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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4621-002 | Other Identifier | Merck Protocol Number | |
| 2018-000845-37 | EudraCT Number |
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Business Reasons
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The purpose of this study is to evaluate safety and tolerability, pharmacokinetics (PK), and preliminary antitumor activity of intratumoral (IT) / intralesional injections of MK-4621 delivered via the JetPEI™ in vivo linear polyethylenimine nucleic acid delivery system as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4621 Monotherapy (Arm 1) | Experimental | Participants receive MK-4621 once a week (Q1W) during each 21-day cycle for a maximum duration of 6 cycles. |
|
| MK-4621 + Pembrolizumab (Arm 2) | Experimental | Participants receive escalating doses of MK-4621 Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants may continue on treatment with pembrolizumab after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. Dose escalation of MK-4621 will be based on safety and tolerability. |
|
| Intrahepatic MK-4621 + Pembrolizumab (Arm 3) | Experimental | Participants receive MK-4621 as monotherapy on Day 1 only of the first 21-day cycle (run-in phase). After the run-in phase, participants receive escalating doses of MK-4621 Q3W in combination with pembrolizumab at a fixed dose 200 mg Q3W for a maximum duration of 5 cycles (Cycles 2-6). Participants may continue on treatment with pembrolizumab for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. Dose escalation of MK-4621 will be based on safety and tolerability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4621 | Biological | MK-4621 is delivered via the JetPEI™ in vivo linear polyethylenimine nucleic acid delivery system as follows: For Arm 1: administered intratumorally Q1W, on Days 1, 8, and 15 of each 21-day cycle. For Arm 2: administered intratumorally Q1W, on Days 1, 8, and 15 of each 21-day cycle according to randomization. For Arm 3: administered intratumorally Q3W, on Day 1 of each 21-day cycle. Range administered will depend upon allocation and be based on emerging safety data. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | The following toxicities during DLT evaluation period were considered DLT, if assessed by investigator to be possibly, probably, or definitely related to treatment: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days or protocol-specified thrombocytopenia; any nonhematologic adverse event (AE) ≥Gr 3 in severity (with exceptions); any Gr 3/Gr 4 nonhematologic laboratory value if clinically significant medical intervention was required to treat the participant, or the abnormality led to hospitalization, or the abnormality persisted for >1 week; or the abnormality resulted in a drug-induced liver injury; febrile neutropenia Gr 3/Gr 4; >2 week delay in initiating Cycle 2 due to treatment-related toxicity; any treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1; missing >2 injections of MK-4621 during Cycle 1, or Gr 5 toxicity. The percentage of participants who experienced DLTs were reported for each arm. | Up to 21 days (Cycle 1) |
| Number of Participants Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant that was temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE was reported for each arm. | Up to approximately 13 months |
| Number of Participants Discontinuing Study Treatment Due to AEs | An AE was defined as any untoward medical occurrence in a participant that was temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE was reported for each arm. | Up to approximately 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) of MK-4621 | AUC is the area under the plot of plasma concentration of drug against time after drug administration and is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. Blood samples were collected at multiple time points (pre-dose and post-dose) during the study to assess the AUC of MK-4621. | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
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Inclusion Criteria:
Arms 1 and 2: have 3 lesions defined as follows: 1) at least 1 cutaneous or subcutaneous lesion that is amenable to injection and biopsy (lesion 1) that is measurable as defined by RECIST 1.1, 2) at least 1 discrete non-injected, non-biopsied lesion that is measurable as defined by RECIST 1.1 (lesion 2), and 3) at least 1 discrete and/or distant non-injected lesion amenable for biopsy (lesion 3)
Arm 3 only: Has metastatic liver and/or liver lesion involvement that does not exceed one third of the total liver volume in participants to be treated by liver IT injection. Hepatocellular carcinoma participants are excluded from eligibility of intratumoral liver injection. For Arm 3, at least 2 lesions have to be identified as follows: 1) at least 1 liver lesion amenable to image-guided intratumoral injection and biopsy via ultrasound guidance or cross-sectional imaging (CT/MRI) guidance and must be measurable as defined by RECIST 1.1 (lesion 1) and 2) at least 1 other discrete non-injected, non-biopsied lesion that is measurable as defined by RECIST 1.1 (lesion 2)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie ( Site 3303) | Bordeaux | 33076 | France | |||
