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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/NCT02332668
Registration number
NCT02332668
Ethics application status
Date submitted
6/01/2015
Date registered
7/01/2015
Date last updated
11/01/2024
Titles & IDs
Public title
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
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Scientific title
A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)
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Secondary ID [1]
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0
MK-3475-051
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Secondary ID [2]
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0
3475-051
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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:
Melanoma
0
0
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Lymphoma
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0
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Solid Tumor
0
0
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Classical Hodgkin Lymphoma
0
0
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Microsatellite-instability-high Solid Tumor
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
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0
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Malignant melanoma
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Experimental: Melanoma - Participants aged 6 months to <18 years with melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W). Enrollment of participants aged 6 months to <12 years with melanoma was closed with Amendment 8. Enrollment of participants aged =12 years to =18 years with melanoma continues.
Experimental: Solid Tumors and Other Lymphomas - Participants aged 6 months to <18 years with solid tumors and other lymphomas receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Initial enrollment limited to programmed death-ligand 1 (PD-L1)-positive participants. PD-L1-negative participants may enroll if responses are observed. Enrollment of participants with solid tumors and other lymphomas was closed with Amendment 8.
Experimental: rrcHL - Participants aged 3 years to <18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Experimental: MSI-H - Participants aged 6 months to <18 years with microsatellite-instability-high (MSI-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Experimental: TMB-H - Participants aged 6 months to <18 years with tumor-mutational burden-high =10 mutation/Mb (TMB-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Experimental: Adjuvant Melanoma - Participants aged 12 years to <18 years with resected high-risk Stage IIB, IIC, III, or IV melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W).
Other interventions: Pembrolizumab
IV infusion
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Intervention code [1]
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0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately)
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Assessment method [1]
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The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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ORR by RECIST 1.1 per Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately)
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Assessment method [2]
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The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [2]
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Up to 2 years
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Primary outcome [3]
0
0
ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per BICR Assessment for rrcHL Cohort
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Assessment method [3]
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The ORR is assessed by blinded independent central review utilizing the International Working Group [IWG] response assessment criteria per Cheson 2007 by BICR. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.
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Timepoint [3]
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0
Up to approximately 2 years
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Primary outcome [4]
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Number of Participants with Dose-Limiting Toxicities (DLTs)
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Assessment method [4]
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Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose.
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Timepoint [4]
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Cycle 1 (Up to 21 days)
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Primary outcome [5]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [5]
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An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [5]
0
0
Up to 27 months
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Primary outcome [6]
0
0
Number of Participants Discontinuing Study Drug Due to AEs
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Assessment method [6]
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An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [6]
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0
Up to 2 years
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Secondary outcome [1]
0
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ORR by IWG Response Criteria (Cheson, 2007) per Site Assessment (rrcHL Cohort)
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Assessment method [1]
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The ORR is assessed by blinded independent central review utilizing the International Working Group [IWG] response assessment criteria per Cheson 2007 by site assessment. The ORR is defined as the percentage of participants who had a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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DOR per RECIST 1.1 by Site Assessment (Advanced Melanoma, Solid Tumors and Other Lymphoma, Each Disease Indication Is Evaluated Separately)
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Assessment method [2]
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The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [2]
0
0
Up to approximately 2 years
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Secondary outcome [3]
0
0
DOR per RECIST 1.1 by Site Assessment (MSI-H and TMBH, Each Cohort Is Evaluated Separately)
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Assessment method [3]
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0
The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [3]
0
0
Up to approximately 2 years
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Secondary outcome [4]
0
0
DOR per IWG 2007 (Cheson, 2007) Response by BICR Assessment (rrcHL Cohort)
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Assessment method [4]
0
0
The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [4]
0
0
Up to approximately 2 years
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Secondary outcome [5]
0
0
DOR per IWG 2007 (Cheson, 2007) Response by Site Assessment (rrcHL Cohort)
