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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02967692
Registration number
NCT02967692
Ethics application status
Date submitted
16/11/2016
Date registered
18/11/2016
Date last updated
22/04/2024
Titles & IDs
Public title
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
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Secondary ID [1]
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2016-002794-35
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Secondary ID [2]
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CPDR001F2301
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Universal Trial Number (UTN)
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Trial acronym
COMBI-i
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Spartalizumab
Other interventions - Placebo
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Trametinib
Experimental: Part 1: Safety run-in Cohort - In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Experimental: Part 2: Biomarker cohort - In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Experimental: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Placebo Comparator: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib - In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Other interventions: Spartalizumab
Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks
Other interventions: Placebo
Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks
Treatment: Drugs: Dabrafenib
Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.
Treatment: Drugs: Trametinib
Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions
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Intervention code [1]
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Other interventions
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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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Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs
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Timepoint [1]
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Up to 8 weeks (Part 1)
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Primary outcome [2]
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Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
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Assessment method [2]
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Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
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Timepoint [2]
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Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
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Primary outcome [3]
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Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
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Assessment method [3]
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Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
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Timepoint [3]
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Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
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Primary outcome [4]
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Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
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Assessment method [4]
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Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
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Timepoint [4]
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Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival is defined as the time from date of randomization to date of death due to any cause
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Timepoint [1]
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Up to death due to any cause, assessed up to approximately 5 years
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Secondary outcome [2]
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Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1
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Assessment method [2]
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ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
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Timepoint [2]
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Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years
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Secondary outcome [3]
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Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1
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Assessment method [3]
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DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
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Timepoint [3]
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From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)
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Secondary outcome [4]
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Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1
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Assessment method [4]
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DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
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Timepoint [4]
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Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year
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Secondary outcome [5]
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Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores
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Assessment method [5]
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The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.
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Timepoint [5]
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From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
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Secondary outcome [6]
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Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores
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Assessment method [6]
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The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.
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Timepoint [6]
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From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
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Secondary outcome [7]
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Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores
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Assessment method [7]
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The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.
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Timepoint [7]
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From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
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Secondary outcome [8]
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Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status
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Assessment method [8]
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The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.
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Timepoint [8]
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From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)
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Secondary outcome [9]
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Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score
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Assessment method [9]
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The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.
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Timepoint [9]
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From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
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Secondary outcome [10]
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Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score
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Assessment method [10]
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The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.
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Timepoint [10]
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From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
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Secondary outcome [11]
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Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression
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Assessment method [11]
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PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having = 1% expression and a negative status was defined as having < 1% expression.
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Timepoint [11]
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Up to disease progression or death due to any cause, up to 2.8 years (Part 3)
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Secondary outcome [12]
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Randomized (Part 3): OS by PD-L1 Expression
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Assessment method [12]
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OS is defined as the time from date of randomization to date of death due to any cause.
OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having = 1% expression and a negative status is defined as having < 1% expression.
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Timepoint [12]
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Up to death due to any cause, up to 5 years
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Secondary outcome [13]
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Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline
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Assessment method [13]
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Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Spartalizumab ADA Incidence
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Assessment method [14]
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Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
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Timepoint [14]
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Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).
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Secondary outcome [15]
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Trough Concentration (Ctrough) for Spartalizumab
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Assessment method [15]
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Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.
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Timepoint [15]
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Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
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Secondary outcome [16]
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Pre-dose Plasma Concentration for Dabrafenib
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Assessment method [16]
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Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.
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Timepoint [16]
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Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
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Secondary outcome [17]
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Pre-dose Plasma Concentration for Trametinib
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Assessment method [17]
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Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.
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Timepoint [17]
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Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
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Secondary outcome [18]
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Number of Participants With Dose Interruptions
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Assessment method [18]
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Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib
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Timepoint [18]
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From baseline to end of treatment, up to 5 years
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Secondary outcome [19]
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Number of Participants With Dose Reductions
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Assessment method [19]
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Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib
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Timepoint [19]
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From baseline to end of treatment, up to 5 years
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Secondary outcome [20]
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Relative Dose Intensity
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Assessment method [20]
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Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity
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Timepoint [20]
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From baseline to end of treatment, up to 5 years
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Eligibility
Key inclusion criteria
Inclusion criteria Part 1: Safety run-in
- Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
- Measurable disease according to RECIST 1.1
- ECOG performance status = 1
Part 2: Biomarker cohort
- Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
- Measurable disease according to RECIST 1.1
- ECOG performance status = 2
Part 3: Double-blind, randomized, placebo-controlled part
- Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
- ECOG performance status = 2
- Measurable disease according to RECIST 1.1
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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
Part 1: Safety run-in
- Subjects with uveal or mucosal melanoma
- Any history of CNS metastases
- Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
- Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to
enrollmen
- Radiation therapy within 4 weeks prior to start of study treatment
- Active autoimmune disease, and/or history of autoimmune disease(s) that required
treatment
Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
- Subjects with uveal or mucosal melanoma
- Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
- Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to
enrollment
- Radiation therapy within 4 weeks prior to start of study treatment
- Clinically active cerebral melanoma metastasis.
- Active autoimmune disease, and/or history of autoimmune disease(s) that required
treatment
Other protocol-defined Inclusion/Exclusion may apply.
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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 administering 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
17/02/2017
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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
2/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
569
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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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Novartis Investigative Site - Gateshead
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Recruitment hospital [2]
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Novartis Investigative Site - North Sydney
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Recruitment hospital [3]
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Novartis Investigative Site - Greenslopes
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Recruitment hospital [4]
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Novartis Investigative Site - Prahran
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Recruitment hospital [5]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2290 - Gateshead
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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4120 - Greenslopes
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Recruitment postcode(s) [4]
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3181 - Prahran
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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California
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0
United States of America
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Kansas
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0
United States of America
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Maryland
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0
United States of America
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0
Nebraska
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0
United States of America
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0
New York
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0
United States of America
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0
Pennsylvania
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0
United States of America
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0
Tennessee
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0
United States of America
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Texas
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0
United States of America
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Utah
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0
Argentina
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0
Buenos Aires
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0
Argentina
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Santa Fe
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Austria
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Tyrol
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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0
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Austria
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St Poelten
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Belgium
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Brussel
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Belgium
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Bruxelles
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Brazil
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Rio de Janeiro
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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0
0
Canada
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British Columbia
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Canada
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Ontario
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0
Canada
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody
(Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in
unresectable or metastatic BRAF V600 mutant melanoma
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02967692
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Contacts
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02967692
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