Trial · NCT02564263
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)
NCT02564263, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181). Trials, record NCT02564263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564263
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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 Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)
- NCT number
- NCT02564263
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 628 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Esophageal Carcinoma, Esophagogastric Junction Carcinoma
- Interventions
- pembrolizumab, paclitaxel, docetaxel, irinotecan
- First posted
- 2015-09-30
- Last updated
- 2023-03-13
- Other registries' IDs
- eudract:2015-002782-32
- Results first posted
- 2019-11-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented. |
| Primary | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented. |
| Primary | Overall Survival (OS) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented. |
| Secondary | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | 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 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented. |
| Secondary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented. |
| Secondary | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | 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 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus. |
| Secondary | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | 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 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10. |
| Secondary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented. |
| Secondary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR is presented. |
| Secondary | Number of Participants Experiencing an Adverse Event (AE) | Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced ≥1 AE is presented. |
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 | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing an Adverse Event (AE) | Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) | The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Pembrolizumab | 8.2 | 95% Confidence Interval 6.7 to 10.3 | Months | |
| Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Chemotherapy | 7.1 | 95% Confidence Interval 6.1 to 8.2 | Months | |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Pembrolizumab | 9.3 | 95% Confidence Interval 6.6 to 12.5 | Months | |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Chemotherapy | 6.7 | 95% Confidence Interval 5.1 to 8.2 | Months | |
| Overall Survival (OS) in All Participants | Pembrolizumab | 7.1 | 95% Confidence Interval 6.2 to 8.1 | Months | |
| Overall Survival (OS) in All Participants | Chemotherapy | 7.1 | 95% Confidence Interval 6.3 to 8.0 | Months | |
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab | 2.1 | 95% Confidence Interval 2.1 to 2.2 | Months | |
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Chemotherapy | 3.4 | 95% Confidence Interval 2.8 to 3.9 | Months | |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab | 13.1 | 95% Confidence Interval 9.5 to 17.3 | Percentage of Participants | |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Chemotherapy | 6.7 | 95% Confidence Interval 4.2 to 10.0 | Percentage of Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 | 314 | |
| Overall Study | STARTED | Chemotherapy | 314 | |
| Overall Study | Treated | Pembrolizumab | 314 | |
| Overall Study | Treated | Chemotherapy | 296 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab | 5 | |
| Overall Study | Received Second Course of Pembrolizumab | Chemotherapy | 0 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 314 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 314 |
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 | Pembrolizumab First Course | 52 | 314 | 60 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 83 | 296 | 110 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 1 | 5 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab First Course | 0 | 314 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 36 | 296 | 65 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab First Course | 37 | 314 | 40 |
| other | Hypothyroidism | Endocrine disorders | Chemotherapy | 7 | 296 | 7 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab Second Course | 1 | 5 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Pembrolizumab First Course | 7 | 314 | 7 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab First Course | 305 | 314 |
| Total, all-cause mortality | Chemotherapy | 305 | 314 |
| Total, all-cause mortality | Pembrolizumab Second Course | 3 | 5 |
| Total, other adverse events | Pembrolizumab First Course | 285 | 314 |
| Total, other adverse events | Chemotherapy | 281 | 296 |
| Total, other adverse events | Pembrolizumab Second Course | 5 | 5 |
| Total, serious adverse events | Pembrolizumab First Course | 127 | 314 |
| Total, serious adverse events | Chemotherapy | 121 | 296 |
| Total, serious adverse events | Pembrolizumab Second Course | 1 | 5 |
Source ClinicalTrials.gov
Papers2
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 Chemotherapy: Number of Participants Experiencing an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab vs Chemotherapy: Number of Participants Discontinuing Study Treatment Due 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/NCT02564263
GET https://conductscience.org/api/trials/v1/NCT02564263/results?page=2