment method [5]
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For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR will be reported for participants in Part 2.
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Timepoint [5]
0
0
Up to ~4 years
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Secondary outcome [6]
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Part 2: Percentage of Participants experiencing an Adverse Event (AE)
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Assessment method [6]
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An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 2 will be reported.
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Timepoint [6]
0
0
Up to ~4 years
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Secondary outcome [7]
0
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Part 2: Percentage of Participants who Discontinue study interventions due to an AE
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Assessment method [7]
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0
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study interventions due to an AE in Part 2 will be reported.
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Timepoint [7]
0
0
Up to ~4 years
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Secondary outcome [8]
0
0
Part 2: Percentage of Participants with Dose-limiting toxicities (DLT)
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Assessment method [8]
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0
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 2 will be reported.
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Timepoint [8]
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0
Up to 21 days
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Secondary outcome [9]
0
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Part 1: Mean Change from baseline in the global health status/quality of life of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLC-C30) (Items 29 and 30)
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Assessment method [9]
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Participants are asked to answer questions 29 and 30 from the EORTC QLC-C30. Questions 29 and 30 use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 1.
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Timepoint [9]
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Baseline and up to ~4 years
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Secondary outcome [10]
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Part 1: Mean Change from baseline in the physical functioning scale of the EORTC QLQ-C30
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Assessment method [10]
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Participants are asked to answer questions about their physical functioning from the EORTC QLC-C30. These questions use a 4-point scale (1=not at all to 4=very much) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 1.
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Timepoint [10]
0
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Baseline and up to ~4 years
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Secondary outcome [11]
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Part 1: Mean Change from Baseline in the European Quality of Life 5 Dimensions, 5-level Questionnaire (EQ-5D-5L) visual analog score (VAS)
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Assessment method [11]
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The EQ-5D-5L is a descriptive five-dimensional system of evaluation. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants rate each dimension on 5 levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 1.
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Timepoint [11]
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0
Baseline and up to ~4 years
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Secondary outcome [12]
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Part 2: Mean Change from baseline in the global health status/quality of life of the EORTC QLC-C30 (Items 29 and 30)
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Assessment method [12]
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Participants are asked to answer questions 29 and 30 from the EORTC QLC-C30. Questions 29 and 30 use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 2.
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Timepoint [12]
0
0
Baseline and up to ~4 years
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Secondary outcome [13]
0
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Part 2: Mean Change from baseline in the physical functioning scale of the EORTC QLQ-C30
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Assessment method [13]
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Participants are asked to answer questions about their physical functioning from the EORTC QLC-C30. These questions use a 4-point scale (1=not at all to 4=very much) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 2.
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Timepoint [13]
0
0
Baseline and up to ~4 years
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Secondary outcome [14]
0
0
Part 2: Mean Change from Baseline in the EQ-5D-5L visual analog score (VAS)
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Assessment method [14]
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0
The EQ-5D-5L is a descriptive five-dimensional system of evaluation. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants rate each dimension on 5 levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The mean change from baseline will be reported for Part 2.
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Timepoint [14]
0
0
Baseline and up to ~4 years
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Secondary outcome [15]
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Part 1: Time-to-Deterioration (TTD) for the global health status/quality of life of the EORTC QLQ-C30 (Items 29 and 30)
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Assessment method [15]
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Participants are asked to answer questions 29 and 30 from the EORTC QLC-C30. Questions 29 and 30 use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as =10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported for Part 1.
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Timepoint [15]
0
0
Up to ~4 years
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Secondary outcome [16]
0
0
Part 1: TTD for the physical functioning scale of the EORTC QLQ-C30
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Assessment method [16]
0
0
Participants are asked to answer questions about their physical functioning from the EORTC QLC-C30. These questions use a 4-point scale (1=not at all to 4=very much) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as =10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported for Part 1.
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Timepoint [16]
0
0
Up to ~4 years
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Secondary outcome [17]
0
0
Part 1: TTD for the EQ-5D-5L VAS
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Assessment method [17]
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The EQ-5D-5L is a descriptive five-dimensional system of evaluation. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants rate each dimension on 5 levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. TTD is defined as the time from the first EQ-5D-5L VAS assessment to deterioration (defined as =7-point decrease in EQ-5D-5L VAS score more from baseline) or death, whichever occurs first. The TTD in EQ-5D-5L VAS score of participants will be reported for Part 1.
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Timepoint [17]
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Up to ~4 years
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Secondary outcome [18]
0
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Part 2: TTD for the global health status/quality of life of the EORTC QLQ-C30 (Items 29 and 30)
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Assessment method [18]
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Participants are asked to answer questions 29 and 30 from the EORTC QLC-C30. Questions 29 and 30 use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as =10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported for Part 2.
