The purpose of this study is to evaluate the objective response, safety, and tolerability of pembrolizumab in Japanese participants who have refractory primary mediastinal large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Pembrolizumab 200 mg by intravenous (IV) infusion, given on day 1 of each 3-week cycle.
Nagoya University Hospital ( Site 0002)
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital ( Site 0006)
Sapporo, Hokkaido, Japan
Kindai University Hospital ( Site 0001)
Sayama, Osaka, Japan
Objective Response Rate (ORR) Using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma as Assessed by Independent Central Review
ORR is defined as the percentage of participants with response (complete response, CR or partial response, PR) according to the International Working Group (IWG) Response Assessment Criteria for Malignant Lymphoma per Cheson 2007. CR is the disappearance of all evidence of disease. PR is ≥ 50% decrease in the sum of product diameters (SPD) of the six largest dominant nodes or nodal masses, ≥ 50% decrease in SPD of splenic and hepatic nodules, no increase in the size of the other nodes, liver, or spleen plus no measurable disease in other organs and no new sites of disease. Per protocol, the percentage of participants who experienced a CR or PR as assessed by independent central review were reported.
Time frame: Up to approximately 24 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event (AE) was 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, which occurs during the course of the study. Per protocol, the number of participants who experienced at least one AE were reported.
Time frame: Up to approximately 27 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE was 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, which occurs during the course of the study. Per protocol, the number of participants who discontinued study treatment due to an AE were reported.
Time frame: Up to approximately 24 months
Objective Response Rate (ORR) Using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma as Assessed by Investigator
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National Hospital Organization Disaster Medical Center ( Site 0007)
Tachikawa, Tokyo, Japan
Kyushu University Hospital ( Site 0008)
Fukuoka, Japan
Okayama University Hospital ( Site 0004)
Okayama, Japan
National Cancer Center Hospital ( Site 0005)
Tokyo, Japan
Tokyo Metropolitan Komagome Hospital ( Site 0009)
Tokyo, Japan
Yamagata University Hospital ( Site 0003)
Yamagata, Japan
ORR is defined as the percentage of participants with response (complete response, CR or partial response, PR) according to the International Working Group (IWG) Response Assessment Criteria for Malignant Lymphoma per Cheson 2007. CR is the disappearance of all evidence of disease. PR is ≥ 50% decrease in the sum of product diameters (SPD) of the six largest dominant nodes or nodal masses, ≥ 50% decrease in SPD of splenic and hepatic nodules, no increase in the size of the other nodes, liver, or spleen plus no measurable disease in other organs and no new sites of disease. Per protocol, the percentage of participants who experienced a CR or PR as assessed by investigator review were reported.
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) Using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma as Assessed by Independent Central Review
The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or stable disease (SD) response prior to PD according to the International Working Group (IWG) Response Assessment Criteria for Malignant Lymphoma per Cheson 2007. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites of disease. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Per protocol, the percentage of participants who experienced a CR, a PR, or SD as assessed by independent central review were reported.
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) Using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma as Assessed by Investigator
The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or stable disease (SD) response prior to PD according to the International Working Group (IWG) Response Assessment Criteria for Malignant Lymphoma per Cheson 2007. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites of disease. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Per protocol, the percentage of participants who experienced a CR, a PR, or SD as assessed by investigator review were reported.
Time frame: Up to approximately 24 months