- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05845814
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)
February 16, 2024 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Active, not recruiting
Detailed Description
The master study for this substudy is MK-3475-U04/KEYMAKER-U04.
The master study will not be screening any participants and will not be registered.
Study Type
Interventional
Enrollment (Estimated)
390
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health-Cancer Clinical Trials Centre ( Site 3950)
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105)
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108)
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre ( Site 3106)
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Antofagasta, Chile, 1240000
- Bradford Hill Norte ( Site 3152)
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Region M. De Santiago
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Santiago, Region M. De Santiago, Chile, 7500921
- FALP-UIDO ( Site 3151)
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Santiago, Region M. De Santiago, Chile, 8420383
- Bradfordhill-Clinical Area ( Site 3155)
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- ONCOCENTRO APYS-ACEREY ( Site 3158)
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Aquitaine
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Bordeaux, Aquitaine, France, 33075
- CHU de Bordeaux Hop St ANDRE ( Site 3607)
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Cote-d Or
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Dijon, Cote-d Or, France, 21079
- Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608)
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31059
- Oncopole Claudius Regaud ( Site 3610)
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Ile-de-France
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Paris, Ile-de-France, France, 75015
- Hôpital Européen Georges Pompidou ( Site 3605)
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Rhone
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Pierre-Bénite, Rhone, France, 69310
- centre hospitalier lyon sud ( Site 3606)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 3501)
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Petah Tikva, Israel, 4941492
- Rabin Medical Center-Oncology ( Site 3504)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center-ONCOLOGY ( Site 3503)
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Napoli, Italy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406)
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Lombardia
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Milan, Lombardia, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405)
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Milano, Lombardia, Italy, 20132
- Ospedale San Raffaele-Oncologia Medica ( Site 3403)
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903)
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Seoul, Korea, Republic of, 05505
- Asan Medical Center-Department of Oncology ( Site 3901)
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center ( Site 3902)
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Limburg
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Maastricht, Limburg, Netherlands, 6229 HX
- Maastricht UMC+ ( Site 3304)
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1066 CX
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302)
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Erasmus Medisch Centrum-Medical Oncology ( Site 3303)
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron ( Site 3767)
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Madrid, Spain, 28040
- Hospital Clinico San Carlos ( Site 3765)
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Kaohsiung, Taiwan, 83301
- Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 3802)
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 3803)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital-Oncology ( Site 3801)
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London, City Of
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London, London, City Of, United Kingdom, EC1A 7BE
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3206)
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London, London, City Of, United Kingdom, SW3 6JJ
- ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 3201)
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California
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La Jolla, California, United States, 92093
- Moores Cancer Center ( Site 3028)
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Orange, California, United States, 92868
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045)
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Colorado
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Aurora, Colorado, United States, 80045
- Anschutz Cancer Pavilion ( Site 3017)
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine ( Site 3043)
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Melvin and Bren Simon Cancer Center ( Site 3011)
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine ( Site 3038)
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai ( Site 3018)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center ( Site 3031)
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic-Taussig Cancer Center ( Site 3036)
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Hillman Cancer Center ( Site 3014)
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion
Other Names:
1.25 mg/kg IV infusion
Other Names:
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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.
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1.25 mg/kg IV infusion
Other Names:
Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion
Other Names:
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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.
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200 mg IV infusion
Other Names:
1.25 mg/kg IV infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Objective Response Rate (ORR)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 1: Percentage of Participants experiencing an Adverse Event (AE)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 1: Percentage of Participants who Discontinue study interventions due to an AE
Time Frame: Up to ~4 years
|
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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Up to ~4 years
|
Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)
Time Frame: Up to 21 days
|
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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Up to 21 days
|
Part 2: Progression Free Survival (PFS)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: PFS
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 1: Duration of Response (DOR)
Time Frame: Up to ~4 years
|
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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Up to ~4 years
|
Part 2: Overall Survival (OS)
Time Frame: Up to ~4 years
|
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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Up to ~4 years
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Part 2: ORR
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: DOR
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: Percentage of Participants experiencing an Adverse Event (AE)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: Percentage of Participants who Discontinue study interventions due to an AE
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: Percentage of Participants with Dose-limiting toxicities (DLT)
Time Frame: Up to 21 days
|
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.