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Timepoint [18]
0
0
Up to ~4 years
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Secondary outcome [19]
0
0
Part 2: TTD for the physical functioning scale of the EORTC QLQ-C30
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Assessment method [19]
0
0
Participants are asked to answer questions about their physical functioning from the EORTC QLC-C30. These questions use a 4-point scale (1=not at all to 4=very much) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as =10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported for Part 2.
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Timepoint [19]
0
0
Up to ~4 years
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Secondary outcome [20]
0
0
Part 2: TTD for the EQ-5D-5L VAS
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Assessment method [20]
0
0
The EQ-5D-5L is a descriptive five-dimensional system of evaluation. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants rate each dimension on 5 levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. TTD is defined as the time from the first EQ-5D-5L VAS assessment to deterioration (defined as =7-point decrease in EQ-5D-5L VAS score more from baseline) or death, whichever occurs first. The TTD in EQ-5D-5L VAS score of participants will be reported for Part 2.
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Timepoint [20]
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Up to ~4 years
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Eligibility
Key inclusion criteria
* Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
* Participants with mixed histology are eligible provided the urothelial component is =50% (and <10% plasmacytoid component)
* Participants whose tumors contain any neuroendocrine component are not eligible (variant histology to be confirmed locally)
* Must not have received prior systemic therapy for la/mUC. The following therapies in earlier disease setting (eg, muscle-invasive urothelial carcinoma (MIUC)) are permitted:
* Participants that received neoadjuvant or adjuvant chemotherapy are permitted.
* Participants who received anti- programmed cell death 1 protein (PD-1) or programmed cell death ligand 1 (PD-L1) therapy for an earlier disease stage (eg, NMIBC, MIUC) with progression/recurrence >12 months from completion of therapy are permitted.
* 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. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable.
* Any AEs due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement or with <Grade 2 neuropathy are eligible.
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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
* Has a known additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
* Central nervous system (CNS) metastases are permitted on-study if all of the following are true: a) CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis; b) the participant is on a stable dose of =10 mg/day of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment); c) participant does not have leptomeningeal disease.
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
* Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator.
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
* Has a history of uncontrolled diabetes.
* Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection (viral, bacterial, or fungal) requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has hepatitis B or hepatitis C virus infection.
* Has had major surgery within 4 weeks prior to first dose of study intervention.
* Has had an allogenic tissue/solid organ transplant
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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 1
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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
23/06/2023
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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
31/05/2027
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Actual
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Sample size
Target
390
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
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Recruitment hospital [2]
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Austin Health-Cancer Clinical Trials Centre ( Site 3950) - Heidelberg
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Recruitment postcode(s) [1]
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0
4029 - Brisbane
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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0
0
United States of America
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State/province [2]
0
0
Colorado
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0
0
United States of America
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State/province [3]
0
0
Georgia
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0
0
United States of America
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State/province [4]
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0
Indiana
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Missouri
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0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
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0
Ohio
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Country [8]
0
0
United States of America
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State/province [8]
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0
Pennsylvania
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Utah
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Country [10]
0
0
Canada
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State/province [10]
0
0
Ontario
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Country [11]
0
0
Chile
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State/province [11]
0
0
Region M. De Santiago
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Country [12]
0
0
Chile
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State/province [12]
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0
Valparaiso
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Country [13]
0
0
Chile
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State/province [13]
0
0
Antofagasta
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0
0
France
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State/province [14]
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0
Aquitaine
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Country [15]
0
0
France
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State/province [15]
0
0
Cote-d Or
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Country [16]
0
0
France
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State/province [16]
0
0
Haute-Garonne
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Country [17]
0
0
France
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State/province [17]
0
0
Ile-de-France
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Country [18]
0
0
France
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State/province [18]
0
0
Rhone
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Country [19]
0
0
Israel
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State/province [19]
0
0
Haifa
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Country [20]
0
0
Israel
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State/province [20]
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0
Petah Tikva
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Country [21]
0
0
Israel
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State/province [21]
0
0
Ramat Gan
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Country [22]
0
0
Italy
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State/province [22]
0
0
Lombardia
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0
0
Italy
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State/province [23]
0
0
Napoli
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0
0
Korea, Republic of
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State/province [24]
0
0
Seoul
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Country [25]
0
0
Netherlands
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State/province [25]
0
0
Limburg
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0
0
Netherlands
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State/province [26]
0
0
Noord-Holland
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Country [27]
0
0
Netherlands
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State/province [27]
0
0
Zuid-Holland
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0
0
Spain
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State/province [28]
0
0
Barcelona
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Country [29]
0
0
Spain
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State/province [29]
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Madrid
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Country [30]
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Taiwan
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Kaohsiung
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Country [31]
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Taiwan
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State/province [31]
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Tainan
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Country [32]
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Taiwan
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State/province [32]
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Taipei
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Country [33]
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United Kingdom
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State/province [33]
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London, City Of
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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 study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.
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Trial website
https://clinicaltrials.gov/study/NCT05845814
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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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Merck Sharp & Dohme LLC
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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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/NCT05845814