Trial Outcomes & Findings for Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161) (NCT NCT03407170)
NCT ID: NCT03407170
Last Updated: 2020-07-15
Results Overview
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.
TERMINATED
PHASE2
1 participants
Up to approximately 59 weeks
2020-07-15
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment.
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.
Outcome measures
| Measure |
Pembrolizumab
n=1 Participants
Participants received pembrolizumab 200 mg by IV infusion Q3W.
|
|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment.
The number of participants who discontinued any study treatment due to an AE is presented.
Outcome measures
| Measure |
Pembrolizumab
n=1 Participants
Participants received pembrolizumab 200 mg by IV infusion Q3W.
|
|---|---|
|
Number of Participants Who Discontinued Any Study Drug Due to an Adverse Event (AE)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
OS is defined as the time from the start of treatment to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 59 weeksPopulation: No data were collected or analyzed for this outcome measure due to early termination of the study.
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.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER