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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-G21 | Other Identifier | MSD | |
| jRCT2041250120 | Registry Identifier | jRCT (Japan Registry of Clinical Trials) |
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Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Pembrolizumab in Pediatric Participants with Solid Tumors or Lymphomas | Experimental | Pediatric participants with solid tumors or lymphomas receive 2 mg/kg pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 17 or 35 cycles. |
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| Arm 2: Pembrolizumab in Adult Participants with Merkel Cell Carcinoma (MCC) | Experimental | Adult participants with MCC receive 400 mg pembrolizumab via IV infusion on Day 1 of each 42 day (6 week) cycle, for up to 18 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | 25 mg/mL solution for intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Arm 1: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who experience an AE will be reported. | Up to approximately 28 months |
| Arm 1: Number of Participants Who Discontinue Study Treatment Due To an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who discontinue study treatment due to an AE will be reported. | Up to approximately 25 months |
| Arm 1: Area Under the Concentration-Time Curve (AUC) of Pembrolizumab | AUC is defined as the area under the concentration-time curve of pembrolizumab. Blood samples will be collected at specified intervals for the determination of AUC. AUC in participants with solid tumors or lymphomas will be reported. | Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days) |
| Arm 1: Maximum Concentration (Cmax) of Pembrolizumab | Cmax is defined as the maximum concentration of pembrolizumab reached. Blood samples will be collected at pre-specified intervals for the determination of Cmax. Cmax in participants with solid tumors or lymphomas will be reported. | Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Arm 1: ORR per RECIST 1.1 by Investigator Assessment | ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator assessment. ORR in participants with solid tumors will be reported. | Up to approximately 46 months |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Arm 1:
For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL)
For participants with completely resected melanoma:
For participants with locally advanced or metastatic melanoma:
For participants with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) solid tumors:
For participants with tumor mutational burden-high (TMB-H) solid tumors:
For participants with MCC:
Arm 2:
For participants with MCC:
Arm 1 & Arm 2:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital ( Site 0003) | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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No blinding for Arm 1. Outcomes assessor blinded for Arm 2.
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| Arm 1: Minimum Plasma Concentration (Cmin) of Pembrolizumab | Cmin is defined as the minimum concentration of pembrolizumab observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples will be collected at pre-specified timepoints to determine Cmin. Cmin in participants with solid tumors or lymphomas will be reported. | Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days) |
| Arm 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) | ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR in participants with Merkel cell carcinoma will be reported. | Up to approximately 37 months |
| Arm 1: ORR per Lugano Classification by Investigator Assessment | ORR is defined as complete response (CR: all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or partial response (PR: ≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression), per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014). ORR in participants with lymphomas as assessed by investigator will be reported. | Up to approximately 46 months |
| Arm 1: Duration of Response (DOR) per RECIST 1.1 by Investigator Assessment | For participants who demonstrate a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported. | Up to approximately 46 months |
| Arm 1: DOR per Lugano Classification by Investigator Assessment | For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR (all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or PR (≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression) per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014) until progressive disease (PD: based on the progression of any single lesion and other certain requirements) or death due to any cause, whichever occurs first. DOR in participants with lymphomas as assessed by investigator will be reported. | Up to approximately 46 months |
| Arm 1: Disease Control (DCR) per RECIST 1.1 by Investigator Assessment | DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). DCR per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported. | Up to approximately 46 months |
| Arm 1: DCR per Lugano Classification by Investigator Assessment | DCR is defined as confirmed CR (all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter), PR (≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression), or stable disease (SD: Target lesions do not meet the criteria for CR or PR and no individual lesion meets the criteria for progression) per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014). DCR in participants with lymphomas as assessed by investigator will be reported. | Up to approximately 46 months |
| Arm 1: Progression-free Survival (PFS) per RECIST 1.1 by Investigator Assessment | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported. | Up to approximately 46 months |
| Arm 1: PFS per Lugano Classification by Investigator Assesment | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014) by investigator. PD per Lugano classification is defined as based on the progression of any single lesion and other certain requirements. PFS in participants with solid tumors will be reported. | Up to approximately 46 months |
| Arm 1: Relapse-free Survival (RFS) per RECIST 1.1 by Investigator Assessment | RFS is defined only for adjuvant melanoma participants as the time from first dose to recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first. New incident cases of melanoma and second cancer diagnoses are not counted as events for recurrence-free survival. RFS in participants with solid tumors or lymphomas will be reported. | Up to approximately 46 months |
| Arm 1: Distant Metastasis-free Survival (DMFS) per RECIST 1.1 by Investigator Assessment | DMFS is defined only for adjuvant melanoma participants as the time from first dosing to the first diagnosis of a distant metastasis per RECIST 1.1 by investigator assessment or death (due to any cause), whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS in participants with solid tumors or lymphomas will be reported. | Up to approximately 46 months |
| Arm 1: Overall Survival (OS) | OS is defined as the time from the first dose of study intervention to death due to any cause. OS in participants with solid tumors or lymphomas will be reported. | Up to approximately 46 months |
| Arm 1: Number of Participants with Anti-Drug Antibodies (ADAs) Against Pembrolizumab | Blood samples will be collected at multiple time points to determine the ADA response to pembrolizumab. The number of participants with ADA for pembrolizumab in participants with solid tumors or lymphomas will be reported. | Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles (a cycle is 21 days) |
| Arm 2: ORR per RECIST 1.1 by Investigator Assessment | ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator assessment. ORR in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: DOR per RECIST 1.1 by BICR | For participants who demonstrate a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: DOR per RECIST 1.1 by Investigator Assessment | For participants who demonstrate a confirmed CR: disappearance of all target lesions or PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR by investigator assessment in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: DCR per RECIST 1.1 by BICR | DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). DCR per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported. | Up to approximate ly 46 months |
| Arm 2: DCR per RECIST 1.1 by Investigator Assessment | DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD). DCR per RECIST 1.1 by investigator assessment in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: PFS per RECIST 1.1 by BICR | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: PFS per RECIST 1.1 by Investigator Assesment | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by investigator assessment in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: OS | OS is defined as the time from the first dose of study intervention to death due to any cause. OS in participants with Merkel cell carcinoma will be reported. | Up to approximately 46 months |
| Arm 2: Cmax of Pembrolizumab | Cmax is defined as the maximum concentration of pembrolizumab reached. Blood samples will be collected at pre-specified intervals for the determination of Cmax. Cmax in participants with Merkel cell carcinoma will be reported. | Predose at Cycles 1-4, and every 2 cycles thereafter up to 18 cycles; postdose at Cycle 1 and Cycle 3 (a cycle is 42 days) |
| Arm 2: Cmin of Pembrolizumab | Cmin is defined as the minimum concentration of pembrolizumab observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples will be collected at pre-specified timepoints to determine Cmin. Cmin in participants with Merkel cell carcinoma will be reported. | Predose at Cycles 1-4, and every 2 cycles thereafter up to 18 cycles; postdose at Cycle 1 and Cycle 3 (a cycle is 42 days) |
| Arm 2: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with Merkel cell carcinoma who experience an AE will be reported. | Up to approximately 28 months |
| Arm 2: Number of Participants Who Discontinue Study Treatment Due To an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with Merkel cell carcinoma who discontinue study treatment due to an AE will be reported. | Up to approximately 25 months |
| Nagoya City University Hospital ( Site 0007) | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
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| Sapporo Hokuyu Hospital ( Site 0005) | Recruiting | Sapporo | Hokkaido | 003-0006 | Japan |
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| Hyogo Prefectural Kobe Children's Hospital ( Site 0006) | Recruiting | Kobe | Hyōgo | 650-0047 | Japan |
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| National Cancer Center Hospital ( Site 0002) | Recruiting | Chūō | Tokyo | 104-0045 | Japan |
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| National Hospital Organization Kyushu Cancer Center ( Site 0001) | Recruiting | Fukuoka | 811-1395 | Japan |
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| University Hospital,Kyoto Prefectural University of Medicine ( Site 0004) | Recruiting | Kyoto | 602-8566 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015266 | Carcinoma, Merkel Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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