Trial · NCT03933449
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
NCT03933449, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2020-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study. Trials, record NCT03933449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03933449
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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 of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
- NCT number
- NCT03933449
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 123 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Esophageal Carcinoma, Esophagogastric Junction Carcinoma
- Interventions
- pembrolizumab, paclitaxel, docetaxel, irinotecan
- First posted
- 2019-05-01
- Last updated
- 2023-03-29
- Results first posted
- 2020-02-26
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 All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented. |
| Primary | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented. |
| Primary | Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus 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 | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course 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) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course 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 Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course 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 | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 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 Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10. |
| 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 | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus. |
| Secondary | Number of Participants Experiencing an Adverse Event (AE) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are 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 All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | The efficacy analysis population consisted of all randomized participants. 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) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | The efficacy analysis population consisted of all randomized participants who experienced a confirmed response (CR or PR). 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) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10 who experienced a confirmed response (CR or PR). 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 Squamous Cell Carcinoma (SCC) of the Esophagus | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | The efficacy analysis population consisted of all randomized participants with SCC of the esophagus who experienced a confirmed response (CR or PR). 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 All Participants | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 | 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 | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 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 | Number of Participants Experiencing an Adverse Event (AE) | From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) | All randomized participants who received at least one dose of study treatment. | 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 All Participants | Pembrolizumab | 8.4 | 95% Confidence Interval 5.8 to 10.9 | Months | |
| Overall Survival (OS) in All Participants | Chemotherapy | 5.6 | 95% Confidence Interval 4.5 to 7.3 | Months | |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Pembrolizumab | 12.0 | 95% Confidence Interval 6.6 to NA | Months | |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) | Chemotherapy | 5.3 | 95% Confidence Interval 4.1 to 8.2 | Months | |
| Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Pembrolizumab | 8.4 | 95% Confidence Interval 5.8 to 10.9 | Months | |
| Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus | Chemotherapy | 5.6 | 95% Confidence Interval 4.5 to 7.3 | Months | |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants | Pembrolizumab | 16.1 | 95% Confidence Interval 8.0 to 27.7 | 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 | 3.3 | 95% Confidence Interval 0.4 to 11.3 | Percentage of Participants | |
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) | Pembrolizumab | 24.0 | 95% Confidence Interval 9.4 to 45.1 | Percentage of Participants | |
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) | Chemotherapy | 6.9 | 95% Confidence Interval 0.8 to 22.8 | Percentage of Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 62 | |
| Overall Study | STARTED | Chemotherapy | 61 | |
| Overall Study | Treated | Pembrolizumab | 62 | |
| Overall Study | Treated | Chemotherapy | 59 | |
| Overall Study | Received Second Course | Pembrolizumab | 1 | |
| Overall Study | Received Second Course | Chemotherapy | 0 | |
| Overall Study | Discontinued | Pembrolizumab | 62 | |
| Overall Study | Discontinued | Chemotherapy | 61 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Chemotherapy | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events333
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 | 19 | 62 | 24 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 30 | 59 | 49 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 1 | 1 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab First Course | 1 | 62 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 7 | 59 | 23 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 1 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab First Course | 0 | 62 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 5 | 59 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 1 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab First Course | 12 | 62 | 15 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab First Course | 61 | 62 |
| Total, all-cause mortality | Chemotherapy | 61 | 61 |
| Total, all-cause mortality | Pembrolizumab Second Course | 0 | 1 |
| Total, other adverse events | Pembrolizumab First Course | 58 | 62 |
| Total, other adverse events | Chemotherapy | 55 | 59 |
| Total, other adverse events | Pembrolizumab Second Course | 1 | 1 |
| Total, serious adverse events | Pembrolizumab First Course | 23 | 62 |
| Total, serious adverse events | Chemotherapy | 23 | 59 |
| Total, serious adverse events | Pembrolizumab Second Course | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34973513 | RESULT |
Source PubMed
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/NCT03933449
GET https://conductscience.org/api/trials/v1/NCT03933449/results?page=2