The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Pembrolizumab, 400 mg, Q6W, intravenous (IV) infusion.
Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator
ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by investigator is presented.
Time frame: Up to approximately 30 months
ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by BICR is presented.
Time frame: Up to approximately 30 months
Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator
For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants will be evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by investigator is presented among participants who demonstrated CR or PR.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
Torrance, California, United States
Tulane Medical Center ( Site 0110)
New Orleans, Louisiana, United States
Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)
Annapolis, Maryland, United States
Hospital Erasto Gaertner ( Site 1703)
Curitiba, Paraná, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701)
Barretos, São Paulo, Brazil
Cross Cancer Institute ( Site 0207)
Edmonton, Alberta, Canada
Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)
Prague, Praha 10, Czechia
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)
Hradec Králové, Czechia
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401)
Dijon, Cote-d Or, France
...and 17 more locations
Time frame: Up to approximately 54 months
DOR Per Lugano Classification as Assessed by BICR
For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants will be evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by BICR is presented among participants who demonstrated CR or PR.
Time frame: Up to approximately 54 months
Area Under the Curve (AUC) Early Cycle of Pembrolizumab
AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 1 (early cycle). A cycle was 6 weeks.
Time frame: Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks)
Area Under the Curve (AUC) Steady State of Pembrolizumab
AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 4 (steady state). A cycle was 6 weeks.
Time frame: Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks)
Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab
Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 1 (early cycle).
Time frame: Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks)
Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab
Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 4 (steady state).
Time frame: Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab
Ctrough is defined as the lowest serum drug concentration. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 1 (early cycle).
Time frame: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab
Ctrough is defined as the lowest serum drug concentration. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 4 (steady state).
Time frame: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks)
Antidrug Antibody Levels (ADA) for Pembrolizumab
Blood samples were collected and assayed for anti-pembrolizumab antibodies presence using a validated electrochemiluminescence immunoassay. Negative ADA refers to all pre-treatment and postdose samples negative in the assay for antibodies against pembrolizumab and the concentration of pembrolizumab in the last postdose sample below the drug tolerance level. Treatment emergent positive was defined as pre-treatment sample negative and at least one postdose sample positive in the assay or pre-treatment and postdose sample positive with an increase in titer (≥2 fold of baseline). Non-treatment emergent positive was defined as pre-treatment sample positive and postdose sample negative or pre-treatment and postdose sample positive with a postdose titer \<2 fold of baseline. Neutralizing positive was defined as at least 1 of the ADA positive samples test positive in the neutralizing assay.
Time frame: Predose 0-4 hours on Cycle1 Day1, Cycle2 Day1, Cycle4 Day1, Cycle5 Day1, Cycle7 Day1, Cycle9 Day1, Cycle13 Day1, Cycle17 Day1 and end of infusion on Cycle1 Day1, Cycle4 Day1 and anytime on Cycle1 Day22 and Cycle4 Day22 (cycle length = 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE)
An 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.
Time frame: Up to approximately 54 months
Number of Participants Who Discontinued Study Treatment Due to AE
An 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.
Time frame: Up to approximately 54 months