Trial · NCT01704287
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)
NCT01704287, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2017-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002). Trials, record NCT01704287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704287
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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 Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)
- NCT number
- NCT01704287
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 540 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Malignant Melanoma
- Interventions
- Pembrolizumab, Carboplatin, Paclitaxel, Dacarbazine, Temozolomide
- First posted
- 2012-10-11
- Last updated
- 2020-05-18
- Other registries' IDs
- eudract:2012-003030-17
- Results first posted
- 2017-03-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD 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 also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS. |
| Primary | Interim Overall Survival (OS) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS. |
| Primary | Final Overall Survival (OS) - Initial Treatment Period | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS. |
| Secondary | Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented. |
| Secondary | Overall Response Rate (ORR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR. |
| Secondary | Best Overall Response (BOR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented. |
| Secondary | Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented. |
| Secondary | Duration of Response (DOR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | For participants who demonstrated a confirmed response (Complete Response \[CR\]: disappearance of all target lesions or Partial Response \[PR\]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) - Overall Study | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Months | MEDIAN |
| PRIMARY | Interim Overall Survival (OS) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Months | MEDIAN |
| PRIMARY | Final Overall Survival (OS) - Initial Treatment Period | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Months | MEDIAN |
| SECONDARY | Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Best Overall Response (BOR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) - Initial Treatment Period | Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015) | The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) - Overall Study | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | The analysis population consisted of all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study | Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019) | The analysis population consisted of all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) - Initial Treatment Period | Pembrolizumab 2 mg/kg | 2.9 | 95% Confidence Interval 2.8 to 3.8 | Months | |
| Progression-free Survival (PFS) - Initial Treatment Period | Pembrolizumab 10 mg/kg | 3.0 | 95% Confidence Interval 2.8 to 5.2 | Months | |
| Progression-free Survival (PFS) - Initial Treatment Period | Investigator-Choice Chemotherapy (ICC) | 2.8 | 95% Confidence Interval 2.6 to 2.8 | Months | |
| Interim Overall Survival (OS) - Initial Treatment Period | Pembrolizumab 2 mg/kg | 13.4 | 95% Confidence Interval 11.0 to 16.4 | Months | |
| Interim Overall Survival (OS) - Initial Treatment Period | Pembrolizumab 10 mg/kg | 14.7 | 95% Confidence Interval 11.3 to 19.5 | Months | |
| Interim Overall Survival (OS) - Initial Treatment Period | Investigator-Choice Chemotherapy (ICC) | 11.0 | 95% Confidence Interval 8.9 to 13.8 | Months | |
| Final Overall Survival (OS) - Initial Treatment Period | Pembrolizumab 2 mg/kg | 13.4 | 95% Confidence Interval 11.0 to 16.4 | Months | |
| Final Overall Survival (OS) - Initial Treatment Period | Pembrolizumab 10 mg/kg | 14.7 | 95% Confidence Interval 11.3 to 19.5 | Months | |
| Final Overall Survival (OS) - Initial Treatment Period | Investigator-Choice Chemotherapy (ICC) | 11.0 | 95% Confidence Interval 8.9 to 13.8 | Months | |
| Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period | Pembrolizumab 2 mg/kg | PD-L1 Positive | 15.0 | 95% Confidence Interval 10.9 to 20.9 | Months |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period | STARTED | Pembrolizumab 2 mg/kg | 180 | |
| Initial Treatment Period | STARTED | Pembrolizumab 10 mg/kg | 181 | |
| Initial Treatment Period | STARTED | Investigator-Choice Chemotherapy (ICC) | 179 | |
| Initial Treatment Period | STARTED | ICC→Pembrolizumab 2 mg/kg | 0 | |
| Initial Treatment Period | STARTED | ICC→Pembrolizumab 10 mg/kg | 0 | |
| Initial Treatment Period | Treated | Pembrolizumab 2 mg/kg | 178 | |
| Initial Treatment Period | Treated | Pembrolizumab 10 mg/kg | 179 | |
| Initial Treatment Period | Treated | Investigator-Choice Chemotherapy (ICC) | 171 | |
| Initial Treatment Period | Treated | ICC→Pembrolizumab 2 mg/kg | 0 | |
| Initial Treatment Period | Treated | ICC→Pembrolizumab 10 mg/kg | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events2,226
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 | Anaemia | Blood and lymphatic system disorders | Investigator-Choice Chemotherapy (ICC) Only | 21 | 73 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab) | 15 | 53 | 25 |
| other | Anaemia | Blood and lymphatic system disorders | ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab) | 10 | 45 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab 2 mg/kg | 30 | 178 | 43 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab 10 mg/kg | 26 | 179 | 31 |
| other | Anaemia | Blood and lymphatic system disorders | ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab) | 12 | 53 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab) | 8 | 45 | 21 |
| other | Hypothyroidism | Endocrine disorders | Investigator-Choice Chemotherapy (ICC) Only | 0 | 73 | 0 |
| other | Hypothyroidism | Endocrine disorders | ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab) | 0 | 53 | 0 |
| other | Hypothyroidism | Endocrine disorders | ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab) | 1 | 45 | 1 |
1 to 10 of 2,226Source ClinicalTrials.gov
See all 2,226 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Investigator-Choice Chemotherapy (ICC) Only | 71 | 73 |
| Total, all-cause mortality | ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab) | 0 | 53 |
| Total, all-cause mortality | ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab) | 0 | 45 |
| Total, all-cause mortality | Pembrolizumab 2 mg/kg | 139 | 178 |
| Total, all-cause mortality | Pembrolizumab 10 mg/kg | 129 | 179 |
| Total, all-cause mortality | ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab) | 35 | 53 |
| Total, all-cause mortality | ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab) | 37 | 45 |
| Total, other adverse events | Investigator-Choice Chemotherapy (ICC) Only | 66 | 73 |
| Total, other adverse events | ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab) | 52 | 53 |
| Total, other adverse events | ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab) | 44 | 45 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01704287
GET https://conductscience.org/api/trials/v1/NCT01704287/results?page=2