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Assessment method [5]
0
0
The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [5]
0
0
Up to approximately 2 years
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Secondary outcome [6]
0
0
DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
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Assessment method [6]
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The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [6]
0
0
Up to approximately 2 years
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Secondary outcome [7]
0
0
DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (MSI-H and TMB-H, Each Cohort Is Evaluated Separately)
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Assessment method [7]
0
0
The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
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Timepoint [7]
0
0
Up to approximately 2 years
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Secondary outcome [8]
0
0
Progression-free Survival (PFS) Using RECIST 1.1 Criteria by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
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Assessment method [8]
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Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [8]
0
0
Up to approximately 2 years
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Secondary outcome [9]
0
0
PFS using RECIST 1.1 Criteria by Site Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately)
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Assessment method [9]
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0
Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [9]
0
0
Up to approximately 2 years
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Secondary outcome [10]
0
0
PFS using IWG 2007 Criteria (Chesson 2007) by BICR Assessment (rrcHL Cohort)
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Assessment method [10]
0
0
Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by BICR assessment (rrcHL Cohort). Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [10]
0
0
Up to approximately 2 years
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Secondary outcome [11]
0
0
PFS using IWG 2007 Criteria (Chesson, 2007) by Site Assessment (rrcHL Cohort)
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Assessment method [11]
0
0
Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [11]
0
0
Up to approximately 2 years
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Secondary outcome [12]
0
0
PFS Using irRECIST Criteria by Site Assessment
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Assessment method [12]
0
0
Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using irRECIST criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [12]
0
0
Up to approximately 2 years
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Secondary outcome [13]
0
0
Disease Control Rate by RECIST 1.1 Using Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
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Assessment method [13]
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Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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Timepoint [13]
0
0
Up to approximately 2 years
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Secondary outcome [14]
0
0
Disease Control Rate by RECIST 1.1 Using Site Assessment (MSIH and TMB-H, Each Cohort Evaluated Separately)
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Assessment method [14]
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Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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Timepoint [14]
0
0
Up to approximately 2 years
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Secondary outcome [15]
0
0
Disease Control Rate by irRECIST Using Site Assessment (Solid Tumors and Other Lymphomas, Each Disease Indication Evaluated Separately)
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Assessment method [15]
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Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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Timepoint [15]
0
0
Up to approximately 2 years
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Secondary outcome [16]
0
0
Overall Survival
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Assessment method [16]
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0
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. Median overall survival will be calculated from the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [16]
0
0
Up to approximately 2 years
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Secondary outcome [17]
0
0
Objective irRECIST Response Rate by Site Assessment (Each Disease Indication Evaluated Separately)
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Assessment method [17]
0
0
The ORR is assessed by irRECIST per site assessment.
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Timepoint [17]
0
0
Up to approximately 2 years
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Secondary outcome [18]
0
0
Area Under the Concentration Curve (AUC) for Pembrolizumab
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Assessment method [18]
0
0
The AUC of pembrolizumab when administered as monotherapy will be determined.
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Timepoint [18]
0
0
Predose Cycles 1, 2, 4, 8 and every 4 cycles thereafter, and within 30 minutes post infusion at Cycles 1 and 8. Additional single pharmacokinetic samples obtained in Cycle 1 between 72 to 168 hours post-dose, and Cycle 1 at 336 hours post-dose
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Eligibility
Key inclusion criteria
- Between 6 months and <18 years of age on day of signing informed consent is
documented.
- Histologically- or cytologically-documented, locally-advanced, or metastatic solid
malignancy or lymphoma that is incurable and has failed prior standard therapy, or for
which no standard therapy exists, or for which no standard therapy is considered
appropriate
- Any number of prior treatment regimens
- Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue
sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor
lesion not previously irradiated
- Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or
lymphoma
- Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e.,
measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL
participants)
- Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive
evaluable disease may be enrolled
- Lansky Play Scale =50 for participants from 6 months up to and including 16 years of
age; or Karnofsky score =50 for participants >16 years of age
- Adequate organ function
- Female participants of childbearing potential should have a negative urine or serum
pregnancy test within 72 hours before the first dose of study medication
- Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who
is abstinent from heterosexual intercourse or using contraception during the
intervention period and for at least 120 days after the last dose of study
intervention
- Contraceptive use by men should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies.
