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| ID | Type | Description | Link |
|---|---|---|---|
| 173739 | Registry Identifier | JAPIC-CTI | |
| MK-3475-590 | Other Identifier | MSD | |
| KEYNOTE-590 | Other Identifier | MSD | |
| 2017-000958-19 | EudraCT Number |
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The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.
The overall primary efficacy hypotheses are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + SOC | Experimental | Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
| Placebo + SOC | Placebo Comparator | Participants receive placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | 200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10) | Overall survival 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 is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS ≥10. | Up to approximately 34 months |
| OS in Participants With ESCC | Overall survival 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 is reported here for all participants of the ITT population (all randomized) who had ESCC. | Up to approximately 34 months |
| OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Overall survival 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 is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | Up to approximately 34 months |
| OS in All Participants | Overall survival 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 is reported here for all participants of the ITT population (all randomized). | Up to approximately 34 months |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California ( Site 0003) | West Los Angeles | California | 90034 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42047965 | Derived | Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Yatsuzuka N, Sakata T, Han S, Doi T. First-line pembrolizumab plus chemotherapy versus chemotherapy alone for advanced esophageal cancer: 5-year extended follow-up in the Japanese subgroup of KEYNOTE-590. Esophagus. 2026 Apr 28. doi: 10.1007/s10388-026-01200-8. Online ahead of print. | |
| 41620988 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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749 participants were randomized 1:1 to receive either pembrolizumab plus standard of care (SOC) chemotherapy, or placebo plus SOC chemotherapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + SOC | Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-fluorouracil (5-FU) 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2022 |
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| Placebo | Drug | Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations. |
|
| Cisplatin | Drug | 80 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses. |
|
| 5-FU | Drug | 800 mg/m^2/day (4000 mg/m^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations. |
|
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who had ESCC. |
| Up to approximately 34 months |
| PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | Up to approximately 34 months |
| PFS Per RECIST 1.1 As Assessed By Investigator in All Participants | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized). | Up to approximately 34 months |
| Up to approximately 34 months |
| ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC and who were PD-L1 CPS ≥10. | Up to approximately 34 months |
| ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC. | Up to approximately 34 months |
| ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | Up to approximately 34 months |
| Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR. | Up to approximately 34 months |
| DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC and were PD-L1 CPS ≥10. | Up to approximately 34 months |
| DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC. | Up to approximately 34 months |
| DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and were PD-L1 CPS ≥10. | Up to approximately 34 months |
| Number of Participants With an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did 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 that experienced at least one AE was reported for each treatment arm. | Up to approximately 28 months |
| Number of Participants Discontinuing Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did 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 that discontinued any study drug due to an AE was reported for each treatment arm. | Up to approximately 27 months |
| Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants. | Baseline, Week 18 |
| Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC and who were PD-L1 CPS ≥10. | Baseline, Week 18 |
| Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC. | Baseline, Week 18 |
| Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who were PD-L1 CPS ≥10. | Baseline, Week 18 |
| Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 |
| Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 |
| Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 |
| Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 |
| The University of Chicago Medical Center ( Site 0001) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| University of Kansas ( Site 0029) | Westwood | Kansas | 66205 | United States |
| University of Maryland Medical Center ( Site 0013) | Baltimore | Maryland | 21201 | United States |
| Dana Farber Cancer Center ( Site 0009) | Boston | Massachusetts | 02215 | United States |
| Henry Ford Cancer Center ( Site 0018) | Detroit | Michigan | 48202 | United States |
| Washington University School of Medicine ( Site 0031) | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute ( Site 0004) | Buffalo | New York | 14263 | United States |
| Weill Cornell Medical College ( Site 0024) | New York | New York | 10065 | United States |
| University Hospitals Cleveland Medical Center ( Site 0002) | Cleveland | Ohio | 44106 | United States |
| UPMC Cancer Center/Hillman Cancer Center ( Site 0015) | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Tennessee Medical Center Knoxville ( Site 0017) | Knoxville | Tennessee | 37920 | United States |
| Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603) | Viedma | Río Negro Province | R8500ACE | Argentina |
| Hospital Aleman ( Site 0605) | Buenos Aires | C1118AAT | Argentina |
| Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602) | Buenos Aires | C1264AAA | Argentina |
| Sanatorio Allende - Cordoba ( Site 0604) | Córdoba | X5000JHQ | Argentina |
| Hospital Privado Centro Medico Cordoba ( Site 0601) | Córdoba | X5016KEH | Argentina |
| Blacktown Hospital ( Site 2000) | Blacktown | New South Wales | 2148 | Australia |
| Liverpool Hospital. ( Site 2001) | Liverpool | New South Wales | 2170 | Australia |
| Princess Alexandra Hospital ( Site 2005) | Woolloongabba | Queensland | 4102 | Australia |
| Eastern Health ( Site 2002) | Box Hill | Victoria | 3128 | Australia |
| Peter MacCallum Cancer Centre ( Site 2003) | Melbourne | Victoria | 3000 | Australia |
| CETUS Hospital Dia Oncologia ( Site 0208) | Belo Horizonte | Minas Gerais | 30110-022 | Brazil |
| Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210) | Recife | Pernambuco | 50070-550 | Brazil |
| Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209) | Rio de Janeiro | Rio de Janeiro | 20231-050 | Brazil |
| Hospital Sao Vicente de Paulo ( Site 0204) | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211) | Santa Maria | Rio Grande do Sul | 97015-513 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203) | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital Alemao Oswaldo Cruz ( Site 0207) | São Paulo | São Paulo | 01323-903 | Brazil |
| Hospital de Clinicas de Porto Alegre ( Site 0200) | Porto Alegre | 90035-903 | Brazil |
| Instituto do Cancer de Sao Paulo - ICESP ( Site 0206) | São Paulo | 01246-000 | Brazil |
| Tom Baker Cancer Centre ( Site 0503) | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute ( Site 0502) | Edmonton | Alberta | T6G 1Z2 | Canada |
| CancerCare Manitoba ( Site 0500) | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Juravinski Cancer Center ( Site 0508) | Hamilton | Ontario | L8V 5C2 | Canada |
| The Ottawa Hospital - Cancer Care ( Site 0501) | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre ( Site 0505) | Toronto | Ontario | M5G 2M9 | Canada |
| CISSS de la Monteregie-Centre ( Site 0504) | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Jewish General Hospital ( Site 0507) | Montreal | Quebec | H3T 1E2 | Canada |
| Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003) | Concepción | 4070038 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 1001) | Santiago | 7620002 | Chile |
| Hospital Clinico Universidad de Chile ( Site 1002) | Santiago | 8380456 | Chile |
| Clinica Alemana de Temuco ( Site 1006) | Temuco | 4810297 | Chile |