|
Up to 21 days
|
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)
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 1: Mean Change from baseline in the physical functioning scale of the EORTC QLQ-C30
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 1: Mean Change from Baseline in the European Quality of Life 5 Dimensions, 5-level Questionnaire (EQ-5D-5L) visual analog score (VAS)
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 2: Mean Change from baseline in the global health status/quality of life of the EORTC QLC-C30 (Items 29 and 30)
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 2: Mean Change from baseline in the physical functioning scale of the EORTC QLQ-C30
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 2: Mean Change from Baseline in the EQ-5D-5L visual analog score (VAS)
Time Frame: Baseline and up to ~4 years
|
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.
|
Baseline and up to ~4 years
|
Part 1: Time-to-Deterioration (TTD) for the global health status/quality of life of the EORTC QLQ-C30 (Items 29 and 30)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 1: TTD for the physical functioning scale of the EORTC QLQ-C30
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 1: TTD for the EQ-5D-5L VAS
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: TTD for the global health status/quality of life of the EORTC QLQ-C30 (Items 29 and 30)
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: TTD for the physical functioning scale of the EORTC QLQ-C30
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Part 2: TTD for the EQ-5D-5L VAS
Time Frame: Up to ~4 years
|
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.
|
Up to ~4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
April 26, 2023
First Submitted That Met QC Criteria
April 26, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3475-04B
- MK-3475-04B (Other Identifier: Merck)
- 2022-001371-14 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
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Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
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National Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Metastatic Renal Pelvis and Ureter Urothelial CarcinomaUnited States
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University of UtahNational Cancer Institute (NCI)RecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Urothelial Carcinoma, Sarcomatoid VariantUnited States
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Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
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Emory UniversityNational Cancer Institute (NCI); ExelixisRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma With Squamous DifferentiationUnited States
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National Cancer Institute (NCI)CompletedMetastatic Prostate Carcinoma | Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Stage IV Renal... and other conditionsUnited States, Puerto Rico
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Emory UniversityNational Cancer Institute (NCI)RecruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Renal Pelvis Cancer AJCC v8 | Stage IV Ureter Cancer... and other conditionsUnited States
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Shanghai Miracogen Inc.RecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial CancerChina
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Incyte CorporationTerminatedMetastatic Urothelial Carcinoma | Unresectable Urothelial CarcinomaSpain, France, United States, Italy, Japan, Ireland, Slovakia, Austria, Belgium, Canada, Finland, Germany, Poland, Portugal, Romania, United Kingdom
Clinical Trials on Pembrolizumab
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Incyte CorporationMerck Sharp & Dohme LLCCompletedMelanomaUnited States, France, Italy, United Kingdom, Spain, Belgium, Israel, Mexico, Japan, Canada, Netherlands, Sweden, Korea, Republic of, Australia, Russian Federation, Chile, Germany, Poland, Ireland, New Zealand, Denmark, Switzerland, South Africa
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Merck Sharp & Dohme LLCCompletedMelanomaAustralia, South Africa, Spain, Sweden
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University Medical Center GroningenCompleted
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Acerta Pharma BVMerck Sharp & Dohme LLCCompletedMetastatic Urothelial CarcinomaUnited States
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HUYABIO International, LLC.Active, not recruitingNon Small Cell Lung CancerUnited States
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Prof. Dr. Matthias PreusserUnknownPrimary Central Nervous System LymphomaAustria
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Sichuan UniversityGeneplus-Beijing Co. Ltd.RecruitingNon-small Cell Lung CancerChina
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Chinese University of Hong KongCompletedAcral Lentiginous MelanomaHong Kong
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Yonsei UniversityNot yet recruitingMucosal Melanoma | Acral MelanomaKorea, Republic of