- Demonstrate adequate organ function.
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Minimum age
6
Months
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Maximum age
17
Years
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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
- Currently participating and receiving study therapy in, or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the date of allocation/randomization
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the date of
allocation/randomization
- Prior systemic anti-cancer therapy including investigational agent within 2 weeks
prior to study Day 1 or not recovered from adverse events due to a previously
administered agent
- Prior radiotherapy within 2 weeks of start of study treatment
- Known additional malignancy that is progressing or requires active treatment with the
exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or
carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially
curative therapy, or in situ cervical cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Tumor(s) involving the brain stem
- Severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
- Active autoimmune disease that has required systemic treatment in past 2 years;
replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) is acceptable
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.
- Active infection requiring systemic therapy
- Pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial through 120 days after the last dose of study
medication
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1
(anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or
inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4],
OX-40, CD137)
- Human immunodeficiency virus (HIV)
- Hepatitis B or C
- Known history of active tuberculosis (TB; Bacillus tuberculosis)
- Received a live vaccine within 30 days of planned start of study medication
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic
stem cell transplantation within the last 5 years. (Participants who have had an
allogeneic hematopoietic transplant >5 years ago are eligible as long as there are no
symptoms of Graft Versus Host Disease [GVHD].)
- History or current evidence of any condition, therapy, or laboratory abnormality, or
known severe hypersensitivity to any component or analog of the trial treatment, that
might confound the results of the trial, or interfere with the participant's
participation for the full duration of the study
- Known psychiatric or substance abuse disorders that would interfere with the
requirements of the study
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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
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
18/03/2015
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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
25/10/2027
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Actual
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Sample size
Target
370
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
MSD Australia - North Ryde
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Recruitment postcode(s) [1]
0
0
- North Ryde
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Colorado
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Indiana
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Tennessee
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Washington
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Country [9]
0
0
Brazil
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State/province [9]
0
0
Sao Paulo
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Country [10]
0
0
France
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State/province [10]
0
0
Paris
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Country [11]
0
0
Germany
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State/province [11]
0
0
Haar
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Country [12]
0
0
Israel
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State/province [12]
0
0
Hod Hasharon
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Country [13]
0
0
Italy
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State/province [13]
0
0
Rome
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Country [14]
0
0
Korea, Republic of
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State/province [14]
0
0
Seoul
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Country [15]
0
0
Netherlands
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State/province [15]
0
0
Haarlem
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Country [16]
0
0
Sweden
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State/province [16]
0
0
Stockholm
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Country [17]
0
0
United Kingdom
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State/province [17]
0
0
Hoddesdon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of
the following types of cancer:
- advanced melanoma (6 months to <18 years of age),
- advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant
solid tumor or other lymphoma (6 months to <18 years of age),
- relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age),
or
- advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6
months to <18 years of age), or
- advanced relapsed or refractory tumor-mutational burden-high =10 mutation/Mb (TMB-H)
solid tumors (6 months to <18 years of age), or
- with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in
children 12 years to <18 years of age
Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm
the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will
further evaluate the safety and efficacy at the pediatric RP2D.
The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab
to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory
solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL,
will result in an Objective Response Rate (ORR) greater than 10% for at least one of these
types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.
With Amendment 8, enrollment of participants with solid tumors and of participants aged 6
months to <12 years with melanoma were closed. Enrollment of participants aged =12 years to
=18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid
tumors also continues.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02332668
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Public notes
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Contacts
Principal investigator
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Merck Sharp & Dohme LLC
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1-888-577-8839
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02332668
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