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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04221945
Registration number
NCT04221945
Ethics application status
Date submitted
23/12/2019
Date registered
9/01/2020
Titles & IDs
Public title
Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
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Scientific title
A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)
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Secondary ID [1]
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MK-3475-A18
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Secondary ID [2]
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3475-A18
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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:
Uterine Cervical Neoplasms
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Placebo for pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Other - External Beam Radiotherapy (EBRT)
Treatment: Other - Brachytherapy
Experimental: chemoradiotherapy + pembrolizumab - Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Experimental: chemoradiotherapy + placebo for pembrolizumab - Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Treatment: Other: Pembrolizumab
IV infusion
Treatment: Drugs: Placebo for pembrolizumab
IV infusion
Treatment: Drugs: Cisplatin
IV infusion
Treatment: Other: External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Treatment: Other: Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
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Timepoint [1]
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Up to approximately 38 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is the time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 46 months
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Secondary outcome [1]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
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Timepoint [1]
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Up to approximately 38 months
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Secondary outcome [2]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
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Assessment method [2]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months.
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Timepoint [2]
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Up to approximately 38 months
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Secondary outcome [3]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [3]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months.
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Timepoint [3]
0
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Up to approximately 38 months
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Secondary outcome [4]
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Overall Survival (OS) at Month 36
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Assessment method [4]
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OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months.
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Timepoint [4]
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Up to approximately 46 months
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Secondary outcome [5]
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Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by the Investigator
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Assessment method [5]
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For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months.
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Timepoint [5]
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0
Up to approximately 38 months
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Secondary outcome [6]
0
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Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [6]
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For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months.
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Timepoint [6]
0
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Up to approximately 38 months
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Secondary outcome [7]
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
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Assessment method [7]
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ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.
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Timepoint [7]
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Up to approximately 46 months
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Secondary outcome [8]
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [8]
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ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.
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Timepoint [8]
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Up to approximately 46 months
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Secondary outcome [9]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
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Assessment method [9]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
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Timepoint [9]
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Up to approximately 38 months
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Secondary outcome [10]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [10]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =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 =5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
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Timepoint [10]
0
0
Up to approximately 38 months
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Secondary outcome [11]
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Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
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Assessment method [11]
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OS is the time from randomization to death due to any cause.
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Timepoint [11]
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Up to approximately 46 months
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Secondary outcome [12]
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Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [12]
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OS is the time from randomization to death due to any cause.
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Timepoint [12]
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Up to approximately 46 months
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Secondary outcome [13]
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Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
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Assessment method [13]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) on next-line treatment or death due to any cause, whichever occurs first, as assessed by the investigator.
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Timepoint [13]
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Up to approximately 46 months
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Secondary outcome [14]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
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Assessment method [14]
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The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.
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Timepoint [14]
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Baseline and up to approximately 46 months
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Secondary outcome [15]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
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Assessment method [15]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
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Timepoint [15]
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Baseline and up to approximately 46 months
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Secondary outcome [16]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
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Assessment method [16]
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The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.
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Timepoint [16]
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Baseline and up to approximately 46 months
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Secondary outcome [17]
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Number of Participants Who Experience One or More Adverse Events (AEs)
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Assessment method [17]
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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 [17]
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Up to approximately 46 months
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Secondary outcome [18]
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Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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Assessment method [18]
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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 [18]
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Up to approximately 46 months
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Eligibility
Key inclusion criteria
* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or FIGO 2014 Stages III-IVA
* Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
* Female participants must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
* Female participants must abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment
* Has provided a tissue sample from a core incisional or excisional biopsy of a tumor lesion
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology
* Has adequate organ function within 7 days prior to the start of study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has excluded subtypes of LACC
* Has FIGO 2014 Stage IVB disease
* Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy
* Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy or considered mild and not clinically significant in the opinion of the investigator
* Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has received treatment with systemic immunostimulatory agents, colony stimulating factors, interferons, interleukins and vaccine combinations within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has any contraindication to the use of cisplatin
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of Human Immunodeficiency Virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
* Has evidence of metastatic disease per RECIST 1.1 including lymph nodes above the first lumbar vertebra (L1) cephalad body, in the inguinal region
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
12/05/2020
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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
17/01/2025
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Actual
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Sample size
Target
980
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital ( Site 0973) - Westmead
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Recruitment hospital [2]
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Royal Brisbane and Women s Hospital ( Site 0972) - Herston
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Recruitment hospital [3]
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Monash Health-Monash Medical Centre ( Site 0970) - Clayton
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre ( Site 0971) - Melbourne
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Recruitment hospital [5]
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St John of God Subiaco Hospital ( Site 0969) - Subiaco
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Recruitment postcode(s) [1]
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0
2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Indiana
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Kentucky
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United States of America
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Louisiana
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Michigan
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Minnesota
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New Mexico
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Texas
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Virginia
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Austria
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Steiermark
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Austria
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Tirol
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Hainaut
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams-Brabant
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Brazil
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State/province [28]
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Minas Gerais
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Brazil
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State/province [29]
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Rio Grande Do Norte
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0
0
Brazil
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State/province [30]
0
0
Sao Paulo
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Country [31]
0
0
Brazil
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Rio de Janeiro
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Ontario
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Chile
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Araucania
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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China
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Anhui
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China
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Beijing
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China
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Heilongjiang
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China
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China
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Shanghai
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China
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Sichuan
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China
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Xinjiang
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China
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Zhejiang
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Antioquia
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Distrito Capital De Bogota
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Valle Del Cauca
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Czechia
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Praha 10
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Doubs
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France
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France
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Germany
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Bayern
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Achaia
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Attiki
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Greece
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Thessaloniki
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Guatemala
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Guatemala
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Quetzaltenango
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Hungary
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Budapest
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Hungary
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Debrecen
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Cork
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Ireland
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Dublin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Piemonte
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Italy
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Roma
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Italy
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Bologna
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Italy
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Lecce
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Italy
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Napoli
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Italy
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Torino
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Iwate
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Japan
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Okinawa
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Kagoshima
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Japan
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Osaka
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Korea, Republic of
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Kyonggi-do
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Seoul
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Norway
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Hordaland
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Oslo
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Ariqipa
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Peru
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La Libertad
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Peru
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Lima
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Russian Federation
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Russian Federation
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Russian Federation
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Moskva
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Russian Federation
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Russian Federation
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Barcelona
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La Coruna
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Spain
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Madrid
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Jaen
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Stockholms Lan
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Taipei
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Taoyuan
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Khon Kaen
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Krung Thep Maha Nakhon
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Thailand
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Songkhla
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Chiang Mai
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Istanbul
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Turkey
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Adana
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Turkey
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Ankara
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Ukraine
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Kharkivska Oblast
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Ukraine
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Lvivska Oblast
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United Kingdom
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England
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United Kingdom
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London, City Of
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United Kingdom
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Surrey
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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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Other collaborator category [1]
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Other
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Name [1]
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GOG Foundation
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Other
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
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Trial website
https://clinicaltrials.gov/study/NCT04221945
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Trial related presentations / publications
Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejia F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampe R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20.
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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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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
Type
Citations or Other Details
Journal
Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M...
[
More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT04221945