| Anhui Provincial Hospital ( Site 0106) | Hefei | Anhui | 230036 | China |
| The First Affiliated Hospital of Anhui Medical University ( Site 0112) | Hefei | Anhui | 230088 | China |
| Peking Union Medical College Hospital ( Site 0123) | Beijing | Beijing Municipality | 100032 | China |
| The First Affiliated Hospital of Xiamen University ( Site 0119) | Xiamen | Fujian | 361000 | China |
| Guangdong General Hospital ( Site 0103) | Guangzhou | Guangdong | 510120 | China |
| The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102) | Harbin | Heilongjiang | 150081 | China |
| Tongji Medical College Huazhong University of Science and Technology ( Site 0109) | Wuhan | Hubei | 430030 | China |
| Hunan Cancer Hospital ( Site 0105) | Changsha | Hunan | 410013 | China |
| PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110) | Nanjing | Jiangsu | 210002 | China |
| Zhongda Hospital Southeast University ( Site 0125) | Nanjing | Jiangsu | 210009 | China |
| Jilin Cancer Hospital ( Site 0101) | Changchun | Jilin | 130012 | China |
| The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120) | Xi'an | Shannxi | 710061 | China |
| Zhejiang Cancer Hospital ( Site 0116) | Hangzhou | Zhejiang | 310022 | China |
| Beijing Cancer Hospital ( Site 0100) | Beijing | 100142 | China |
| Fujian Provincial Cancer Hospital ( Site 0104) | Fuzhou | 350014 | China |
| Shanghai Chest Hospital ( Site 0111) | Shanghai | 200030 | China |
| Fudan University Shanghai Cancer Center ( Site 0108) | Shanghai | 200032 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114) | Shanghai | 200127 | China |
| Henan Cancer Hospital ( Site 0107) | Zhengzhou | 450008 | China |
| Rodrigo Botero SAS ( Site 2703) | Medellín | Antioquia | 050030 | Colombia |
| Oncomedica S.A. ( Site 2701) | Montería | Departamento de Córdoba | 230018 | Colombia |
| CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600) | San José | 10103 | Costa Rica |
| Policlinico San Bosco ( Site 2602) | San José | 10103 | Costa Rica |
| ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601) | San José | 10108 | Costa Rica |
| Rigshospitalet ( Site 2301) | Copenhagen | 2100 | Denmark |
| Odense Universitetshospital ( Site 2300) | Odense | 5000 | Denmark |
| Centre Leon Berard ( Site 0307) | Lyon | Cedex 8 | 69373 | France |
| CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305) | Brest | 29200 | France |
| Centre Francois Baclesse ( Site 0310) | Caen | 14076 | France |
| Centre Oscar Lambret ( Site 0304) | Lille | 59020 | France |
| Institut du Cancer de Montpellier ( Site 0306) | Montpellier | 34298 | France |
| CHU de Nantes - Hotel Dieu ( Site 0303) | Nantes | 44093 | France |
| Institut Mutualiste Montsouris ( Site 0300) | Paris | 75014 | France |
| CHU de Saint Etienne Hopital Nord ( Site 0309) | Saint-Etienne | 42055 | France |
| Staedtisches Klinikum Dresden ( Site 1507) | Dresden | 01067 | Germany |
| Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502) | Hamburg | 20249 | Germany |
| Universitaetsklinikum Leipzig ( Site 1501) | Leipzig | 04103 | Germany |
| Klinikum Ludwigsburg ( Site 1509) | Ludwigsburg | 71640 | Germany |
| Universitatsklinikum Mannheim GmbH ( Site 1504) | Mannheim | 68167 | Germany |
| Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508) | Mönchengladbach | 41063 | Germany |
| III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506) | München | 81675 | Germany |
| Centro de Investigacion Oncologica ( Site 1402) | Guatemala City | 01010 | Guatemala |
| Oncomedica ( Site 1400) | Guatemala City | 01010 | Guatemala |
| Grupo Medico Angeles ( Site 1401) | Guatemala City | 01015 | Guatemala |
| Medi-K Cayala ( Site 1404) | Guatemala City | 01016 | Guatemala |
| Centro Regional de Sub Especialidades Medicas SA ( Site 1403) | Quetzaltenango | 09001 | Guatemala |
| Humanity Health Research Centre ( Site 1603) | Hong Kong | Hong Kong |
| Pamela Youde Nethersole Eastern Hospital ( Site 1601) | Hong Kong | Hong Kong |
| Princess Margaret Hospital. ( Site 1602) | Hong Kong | Hong Kong |
| Queen Mary Hospital ( Site 1600) | Hong Kong | Hong Kong |
| Aichi Cancer Center Hospital ( Site 0902) | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East ( Site 0908) | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 0901) | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido University Hospital ( Site 0916) | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Cancer Center ( Site 0913) | Akashi | Hyōgo | 673-8558 | Japan |
