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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-161 | Other Identifier | Merck | |
| KEYNOTE-161 | Other Identifier | Merck |
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Lack of Accrual
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In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.
The primary hypotheses are that participants who respond to pembrolizumab have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Biological | 200 mg by IV infusion Q3W for up to 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants With Response Versus Participants With Progression | FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell ribonucleic acid (RNA) gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies. | Up to approximately 59 weeks |
| Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants With Response Versus Participants With Progression | ASCTFR is defined as the arithmetic average of the log10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment. | Up to approximately 59 weeks |
| Change in Baseline of Fraction of Cytotoxic T-lymphocytes (FCT) for Participants With Response Versus Participants With Progression | The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies. | Up to approximately 59 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced 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. The number of participants who experienced an AE is presented. | Up to approximately 59 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital ( Site 0102) | Boston | Massachusetts | 02114 | United States | ||
| Dana Farber Cancer Institute ( Site 0101) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Participants received pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Zero participants are reported due to the risk of identification of a person.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Participants received pembrolizumab 200 mg by IV infusion Q3W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants With Response Versus Participants With Progression | FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell ribonucleic acid (RNA) gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
Up to approximately 59 weeks
Zero participants are reported due to the risk of identification of a person.
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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 200 mg by IV infusion Q3W. |
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Study was stopped early due to lack of accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 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 | Jun 14, 2019 | Jun 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Number of Participants Who Discontinued Any Study Drug Due to an Adverse Event (AE) |
The number of participants who discontinued any study treatment due to an AE is presented. |
| Up to approximately 59 weeks |
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator. | Up to approximately 59 weeks |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator. | Up to approximately 59 weeks |
| Overall Survival (OS) | OS is defined as the time from the start of treatment to death due to any cause. | Up to approximately 59 weeks |
| Neoepitope Burden | Neoepitope sequencing will be generated based on single cell ribonucleic acid (RNA) sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden. | Up to approximately 59 weeks |
| Antigenic Determinants of Highly-functional CD8 + T-cell Clones | T-cell receptors (TCRs) from CD8+ T-cell clones will be identified by single cell ribonucleic acid (RNA) sequencing (scRNAseq) and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines. | Up to approximately 59 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Participants |
|
| Sex: Female, Male | Participants |
|
| Ethnicity (NIH/OMB) | Participants |
|
| Race (NIH/OMB) | Participants |
|
|
| Primary | Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants With Response Versus Participants With Progression | ASCTFR is defined as the arithmetic average of the log10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Primary | Change in Baseline of Fraction of Cytotoxic T-lymphocytes (FCT) for Participants With Response Versus Participants With Progression | The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Secondary | Number of Participants Who Experienced 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. The number of participants who experienced an AE is presented. | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 59 weeks |
|
|
|
| Secondary | Number of Participants Who Discontinued Any Study Drug Due to an Adverse Event (AE) | The number of participants who discontinued any study treatment due to an AE is presented. | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 59 weeks |
|
|
|
| Secondary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Secondary | Overall Survival (OS) | OS is defined as the time from the start of treatment to death due to any cause. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Secondary | Neoepitope Burden | Neoepitope sequencing will be generated based on single cell ribonucleic acid (RNA) sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
|
|
| Secondary | Antigenic Determinants of Highly-functional CD8 + T-cell Clones | T-cell receptors (TCRs) from CD8+ T-cell clones will be identified by single cell ribonucleic acid (RNA) sequencing (scRNAseq) and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | Up to approximately 59 weeks |
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The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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.