| CHU La Timone ( Site 3304) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35596791 | Derived | Moreno V, Calvo E, Middleton MR, Barlesi F, Gaudy-Marqueste C, Italiano A, Romano E, Marabelle A, Chartash E, Dobrenkov K, Zhou H, Connors EC, Zhang Y, Wermke M. Treatment with a retinoic acid-inducible gene I (RIG-I) agonist as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: results from two phase 1 studies. Cancer Immunol Immunother. 2022 Dec;71(12):2985-2998. doi: 10.1007/s00262-022-03191-8. Epub 2022 May 21. |
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A total of 30 participants were enrolled to Arm 2 at 3 different dose levels. The study was terminated before enrolment into Arm 1 and Arm 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-4621 Monotherapy (Arm 1) | Participants were to receive MK-4621 monotherapy once a week (Q1W) during each 21-day cycle for a maximum duration of 6 cycles. No participants were enrolled in this arm. |
| FG001 | MK-4621 0.4 mg + Pembrolizumab (Arm 2) |
| 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 | Oct 27, 2020 |
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| Pembrolizumab | Biological | 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle beginning with Cycle 1 (Arm 2) or Cycle 2 (Arm 3). |
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| Minimum Concentration (Cmin) of MK-4621 | Cmin was defined as the minimum or "trough" concentration of MK-4621 observed after its administration and just prior to the administration of a subsequent dose. Blood samples were collected at multiple time points (pre-dose and post-dose) during the study to assess the Cmin of MK-4621. | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
| Maximum Concentration (Cmax) of MK-4621 | Cmax was defined as the maximum or "peak" concentration of MK-4621 observed after its administration. Blood samples were collected at multiple time points (pre-dose and post-dose) to assess the Cmax of MK-4621. | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, ≥30% decrease in the sum of diameters of target lesions) as assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based upon investigator assessment. ORR was reported for each treatment arm. | Up to approximately 22 months (through data cut-off of 02-Mar-2021) |
| Marseille |
| 13005 |
| France |
| Institut Curie ( Site 3302) | Paris | 75005 | France |
| Institut Gustave Roussy ( Site 3301) | Villejuif | 94800 | France |
| Charite Campus Benjamin Franklin ( Site 4903) | Berlin | 10117 | Germany |
| Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 4901) | Dresden | 01307 | Germany |
| Hospital Universitario Fundacion Jimenez Diaz ( Site 3401) | Madrid | 28040 | Spain |
| Centro Integral Oncologico Clara Campal START Madrid ( Site 3402) | Madrid | 28050 | Spain |
| Oxford University Hospital NHS Foundation Trust ( Site 4401) | Oxford | OX3 7LE | United Kingdom |
Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| FG002 | MK-4621 0.6 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| FG003 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| FG004 | Intrahepatic MK-4621 + Pembrolizumab (Arm 3) | Participants were to receive MK-4621 monotherapy via intrahepatic administration on Day 1 only of the first 21-day cycle (run-in phase). After the run-in phase, participants were to receive MK-4621 Q3W in combination with pembrolizumab 200 mg Q3W for a maximum duration of 5 cycles (Cycles 2-6). No participants were enrolled in this arm. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-4621 0.4 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| BG001 | MK-4621 0.6 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| BG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
| BG003 | 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 | Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | The following toxicities during DLT evaluation period were considered DLT, if assessed by investigator to be possibly, probably, or definitely related to treatment: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days or protocol-specified thrombocytopenia; any nonhematologic adverse event (AE) ≥Gr 3 in severity (with exceptions); any Gr 3/Gr 4 nonhematologic laboratory value if clinically significant medical intervention was required to treat the participant, or the abnormality led to hospitalization, or the abnormality persisted for >1 week; or the abnormality resulted in a drug-induced liver injury; febrile neutropenia Gr 3/Gr 4; >2 week delay in initiating Cycle 2 due to treatment-related toxicity; any treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1; missing >2 injections of MK-4621 during Cycle 1, or Gr 5 toxicity. The percentage of participants who experienced DLTs were reported for each arm. | The DLT-evaluable population included all randomized participants who received at least 1 dose of study treatment and who met the criteria for DLT evaluability (e.g. completed the DLT evaluation period without a DLT or experienced a DLT in the DLT evaluation period). | Posted | Number | 80% Confidence Interval | Percentage of Participants | Up to 21 days (Cycle 1) |
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| Primary | Number of Participants Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant that was temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE was reported for each arm. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 13 months |
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| Primary | Number of Participants Discontinuing Study Treatment Due to AEs | An AE was defined as any untoward medical occurrence in a participant that was temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE was reported for each arm. | All randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 13 months |
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| Secondary | Area Under the Concentration-time Curve (AUC) of MK-4621 | AUC is the area under the plot of plasma concentration of drug against time after drug administration and is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. Blood samples were collected at multiple time points (pre-dose and post-dose) during the study to assess the AUC of MK-4621. | The Per Protocol population included all randomized participants who received at least 1 dose of study treatment, who complied with the protocol with no protocol deviations, and who had available data for pharmacokinetic measurements. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
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| Secondary | Minimum Concentration (Cmin) of MK-4621 | Cmin was defined as the minimum or "trough" concentration of MK-4621 observed after its administration and just prior to the administration of a subsequent dose. Blood samples were collected at multiple time points (pre-dose and post-dose) during the study to assess the Cmin of MK-4621. | The Per Protocol population included all randomized participants who received at least 1 dose of study treatment, who complied with the protocol with no protocol deviations, and who had available data for pharmacokinetic measurements. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
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| Secondary | Maximum Concentration (Cmax) of MK-4621 | Cmax was defined as the maximum or "peak" concentration of MK-4621 observed after its administration. Blood samples were collected at multiple time points (pre-dose and post-dose) to assess the Cmax of MK-4621. | The Per Protocol population included all randomized participants who received at least 1 dose of study treatment, who complied with the protocol with no protocol deviations, and who had available data for pharmacokinetic measurements. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 of 21-day Cycles 1 and 2: pre-dose (1-8 hours), end of IT injection up to +5 minutes (0.0 hours), 0.5, 1.0, 2, 4, and 6 hours. Samples also collected at 24 hours after MK-4621 dose for Cycle 1 Day 1 only. |
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| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, ≥30% decrease in the sum of diameters of target lesions) as assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based upon investigator assessment. ORR was reported for each treatment arm. | All randomized participants who received at least 1 dose of study treatment and had a baseline scan that demonstrated measurable disease by the investigator's assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 22 months (through data cut-off of 02-Mar-2021) |
|
Up to approximately 22 months (through data cut-off of 02-Mar-2021)
All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs.
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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 | MK-4621 0.4 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.4 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab at a fixed dose 200 mg every 3 weeks (Q3W) for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. | 7 | 7 | 6 | 7 | 7 | 7 |
| EG001 | MK-4621 0.6 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.6 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. | 4 | 5 | 3 | 5 | 5 | 5 |
| EG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. | 13 | 18 | 11 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dental paraesthesia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastrointestinal oedema | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Extravasation | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Implant site inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Injection site infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Tri-iodothyronine free decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, 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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jan 19, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|
| OG002 | MK-4621 0.8 mg + Pembrolizumab (Arm 2) | Participants received MK-4621 0.8 mg Q1W during each 21-day cycle for a maximum duration of 6 cycles in combination with pembrolizumab 200 mg Q3W for a maximum duration of 6 cycles. Participants could continue to receive pembrolizumab monotherapy after Cycle 6 for up to 35 cycles (Cycles 7-35, approximately 2 years) from the start of treatment. |
|
|