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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-B68 | Other Identifier | MSD | |
| 2024-510979-38-00 | Registry Identifier | EU CT | |
| U1111-1302-8634 | Registry Identifier | UTN | |
| 2020-005609-20 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | Pembrolizumab, 400 mg, Q6W, intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
PMBCL-Specific Disease Characteristics:
OR
- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
Note: Participants should not need urgent cytoreductive therapy.
cHL-Specific Disease Characteristics:
OR
Have received at least ≥1 line of prior multiagent therapy with/without brentuximab vedotin (excluding radiation) or auto-SCT for cHL and have failed to respond to or relapsed after their last line of treatment.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of child bearing potential (WOCBP). OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), for at least 120 days after the last dose of study intervention.
Submit an evaluable core lymph node biopsy for biomarker analysis from an archival (>60 days) or newly obtained (within 30 days) core or incisional biopsy at Screening which was not previously irradiated. Note: If no archival tissue is available, 2 new fresh core needle samples are required.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Life expectancy >3 months.
Adequate organ function.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site | Torrance | California | 90502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | Participants with rrcHL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. |
| FG001 | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 |
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| 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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. | Up to approximately 54 months |
| Tulane Medical Center ( Site 0110) | New Orleans | Louisiana | 70112 | United States |
| Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125) | Annapolis | Maryland | 21401 | United States |
| Hospital Erasto Gaertner ( Site 1703) | Curitiba | Paraná | 81520-060 | Brazil |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701) | Barretos | São Paulo | 14784-400 | Brazil |
| Cross Cancer Institute ( Site 0207) | Edmonton | Alberta | T6G 1Z2 | Canada |
| Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302) | Brno | Brno-mesto | 625 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303) | Prague | Praha 10 | 100 34 | Czechia |
| Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304) | Hradec Králové | 500 05 | Czechia |
| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401) | Dijon | Cote-d Or | 21000 | France |
| Gustave Roussy ( Site 0402) | Villejuif | ÃŽle-de-France Region | 94800 | France |
| Fondazione IRCCS Policlinico San Matteo ( Site 0509) | Pavia | Lombardy | 27100 | Italy |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507) | Palermo | Sicily | 90146 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503) | Naples | 80131 | Italy |
| Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S | Poznan | Greater Poland Voivodeship | 61-848 | Poland |
| Pratia MCM Krakow ( Site 0064) | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063) | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| The National Medico-Surgical Center N.I. Pirogov ( Site 0801) | Moscow | Moscow | 105203 | Russia |
| Moscow City Clinical Hospital S.P. Botkin ( Site 0803) | Moscow | Moscow | 125284 | Russia |
| Almazov National Medical Research Centre ( Site 0807) | Saint Petersburg | Sankt-Peterburg | 197341 | Russia |
| Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902) | Centurion | Gauteng | 0044 | South Africa |
| Wits Clinical Research ( Site 0904) | Johannesburg | Gauteng | 1864 | South Africa |
| Groote Schuur Hospital ( Site 0906) | Cape Town | Western Cape | 7925 | South Africa |
| Ege University Medicine of Faculty ( Site 1105) | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Ankara University Department of Hematology, Clinical Research Unit ( Site 1101) | Ankara | 06100 | Turkey (Türkiye) |
| CNPE Regional Center of Oncology ( Site 1305) | Kharkiv | Kharkiv Oblast | 61070 | Ukraine |
| National Cancer Institute ( Site 1303) | Kyiv | Kyivska Oblast | 03022 | Ukraine |
Participants with rrPMBCL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | Participants with rrcHL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. |
| BG001 | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | Participants with rrPMBCL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 30 months |
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| Secondary | 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. | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 30 months |
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| Secondary | 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. | Not Posted | Dec 2026 | Up to approximately 54 months | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Dec 2026 | Up to approximately 54 months | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis population consisted of all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | day*µg/mL | Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks) |
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| Secondary | 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. | The analysis population consisted of all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | day*µg/mL | Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks) |
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| Secondary | 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). | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 1 end of infusion concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | μg/ml | Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks) |
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| Secondary | 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). | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 4 end of infusion concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | μg/ml | Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks) |
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| Secondary | 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). | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 1 trough concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants with rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | μg/ml | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks) |
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| Secondary | 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). | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 4 trough concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants with rrcHL or rrPMBCL. | Posted | Geometric Mean | 95% Confidence Interval | μg/ml | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks) |
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| Secondary | 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. | The analysis population consisted of all participants who received ≥1 dose of study treatment and had a negative ADA or positive ADA status. The analysis was pre-specified to be a pooled analysis of all participants with rrcHL or rrPMBCL. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Not Posted | Dec 2026 | Up to approximately 54 months | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Dec 2026 | Up to approximately 54 months | Participants |
Up to approximately 30 months
The analysis population for AEs included all participants who received ≥1 dose of study treatment. MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | Participants with rrcHL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. | 9 | 60 | 5 | 60 | 38 | 60 |
| EG001 | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | Participants with rrPMBCL received pembrolizumab 400 mg as an intravenous (IV) infusion on Day 1, then every six weeks (Q6W) up to 18 doses. | 3 | 6 | 0 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastric stenosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | clinicaltrialsdisclosure@msd.com |
| Dec 5, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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