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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-151 | Other Identifier | Merck Protocol Number | |
| KEYNOTE-151 | Other Identifier | Merck |
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The purpose of this study is to determine the safety, tolerability, and objective response rate (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or metastatic melanoma, with disease progression following first line chemotherapy or targeted therapy. ORR will be based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
With Amendment 6 (effective date 18-Mar-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and may be enrolled in an extension study to continue protocol-defined assessments and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive pembrolizumab 2 mg/kg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | Intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented. | Up to approximately 17 months (Through data cutoff date of 27-December-2017) |
| Number of Participants Who Discontinued Study Treatment Due to an AE | The number of all participants who discontinued study treatment due to an AE is presented. | Up to approximately 17 months (through data cutoff date of 27-December-2017) |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 assessed by blinded independent central review (BICR). The ORR per RECIST 1.1 for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. | Up to approximately 17 months (through data cutoff date of 27-December-2017) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from first day of study treatment to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. | Up to approximately 76 months |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
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Inclusion Criteria:
Is of the Chinese descent, was born in China, and has a Chinese home address.
Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy.
Participant may not have a diagnosis of uveal or ocular melanoma.
Overall proportion of participants with mucosa melanoma will be no more than 22%.
Has failed the first line chemotherapy (excluding adjuvant or neoadjuvant therapy) or targeted therapy for melanoma.
Has at least one measurable lesion as defined by RECIST 1.1 on imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]).
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Has an anticipated life expectancy of at least 3 months.
Demonstrates adequate organ function.
Has provided tissue for anti-programmed cell death ligand-1 (PD-L1) expression evaluation from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
Has documented BRAF mutation status or is willing to provide a tumor tissue for BRAF genotyping.
Females may be enrolled in the study if they are:
Of non-childbearing potential which is defined as:
Female and male participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30981094 | Result | Si L, Zhang X, Shu Y, Pan H, Wu D, Liu J, Lou F, Mao L, Wang X, Wen X, Gu Y, Zhu L, Lan S, Cai X, Diede SJ, Zhou Y, Ge J, Li J, Wu H, Guo J. A Phase Ib Study of Pembrolizumab as Second-Line Therapy for Chinese Patients With Advanced or Metastatic Melanoma (KEYNOTE-151). Transl Oncol. 2019 Jun;12(6):828-835. doi: 10.1016/j.tranon.2019.02.007. Epub 2019 Apr 10. | |
| 36304457 |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Participants received pembrolizumab 2 mg/kg intravenous (IV) on Day 1 of each 21-day cycle. Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 2 mg/kg on day 1 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Participants received pembrolizumab 2 mg/kg intravenous (IV) on Day 1 of each 21-day cycle. Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 2 mg/kg on day 1 of each 21-day cycle. |
| 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 | All enrolled participants |
| 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 | Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented. | The safety population consisted of all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 17 months (Through data cutoff date of 27-December-2017) |
|
Up to approximately 76 months.
The safety population consisted of all participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered a serious AE (SAE) unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as SAEs. One person who withdrew from the study (see participant flow) subsequently died.
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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 | Pembrolizumab | Participants received pembrolizumab 2 mg/kg IV on Day 1 of each 21-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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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 | Mar 18, 2022 | Nov 10, 2023 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per RECIST 1.1 for participants is presented. |
| Up to approximately 76 months |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until disease progression or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. | Up to approximately 76 months |
| Objective Response Rate (ORR) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or a Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST assessed by blinded independent central review (BICR). The ORR per irRECIST for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. | Up to approximately 76 months |
| Progression-free Survival (PFS) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRECIST based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per irRECIST for participants is presented. | Up to approximately 76 months |
| Duration of Response (DOR) by Immune-related Response Evaluation Criteria in Solid Tumors Version (irRECIST) | DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST until disease progression or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. | Up to approximately 76 months |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 2 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 2 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 2 is presented. | Day 21: Prior to the Cycle 2 (21-day cycle) Dose |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 4 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 4 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 4 is presented. | Day 63: Prior to the Cycle 4 (21-day cycle) Dose |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 6 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 6 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 6 is presented. | Day 105: Prior to the Cycle 6 (21-day cycle) Dose |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 8 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 8 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 8 is presented. | Day 147: Prior to the Cycle 8 (21-day cycle) Dose |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 12 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 12 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 12 is presented. | Day 231: Prior to the Cycle 12 (21-day cycle) Dose |
| Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 16 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 16 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 16 is presented. | Day 315: Prior to the Cycle 16 (21-day cycle) Dose |
| Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 1 (21-day cycle). The Cmax of pembrolizumab is presented. | Day 0: 30 minutes after the end of infusion during Cycle 1 (21-day cycle) |
| Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 8 (21-day Cycle) | Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 8 (21-day cycle). The Cmax of pembrolizumab is presented. | Day 147: 30 minutes after the end of infusion during Cycle 8 (21-day cycle) |
| Observed Serum Concentration of Pembrolizumab 1 Day After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 1 day after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | Day 2: 1 day after the end of infusion during Cycle 1 (21-day cycle) |
| Observed Serum Concentration of Pembrolizumab 5 Days After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 5 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | Day 6: 5 days after the end of infusion during Cycle 1 (21-day cycle) |
| Observed Serum Concentration of Pembrolizumab 14 Days After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 14 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | Day 15: 14 days after the end of infusion during Cycle 1 (21-day cycle) |
| Si L, Zhang X, Shu Y, Pan H, Wu D, Liu J, Mao L, Wang X, Wen X, Gu Y, Zhu L, Lan S, Cai X, Diede SJ, Dai H, Niu C, Li J, Guo J. Pembrolizumab in Chinese patients with advanced melanoma: 3-year follow-up of the KEYNOTE-151 study. Front Immunol. 2022 Oct 11;13:882471. doi: 10.3389/fimmu.2022.882471. eCollection 2022. |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | All enrolled participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | The race of participants is presented. | All enrolled participants | Count of Participants | Participants |
|
| Programmed Cell Death-Ligand 1 (PD-L1) Expression Status | Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using archival tumor tissue or tumor tissue from a newly obtained biopsy. The PD-L1 tumor expression status of participants is presented. | All enrolled participants | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature; Grade 2: Ambulatory & capable of all selfcare but unable to carry out any work activities, up & about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead. | All enrolled participants | Count of Participants | Participants |
|
| BRAF Mutation Expression Status | BRAF mutation status was required from all participants. For participants that did not have a prior documented BRAF mutation status, BRAF V600 mutation analysis was performed by polymerase chain reaction (PCR) on tumor tissue. The BRAF mutation status of participants is presented. | All enrolled participants | Count of Participants | Participants |
|
| Pembrolizumab |
Participants received pembrolizumab 2 mg/kg IV on Day 1 of each 21-day cycle. |
|
|
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | The number of all participants who discontinued study treatment due to an AE is presented. | The safety population consisted of all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 17 months (through data cutoff date of 27-December-2017) |
|
|
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| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 assessed by blinded independent central review (BICR). The ORR per RECIST 1.1 for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. | The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 17 months (through data cutoff date of 27-December-2017) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from first day of study treatment to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. | The analysis population consisted of all participants who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
|
|
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| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per RECIST 1.1 for participants is presented. | The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
|
|
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| Secondary | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until disease progression or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. | The analysis population consisted of all participants who received at least one dose of study treatment, had measurable disease at baseline, and had confirmed CR or PR. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
|
|
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| Secondary | Objective Response Rate (ORR) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or a Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST assessed by blinded independent central review (BICR). The ORR per irRECIST for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. | The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 76 months |
|
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| Secondary | Progression-free Survival (PFS) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRECIST based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per irRECIST for participants is presented. | The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
|
|
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| Secondary | Duration of Response (DOR) by Immune-related Response Evaluation Criteria in Solid Tumors Version (irRECIST) | DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST until disease progression or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. | The analysis population consisted of all participants who received at least one dose of study treatment, had measurable disease at baseline, and had confirmed CR or PR. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 76 months |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 2 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 2 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 2 is presented. | The analysis population consisted of participants who received 1 dose of study treatment, completed Cycle 1 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 21: Prior to the Cycle 2 (21-day cycle) Dose |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 4 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 4 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 4 is presented. | The analysis population consisted of participants who received 3 doses of study treatment, completed Cycle 3 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 63: Prior to the Cycle 4 (21-day cycle) Dose |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 6 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 6 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 6 is presented. | The analysis population consisted of participants who received 5 doses of study treatment, completed Cycle 5 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 105: Prior to the Cycle 6 (21-day cycle) Dose |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 8 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 8 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 8 is presented. | The analysis population consisted of participants who received 7 doses of study treatment, completed Cycle 7 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 147: Prior to the Cycle 8 (21-day cycle) Dose |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 12 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 12 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 12 is presented. | The analysis population consisted of participants who received 11 doses of study treatment, completed Cycle 11 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 231: Prior to the Cycle 12 (21-day cycle) Dose |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 16 (21-day Cycle) | Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 16 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 16 is presented. | The analysis population consisted of participants who received 15 doses of study treatment, completed Cycle 15 (21-day cycle), and had blood samples drawn for Ctrough analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 315: Prior to the Cycle 16 (21-day cycle) Dose |
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| Secondary | Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 1 (21-day cycle). The Cmax of pembrolizumab is presented. | The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for Cmax analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 0: 30 minutes after the end of infusion during Cycle 1 (21-day cycle) |
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| Secondary | Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 8 (21-day Cycle) | Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 8 (21-day cycle). The Cmax of pembrolizumab is presented. | The analysis population consisted of participants who received 8 doses of study treatment and had blood samples drawn for Cmax analysis. | Posted | Mean | Standard Deviation | μg/mL | Day 147: 30 minutes after the end of infusion during Cycle 8 (21-day cycle) |
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| Secondary | Observed Serum Concentration of Pembrolizumab 1 Day After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 1 day after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab. | Posted | Mean | Standard Deviation | μg/mL | Day 2: 1 day after the end of infusion during Cycle 1 (21-day cycle) |
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|
|
| Secondary | Observed Serum Concentration of Pembrolizumab 5 Days After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 5 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab. | Posted | Mean | Standard Deviation | μg/mL | Day 6: 5 days after the end of infusion during Cycle 1 (21-day cycle) |
|
|
|
| Secondary | Observed Serum Concentration of Pembrolizumab 14 Days After The End of Infusion During Cycle 1 (21-day Cycle) | Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 14 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. | The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab. | Posted | Mean | Standard Deviation | μg/mL | Day 15: 14 days after the end of infusion during Cycle 1 (21-day cycle) |
|
|
|
| 90 |
| 103 |
| 13 |
| 103 |
| 98 |
| 103 |
| EG001 | Pembrolizumab Second Course | Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 2 mg/kg on day 1 of each 21-day cycle. | 0 | 1 | 0 | 1 | 1 | 1 |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |