Trial · NCT02563002
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
NCT02563002, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2022-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177). Trials, record NCT02563002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02563002
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
- NCT number
- NCT02563002
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Colorectal Carcinoma
- Interventions
- mFOLFOX6, FOLFIRI, Pembrolizumab, Bevacizumab, Cetuximab
- First posted
- 2015-09-29
- Last updated
- 2024-10-03
- Other registries' IDs
- eudract:2015-002024-89
- Results first posted
- 2022-03-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor | Up to approximately 59 months | PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol. |
| Primary | Overall Survival (OS) | Up to approximately 59 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol. |
| Secondary | Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor | Up to approximately 59 months | ORR was defined as the percentage of the participants who experienced 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) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 59 months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE was presented for the first course study treatment per protocol. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 59 months | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented for the first course study treatment per protocol. |
Source ClinicalTrials.gov
Outcomes5
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) Per RECIST1.1 As Assessed by Central Imaging Vendor | Up to approximately 59 months | All randomized participants | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 59 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor | Up to approximately 59 months | All randomized participants | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 59 months | All participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 59 months | All participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
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) Per RECIST1.1 As Assessed by Central Imaging Vendor | Pembrolizumab | 16.5 | 95% Confidence Interval 5.4 to 38.1 | Months | |
| Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor | Standard of Care (SOC) | 8.2 | 95% Confidence Interval 6.1 to 10.2 | Months | |
| Overall Survival (OS) | Pembrolizumab | NA | 95% Confidence Interval 49.2 to NA | Months | |
| Overall Survival (OS) | Standard of Care (SOC) | 36.7 | 95% Confidence Interval 27.6 to NA | Months | |
| Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor | Pembrolizumab | 45.1 | 95% Confidence Interval 37.1 to 53.3 | Percentage of Participants | |
| Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor | Standard of Care (SOC) | 33.1 | 95% Confidence Interval 25.8 to 41.1 | Percentage of Participants | |
| Number of Participants Who Experienced an Adverse Event (AE) | Pembrolizumab | 149 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Standard of Care (SOC) | 142 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Pembrolizumab | 21 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Standard of Care (SOC) | 20 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 153 | |
| Overall Study | STARTED | Standard of Care (SOC) | 154 | |
| Overall Study | Treated | Pembrolizumab | 153 | |
| Overall Study | Treated | Standard of Care (SOC) | 143 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab | 12 | |
| Overall Study | Received Second Course of Pembrolizumab | Standard of Care (SOC) | 5 | |
| Overall Study | Switched Over to Pembrolizumab | Pembrolizumab | 0 | |
| Overall Study | Switched Over to Pembrolizumab | Standard of Care (SOC) | 7 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,425
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 | Pembrolizumab First Course | 26 | 153 | 32 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) First Course | 33 | 143 | 40 |
| other | Anaemia | Blood and lymphatic system disorders | SOC Switched Over to Pembrolizumab | 9 | 57 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 1 | 12 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | SOC Switched Over to Pembrolizumab-Second Course | 0 | 5 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab First Course | 0 | 153 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Standard of Care (SOC) First Course | 3 | 143 | 12 |
| other | Leukopenia | Blood and lymphatic system disorders | SOC Switched Over to Pembrolizumab | 0 | 57 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 12 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | SOC Switched Over to Pembrolizumab-Second Course | 1 | 5 | 1 |
1 to 10 of 1,425Source ClinicalTrials.gov
See all 1,425 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab First Course | 68 | 153 |
| Total, all-cause mortality | Standard of Care (SOC) First Course | 58 | 154 |
| Total, all-cause mortality | SOC Switched Over to Pembrolizumab | 30 | 57 |
| Total, all-cause mortality | Pembrolizumab Second Course | 4 | 12 |
| Total, all-cause mortality | SOC Switched Over to Pembrolizumab-Second Course | 2 | 5 |
| Total, other adverse events | Pembrolizumab First Course | 145 | 153 |
| Total, other adverse events | Standard of Care (SOC) First Course | 142 | 143 |
| Total, other adverse events | SOC Switched Over to Pembrolizumab | 53 | 57 |
| Total, other adverse events | Pembrolizumab Second Course | 11 | 12 |
| Total, other adverse events | SOC Switched Over to Pembrolizumab-Second Course | 4 | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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 |
|---|---|
| Pembrolizumab vs Standard of Care (SOC): Number of Participants Who Discontinued Study Treatment Due to an AE | Trial comparisons |
| Pembrolizumab vs Standard of Care (SOC): Number of Participants Who Experienced an Adverse Event (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/NCT02563002
GET https://conductscience.org/api/trials/v1/NCT02563002/events?page=2