Trial · NCT02460198
Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
NCT02460198, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2020-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164). Trials, record NCT02460198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02460198
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
- NCT number
- NCT02460198
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Colorectal Carcinoma
- Interventions
- Pembrolizumab
- First posted
- 2015-06-02
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2015-001852-32
- Results first posted
- 2020-08-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor | Up to approximately 48 months | Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019. |
| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Up to approximately 66 months | Disease Control Rate was defined as the percentage of participants who achieved confirmed CR or PR or had demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. or the appearance of new lesion(s). Participants in the analysis population with missing DCR were considered as disease not under control. The data cutoff date was 19-Feb-2021. |
| Secondary | Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Up to approximately 66 months | PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest 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 progression). PFS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021. |
| Secondary | Overall Survival (OS) | Up to approximately 66 months | OS is defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE). | Up to approximately 66 months | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE. | Up to approximately 36 months | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor | Up to approximately 66 months | For participants who demonstrated a CR or PR, duration of response was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. Duration of Response was based on Independent radiologist review (IRC) using RECIST 1.1 and was summarized by Kaplan-Meier (KM) methods for censored data. Nonresponders were excluded from the analysis of DOR. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor | Up to approximately 48 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Up to approximately 66 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Up to approximately 66 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 66 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE). | Up to approximately 66 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE. | Up to approximately 36 months | The analysis population consisted of all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor | Up to approximately 66 months | The analysis population consisted of all participants who received at least one dose of study treatment and demonstrated a CR or PR. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor | Cohort A - Pembrolizumab 200 mg | 32.8 | 95% Confidence Interval 21.3 to 46.0 | Percentage of participants | |
| Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor | Cohort B - Pembrolizumab 200 mg | 34.9 | 95% Confidence Interval 23.3 to 48.0 | Percentage of participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Cohort A - Pembrolizumab 200 mg | 50.8 | 95% Confidence Interval 37.7 to 63.9 | Percentage of participants | |
| Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Cohort B - Pembrolizumab 200 mg | 55.6 | 95% Confidence Interval 42.5 to 68.1 | Percentage of participants | |
| Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Cohort A - Pembrolizumab 200 mg | 2.3 | 95% Confidence Interval 2.1 to 8.1 | Months | |
| Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor. | Cohort B - Pembrolizumab 200 mg | 4.1 | 95% Confidence Interval 2.1 to 18.9 | Months | |
| Overall Survival (OS) | Cohort A - Pembrolizumab 200 mg | 31.4 | 95% Confidence Interval 21.4 to 58 | Months | |
| Overall Survival (OS) | Cohort B - Pembrolizumab 200 mg | 47 | 95% Confidence Interval 19.2 to NA | Months | |
| Number of Participants Who Experienced an Adverse Event (AE). | Cohort A - Pembrolizumab 200 mg | 60 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE). | Cohort B - Pembrolizumab 200 mg | 63 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A - Pembrolizumab 200 mg | 61 | |
| Overall Study | STARTED | Cohort B - Pembrolizumab 200 mg | 63 | |
| Overall Study | COMPLETED | Cohort A - Pembrolizumab 200 mg | 0 | |
| Overall Study | COMPLETED | Cohort B - Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Cohort A - Pembrolizumab 200 mg | 61 | |
| Overall Study | NOT COMPLETED | Cohort B - Pembrolizumab 200 mg | 63 |
Source ClinicalTrials.gov
Adverse events672
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 | Cohort A First Course | 12 | 61 | 21 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B First Course | 11 | 63 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A Second Course | 2 | 6 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B Second Course | 1 | 3 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort A First Course | 1 | 61 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort B First Course | 2 | 63 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort A Second Course | 0 | 6 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Cohort B Second Course | 1 | 3 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Cohort A First Course | 4 | 61 | 5 |
| other | Hyperthyroidism | Endocrine disorders | Cohort B First Course | 7 | 63 | 7 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A First Course | 38 | 61 |
| Total, all-cause mortality | Cohort B First Course | 31 | 63 |
| Total, all-cause mortality | Cohort A Second Course | 0 | 6 |
| Total, all-cause mortality | Cohort B Second Course | 0 | 3 |
| Total, other adverse events | Cohort A First Course | 56 | 61 |
| Total, other adverse events | Cohort B First Course | 58 | 63 |
| Total, other adverse events | Cohort A Second Course | 5 | 6 |
| Total, other adverse events | Cohort B Second Course | 3 | 3 |
| Total, serious adverse events | Cohort A First Course | 31 | 61 |
| Total, serious adverse events | Cohort B First Course | 25 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A - Pembrolizumab 200 mg vs Cohort B - Pembrolizumab 200 mg: Number of Participants Who Experienced an Adverse Event (AE). | Trial comparisons |
| Cohort A - Pembrolizumab 200 mg vs Cohort B - Pembrolizumab 200 mg: Number of Participants Who Discontinued Study Treatment Due to an AE. | 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/NCT02460198
GET https://conductscience.org/api/trials/v1/NCT02460198/events?page=2