Trial · NCT02362594
Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
NCT02362594, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2019-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054). Trials, record NCT02362594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02362594
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
- NCT number
- NCT02362594
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,019 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Melanoma
- Interventions
- pembrolizumab, placebo
- First posted
- 2015-02-13
- Last updated
- 2026-03-05
- Other registries' IDs
- eudract:2014-004944-37
- Results first posted
- 2019-01-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants | 6 months | RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1. |
| Primary | Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression | 6 months | RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1. |
| Secondary | Distant Metastases-free Survival (DMFS) in All Participants | Up to approximately 11 years | DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants in both treatment arms. |
| Secondary | Distant Metastases-free Survival (DMFS) for Participants With PD-L1-positive Tumor Expression | Up to approximately 11 years | Description: DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants with PD-L1-positive tumors in both treatment arms. |
| Secondary | Overall Survival (OS) for All Participants | Up to approximately 11 years | OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants in both treatment arms. |
| Secondary | Overall Survival (OS) for Participants With PD-L1-positive Tumor Expression | Up to approximately 11 years | OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants with PD-L1-positive tumors in both treatment arms. |
| Secondary | Number of Participants Who Experienced At Least 1 Adverse Event (AE) | Up to 22 months | An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to 22 months | An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who discontinued study treatment due to an AE was reported for all participants in each treatment arm. |
| Secondary | Clearance (CL) of Pembrolizumab | Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks. | Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab CL, defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Samples were not collected and this analysis was not performed. |
| Secondary | Volume of Distribution (V) of Pembrolizumab | Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks. | Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab V, defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Samples were not collected and this analysis was not performed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants | 6 months | All randomized participants in Part 1. | Percentage of Participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression | 6 months | All randomized participants in Part 1 with PD-L1-positive tumors. | Percentage of Participants | NUMBER |
| SECONDARY | Distant Metastases-free Survival (DMFS) in All Participants | Up to approximately 11 years | |||
| SECONDARY | Distant Metastases-free Survival (DMFS) for Participants With PD-L1-positive Tumor Expression | Up to approximately 11 years | |||
| SECONDARY | Overall Survival (OS) for All Participants | Up to approximately 11 years | |||
| SECONDARY | Overall Survival (OS) for Participants With PD-L1-positive Tumor Expression | Up to approximately 11 years | |||
| SECONDARY | Number of Participants Who Experienced At Least 1 Adverse Event (AE) | Up to 22 months | All randomized participants in Part 1 who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to 22 months | All randomized participants in Part 1 who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clearance (CL) of Pembrolizumab | Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks. | As pre-specified by the protocol, pembrolizumab CL was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab pharmacokinetics (PK) in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications. | ||
| SECONDARY | Volume of Distribution (V) of Pembrolizumab | Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks. | As pre-specified by the protocol, pembrolizumab V was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab PK in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants | Pembrolizumab | 82.2 | 95% Confidence Interval 78.6 to 85.3 | Percentage of Participants | |
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants | Placebo | 73.3 | 95% Confidence Interval 69.2 to 77.0 | Percentage of Participants | |
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression | Pembrolizumab | 83.8 | 95% Confidence Interval 80.0 to 87.0 | Percentage of Participants | |
| Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression | Placebo | 75.4 | 95% Confidence Interval 71.0 to 79.2 | Percentage of Participants | |
| Number of Participants Who Experienced At Least 1 Adverse Event (AE) | Pembrolizumab | 475 | Participants | ||
| Number of Participants Who Experienced At Least 1 Adverse Event (AE) | Placebo | 453 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Pembrolizumab | 70 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Placebo | 18 | Participants | ||
| Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment | Pembrolizumab | Negative | 473 | Participants | |
| Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment | Pembrolizumab | Non-Treatment emergent positive | 5 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 514 | |
| Overall Study | STARTED | Placebo | 505 | |
| Overall Study | Treated | Pembrolizumab | 509 | |
| Overall Study | Treated | Placebo | 502 | |
| Overall Study | Continuing Part 1 Adjuvant Therapy | Pembrolizumab | 41 | |
| Overall Study | Continuing Part 1 Adjuvant Therapy | Placebo | 21 | |
| Overall Study | COMPLETED | Pembrolizumab | 264 | |
| Overall Study | COMPLETED | Placebo | 280 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 250 | |
| Overall Study | NOT COMPLETED | Placebo | 225 |
Source ClinicalTrials.gov
Adverse events356
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab | 52 | 509 | 61 |
| other | Hyperthyroidism | Endocrine disorders | Placebo | 6 | 502 | 6 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab | 75 | 509 | 93 |
| other | Hypothyroidism | Endocrine disorders | Placebo | 14 | 502 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab | 37 | 509 | 40 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 31 | 502 | 37 |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab | 34 | 509 | 37 |
| other | Constipation | Gastrointestinal disorders | Placebo | 29 | 502 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | Pembrolizumab | 140 | 509 | 238 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 129 | 502 | 234 |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 25 | 514 |
| Total, all-cause mortality | Placebo | 35 | 505 |
| Total, other adverse events | Pembrolizumab | 443 | 509 |
| Total, other adverse events | Placebo | 409 | 502 |
| Total, serious adverse events | Pembrolizumab | 128 | 509 |
| Total, serious adverse events | Placebo | 82 | 502 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab vs Placebo: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab vs Placebo: Number of Participants Who Experienced At Least 1 Adverse Event (AE) | Trial comparisons |
| Pembrolizumab vs Placebo: deaths from any cause | Trial comparisons |
| Pembrolizumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02362594
GET https://conductscience.org/api/trials/v1/NCT02362594/events?page=2