Trial · NCT02494583
Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
NCT02494583, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2020-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062). Trials, record NCT02494583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02494583
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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 First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
- NCT number
- NCT02494583
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 763 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Pembrolizumab, Cisplatin, 5-FU, Capecitabine, Placebo
- First posted
- 2015-07-10
- Last updated
- 2023-04-13
- Other registries' IDs
- eudract:2015-000972-88
- Results first posted
- 2020-03-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 36 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record. |
| Primary | Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record. |
| Primary | Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10 | Up to approximately 42 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record. |
| Primary | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record. |
| Primary | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10 | Up to approximately 42 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record. |
| Secondary | Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record. |
| Secondary | Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 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. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record. |
| Secondary | Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record. |
| Secondary | Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 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. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record. |
| Secondary | Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 36 months | All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10 | Up to approximately 42 months | All CPS ≥10 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10 | Up to approximately 42 months | All CPS ≥10 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants) | Up to approximately 42 months | All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis. | Months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants) | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 6.9 | 95% Confidence Interval 5.7 to 7.3 | Months | |
Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants) | Placebo + SOC Chemotherapy (SOC) | 6.4 | 95% Confidence Interval 5.7 to 7.0 | Months | |
| Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants) | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 12.5 | 95% Confidence Interval 10.8 to 13.9 | Months | |
| Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants) | Placebo + SOC Chemotherapy (SOC) | 11.1 | 95% Confidence Interval 9.2 to 12.8 | Months | |
| Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10 | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 12.3 | 95% Confidence Interval 9.5 to 14.8 | Months | |
| Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10 | Placebo + SOC Chemotherapy (SOC) | 10.8 | 95% Confidence Interval 8.5 to 13.8 | Months | |
| Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants) | Pembrolizumab Monotherapy (Pembro Mono) | 10.6 | 95% Confidence Interval 7.7 to 13.8 | Months | |
| Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants) | Placebo + SOC Chemotherapy (SOC) | 11.1 | 95% Confidence Interval 9.2 to 12.8 | Months | |
| Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10 | Pembrolizumab Monotherapy (Pembro Mono) | 17.4 | 95% Confidence Interval 9.1 to 23.1 | Months | |
| Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10 | Placebo + SOC Chemotherapy (SOC) | 10.8 | 95% Confidence Interval 8.5 to 13.8 | Months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab Monotherapy (Pembro Mono) | 256 | |
| Overall Study | STARTED | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 257 | |
| Overall Study | STARTED | Placebo + SOC Chemotherapy (SOC) | 250 | |
| Overall Study | Received First Course of Pembrolizumab | Pembrolizumab Monotherapy (Pembro Mono) | 254 | |
| Overall Study | Received First Course of Pembrolizumab | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 250 | |
| Overall Study | Received First Course of Pembrolizumab | Placebo + SOC Chemotherapy (SOC) | 244 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab Monotherapy (Pembro Mono) | 4 | |
| Overall Study | Received Second Course of Pembrolizumab | Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 5 | |
| Overall Study | Received Second Course of Pembrolizumab | Placebo + SOC Chemotherapy (SOC) | 0 | |
| Overall Study | COMPLETED | Pembrolizumab Monotherapy (Pembro Mono) | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,375
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 Monotherapy (Pembro Mono) First Course | 61 | 254 | 73 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course | 112 | 250 | 150 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + SOC Chemotherapy (SOC)-First Course | 108 | 244 | 144 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy Second Course | 3 | 4 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + SOC Chemotherapy-Second Course | 0 | 5 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy (Pembro Mono) First Course | 0 | 254 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course | 21 | 250 | 52 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + SOC Chemotherapy (SOC)-First Course | 26 | 244 | 51 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy Second Course | 0 | 4 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + SOC Chemotherapy-Second Course | 0 | 5 | 0 |
1 to 10 of 1,375Source ClinicalTrials.gov
See all 1,375 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab Monotherapy (Pembro Mono) First Course | 229 | 256 |
| Total, all-cause mortality | Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course | 232 | 257 |
| Total, all-cause mortality | Placebo + SOC Chemotherapy (SOC)-First Course | 240 | 250 |
| Total, all-cause mortality | Pembrolizumab Monotherapy Second Course | 2 | 4 |
| Total, all-cause mortality | Pembrolizumab + SOC Chemotherapy-Second Course | 1 | 5 |
| Total, other adverse events | Pembrolizumab Monotherapy (Pembro Mono) First Course | 216 | 254 |
| Total, other adverse events | Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course | 239 | 250 |
| Total, other adverse events | Placebo + SOC Chemotherapy (SOC)-First Course | 234 | 244 |
| Total, other adverse events | Pembrolizumab Monotherapy Second Course | 3 | 4 |
| Total, other adverse events | Pembrolizumab + SOC Chemotherapy-Second Course | 5 | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
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.
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