| Kobe City Medical Center General Hospital ( Site 0929) | Kobe | Hyōgo | 650-0047 | Japan |
| Ibaraki Prefectural Central Hospital ( Site 0918) | Kasama | Ibaraki | 309-1793 | Japan |
| University of Tsukuba Hospital ( Site 0910) | Tsukuba | Ibaraki | 305-8576 | Japan |
| Kagawa University Hospital ( Site 0915) | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| St. Marianna University School of Medicine Hospital ( Site 0903) | Kawasaki | Kanagawa | 216-8511 | Japan |
| Kanagawa Cancer Center ( Site 0921) | Yokohama | Kanagawa | 241-8515 | Japan |
| Oita University Hospital ( Site 0930) | Yufu | Oita Prefecture | 879-5593 | Japan |
| Kansai Medical University Hospital ( Site 0931) | Hirakata | Osaka | 573-1191 | Japan |
| Kindai University Hospital ( Site 0917) | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital ( Site 0911) | Suita | Osaka | 565-0871 | Japan |
| Osaka Medical College Hospital ( Site 0925) | Takatsuki | Osaka | 569-8686 | Japan |
| Saitama Cancer Center ( Site 0926) | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center Hospital and Research Institute ( Site 0914) | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Kyorin University Hospital ( Site 0905) | Mitaka | Tokyo | 181-8611 | Japan |
| Chiba University Hospital ( Site 0909) | Chiba | 260-8677 | Japan |
| Chiba Cancer Center ( Site 0900) | Chiba | 260-8717 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 0906) | Fukuoka | 811-1395 | Japan |
| Kyushu University Hospital ( Site 0922) | Fukuoka | 812-8582 | Japan |
| Gifu University Hospital ( Site 0920) | Gifu | 501-1194 | Japan |
| Kumamoto University Hospital ( Site 0919) | Kumamoto | 860-8556 | Japan |
| Niigata Cancer Center Hospital ( Site 0924) | Niigata | 951-8566 | Japan |
| Osaka International Cancer Institute ( Site 0923) | Osaka | 541-8567 | Japan |
| Osaka General Medical Center ( Site 0912) | Osaka | 558-8558 | Japan |
| National Cancer Center Hospital ( Site 0907) | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR ( Site 0904) | Tokyo | 135-8550 | Japan |
| Keio University Hospital ( Site 0927) | Tokyo | 160-8582 | Japan |
| Beacon International Specialist Centre ( Site 1803) | Petaling Jaya | Selangor | 46050 | Malaysia |
| Hospital Kuala Lumpur ( Site 1805) | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre ( Site 1802) | Kuala Lumpur | 59100 | Malaysia |
| Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702) | Arequipa | 04000 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701) | Lima | 15033 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas ( Site 1705) | Lima | 15038 | Peru |
| S C Pelican Impex SRL ( Site 2403) | Oradea | Bihor County | 410469 | Romania |
| S.C. Radiotherapy Center Cluj S.R.L ( Site 2407) | Comuna Floresti | Cluj | 407280 | Romania |
| S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404) | Craiova | Dolj | 200347 | Romania |
| S.C.Focus Lab Plus S.R.L ( Site 2401) | Bucharest | Sector 2 | 021389 | Romania |
| S C Oncocenter Oncologie Medicala S R L ( Site 2405) | Timișoara | Timiș County | 300166 | Romania |
| S.C.Gral Medical S.R.L ( Site 2406) | Bucharest | 031422 | Romania |
| Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402) | Constanța | 900591 | Romania |
| SBHCI RCOD of MHC RB ( Site 0407) | Ufa | Bashkortostan Republic | 450054 | Russia |
| Leningrad Regional Oncology Center ( Site 0405) | Saint Petersburg | Vsevolzhsk District | 188663 | Russia |
| National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402) | Moscow | 105203 | Russia |
| N.N. Blokhin NMRCO ( Site 0401) | Moscow | 115478 | Russia |
| Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406) | Saint Petersburg | 197758 | Russia |
| St Petersburg City Clinical Oncology Dispensary ( Site 0409) | Saint Petersburg | 198255 | Russia |
| Tomsk Scientific Research Institute of Oncology ( Site 0403) | Tomsk | 634028 | Russia |
| Cancer Care Langenhoven Drive Oncology Centre ( Site 2501) | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| The Medical Oncology Centre of Rosebank ( Site 2506) | Johannesburg | Gauteng | 2196 | South Africa |
| WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500) | Parktown | Gauteng | 2193 | South Africa |
| The Oncology Centre ( Site 2502) | Durban | KwaZulu-Natal | 4091 | South Africa |
| Cape Town Oncology Trials Pty Ltd ( