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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02460224
Registration number
NCT02460224
Ethics application status
Date submitted
9/05/2015
Date registered
2/06/2015
Titles & IDs
Public title
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
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Scientific title
A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies
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Secondary ID [1]
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2015-000449-21
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Secondary ID [2]
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CLAG525X2101C
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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:
Advanced Solid Tumors
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LAG525
Treatment: Drugs - PDR001
Experimental: Phase 1: LAG525 1 mg/kg Q2W - Single-agent LAG525 1 mg/kg Q2W
Experimental: Phase 1: LAG525 3 mg/kg Q2W - Single-agent LAG525 3 mg/kg Q2W
Experimental: Phase 1: LAG525 5 mg/kg Q2W - Single-agent LAG525 5 mg/kg Q2W
Experimental: Phase 1: LAG525 10 mg/kg Q2W - Single-agent LAG525 10 mg/kg Q2W
Experimental: Phase 1: LAG525 15 mg/kg Q2W - Single-agent LAG525 15 mg/kg Q2W
Experimental: Phase 1: LAG525 240 mg Q2W - Single-agent LAG525 240 mg Q2W
Experimental: Phase 1: LAG525 400 mg Q2W - Single-agent LAG525 400 mg Q2W
Experimental: Phase 1: LAG525 3 mg/kg Q4W - Single-agent LAG525 3 mg/kg Q4W
Experimental: Phase 1: LAG525 5 mg/kg Q4W - Single-agent LAG525 5 mg/kg Q4W
Experimental: Phase 1: LAG525 10 mg/kg Q4W - Single-agent LAG525 10 mg/kg Q4W
Experimental: Phase 1: LAG525 400 mg Q4W - Single-agent LAG525 400 mg Q4W
Experimental: Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W - Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Experimental: Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W - Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W - Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W - Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W - Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Experimental: Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Experimental: Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Experimental: Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Experimental: Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W - Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Experimental: Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Experimental: Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Experimental: Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Experimental: Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Experimental: Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Experimental: Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Experimental: Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Treatment: Drugs: LAG525
LAG525 was administered via intravenous (i.v.) infusion
Treatment: Drugs: PDR001
PDR001 was administered via i.v. infusion
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Intervention code [1]
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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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Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade = 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
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Timepoint [1]
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15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
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Primary outcome [2]
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Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
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Assessment method [2]
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Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, 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 diameters of all target lesions, taking as reference the baseline sum of diameters.
ORR is reported by tumor type.
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Timepoint [2]
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From start of treatment until end of treatment, assessed up to 2.6 years
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Secondary outcome [1]
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Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
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Timepoint [1]
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From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
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Secondary outcome [2]
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Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [2]
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Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
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Timepoint [2]
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0
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
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Secondary outcome [3]
0
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Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
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Assessment method [3]
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Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.
Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
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Timepoint [3]
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0
From start of treatment until end of treatment, assessed up to 4.4 years.
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Secondary outcome [4]
0
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Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
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Assessment method [4]
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Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.
The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
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Timepoint [4]
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From start of treatment until end of treatment, assessed up to 2.6 years.
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Secondary outcome [5]
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Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
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Assessment method [5]
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Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).
Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.
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Timepoint [5]
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From start of treatment until end of treatment, assessed up to 4.4 years.
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Secondary outcome [6]
0
0
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
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Assessment method [6]
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Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).
The RDI of both study drugs is reported for each tumor type.
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Timepoint [6]
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From start of treatment until end of treatment, assessed up to 2.6 years.
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Secondary outcome [7]
0
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Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
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Assessment method [7]
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Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
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Timepoint [7]
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0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [8]
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0
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
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Assessment method [8]
0
0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
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Timepoint [8]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [9]
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0
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
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Assessment method [9]
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Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
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Timepoint [9]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [10]
0
0
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
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Assessment method [10]
0
0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
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Timepoint [10]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [11]
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Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
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Assessment method [11]
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0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
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Timepoint [11]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [12]
0
0
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
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Assessment method [12]
0
0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
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Timepoint [12]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [13]
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0
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
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Assessment method [13]
0
0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
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Timepoint [13]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [14]
0
0
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
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Assessment method [14]
0
0
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
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Timepoint [14]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [15]
0
0
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
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Assessment method [15]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
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Timepoint [15]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [16]
0
0
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
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Assessment method [16]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Query!
Timepoint [16]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [17]
0
0
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
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Assessment method [17]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Query!
Timepoint [17]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [18]
0
0
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
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Assessment method [18]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Query!
Timepoint [18]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [19]
0
0
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
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Assessment method [19]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Query!
Timepoint [19]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [20]
0
0
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
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Assessment method [20]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Query!
Timepoint [20]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [21]
0
0
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
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Assessment method [21]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Query!
Timepoint [21]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [22]
0
0
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
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Assessment method [22]
0
0
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Query!
Timepoint [22]
0
0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
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Secondary outcome [23]
0
0
Phase 1: Number of Participants With Anti-LAG525 Antibodies
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Assessment method [23]
0
0
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
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Timepoint [23]
0
0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
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Secondary outcome [24]
0
0
Phase 2: Number of Participants With Anti-LAG525 Antibodies
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Assessment method [24]
0
0
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
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Timepoint [24]
0
0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
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Secondary outcome [25]
0
0
Phase 1: Number of Participants With Anti-PDR001 Antibodies
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Assessment method [25]
0
0
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
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Timepoint [25]
0
0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
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Secondary outcome [26]
0
0
Phase 2: Number of Participants With Anti-PDR001 Antibodies
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Assessment method [26]
0
0
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
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Timepoint [26]
0
0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
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Secondary outcome [27]
0
0
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
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Assessment method [27]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).
For RECIST v1.1, 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 diameters of all target lesions, taking as reference the baseline sum of diameters.
ORR is reported for ROW and Japanese patients.
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Timepoint [27]
0
0
From start of treatment until end of treatment, assessed up to 4.4 years
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Secondary outcome [28]
0
0
Phase 1: Overall Response Rate (ORR) Per irRC
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Assessment method [28]
0
0
TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.
ORR is reported for ROW and Japanese patients.
Query!
Timepoint [28]
0
0
From start of treatment until end of treatment, assessed up to 4.4 years
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Secondary outcome [29]
0
0
Phase 2: Overall Response Rate (ORR) Per irRC
Query!
Assessment method [29]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.
ORR is reported by tumor type.
Query!
Timepoint [29]
0
0
From start of treatment until end of treatment, assessed up to 2.6 years
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Secondary outcome [30]
0
0
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
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Assessment method [30]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).
For RECIST v1.1, 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 diameters 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 progression.
DCR is reported for ROW and Japanese patients.
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Timepoint [30]
0
0
From start of treatment until end of treatment, assessed up to 4.4 years
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Secondary outcome [31]
0
0
Phase 1: Disease Control Rate (DCR) Per irRC
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Assessment method [31]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression.
DCR is reported for ROW and Japanese patients.
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Timepoint [31]
0
0
From start of treatment until end of treatment, assessed up to 4.4 years
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Secondary outcome [32]
0
0
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
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Assessment method [32]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).
For RECIST v1.1, 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 diameters 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 progression.
DCR is reported by tumor type.
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Timepoint [32]
0
0
From start of treatment until end of treatment, assessed up to 2.6 years
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Secondary outcome [33]
0
0
Phase 2: Disease Control Rate (DCR) Per irRC
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Assessment method [33]
0
0
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression.
DCR is reported by tumor type.
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Timepoint [33]
0
0
From start of treatment until end of treatment, assessed up to 2.6 years
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Secondary outcome [34]
0
0
Phase 1: Duration of Response (DOR) Per RECIST 1.1
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Assessment method [34]
0
0
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
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Timepoint [34]
0
0
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years
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Secondary outcome [35]
0
0
Phase 1: Duration of Response (DOR) Per irRC
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Assessment method [35]
0
0
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
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Timepoint [35]
0
0
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years
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Secondary outcome [36]
0
0
Phase 2: Duration of Response (DOR) Per RECIST 1.1
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Assessment method [36]
0
0
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
DOR is reported by tumor type.
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Timepoint [36]
0
0
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years
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Secondary outcome [37]
0
0
Phase 2: Duration of Response (DOR) Per irRC
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Assessment method [37]
0
0
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
DOR is reported by tumor type.
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Timepoint [37]
0
0
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
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Secondary outcome [38]
0
0
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
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Assessment method [38]
0
0
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
PFS is reported for ROW and Japanese patients.
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Timepoint [38]
0
0
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
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Secondary outcome [39]
0
0
Phase 1: Progression-free Survival (PFS) Per irRC
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Assessment method [39]
0
0
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
PFS is reported for ROW and Japanese patients.
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Timepoint [39]
0
0
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
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Secondary outcome [40]
0
0
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
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Assessment method [40]
0
0
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
PFS is reported by tumor type.
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Timepoint [40]
0
0
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
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Secondary outcome [41]
0
0
Phase 2: Progression-free Survival (PFS) Per irRC
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Assessment method [41]
0
0
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
PFS is reported by tumor type.
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Timepoint [41]
0
0
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
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Eligibility
Key inclusion criteria
Phase I part:
- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
Phase II part:
* Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups:
* Group 1: NSCLC
* Group 2: Melanoma
* Group 3: Renal cancer
* Group 4: Mesothelioma
* Group 5: TNBC
* Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
* Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy.
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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
* History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
* Active, known or suspected autoimmune disease
* Active infection requiring systemic antibiotic therapy
* HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency
* Patients receiving systemic treatment with any immunosuppressive medication
* Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment
* Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.
* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks
* History of drug-induced pneumonitis or current pneumonitis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
17/06/2015
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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
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Actual
31/12/2020
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Sample size
Target
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Accrual to date
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Final
490
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
Novartis Investigative Site - Westmead
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Recruitment hospital [2]
0
0
Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
0
0
2145 - Westmead
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Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
New York
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Country [2]
0
0
United States of America
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State/province [2]
0
0
North Carolina
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0
0
United States of America
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State/province [3]
0
0
Texas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Utah
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Leuven
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0
0
Canada
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State/province [6]
0
0
Alberta
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0
0
Canada
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State/province [7]
0
0
Ontario
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Country [8]
0
0
France
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State/province [8]
0
0
Lyon Cedex
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Country [9]
0
0
France
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State/province [9]
0
0
Saint-Herblain Cédex
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Country [10]
0
0
Germany
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State/province [10]
0
0
Heidelberg
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Country [11]
0
0
Germany
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State/province [11]
0
0
Wuerzburg
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Country [12]
0
0
Hong Kong
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State/province [12]
0
0
Hong Kong
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Country [13]
0
0
Italy
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State/province [13]
0
0
MI
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Country [14]
0
0
Italy
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State/province [14]
0
0
MO
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Country [15]
0
0
Japan
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State/province [15]
0
0
Fukuoka
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Country [16]
0
0
Singapore
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State/province [16]
0
0
Singapore
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Country [17]
0
0
Spain
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State/province [17]
0
0
Catalunya
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Country [18]
0
0
Spain
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State/province [18]
0
0
Madrid
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Country [19]
0
0
Taiwan
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State/province [19]
0
0
Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.
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Trial website
https://clinicaltrials.gov/study/NCT02460224
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Trial related presentations / publications
Schoffski P, Tan DSW, Martin M, Ochoa-de-Olza M, Sarantopoulos J, Carvajal RD, Kyi C, Esaki T, Prawira A, Akerley W, De Braud F, Hui R, Zhang T, Soo RA, Maur M, Weickhardt A, Krauss J, Deschler-Baier B, Lau A, Samant TS, Longmire T, Chowdhury NR, Sabatos-Peyton CA, Patel N, Ramesh R, Hu T, Carion A, Gusenleitner D, Yerramilli-Rao P, Askoxylakis V, Kwak EL, Hong DS. Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) +/- anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies. J Immunother Cancer. 2022 Feb;10(2):e003776. doi: 10.1136/jitc-2021-003776.
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Public notes
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Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
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Address
0
0
Novartis Pharmaceuticals
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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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)?
Undecided
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No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT02460224/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT02460224/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02460224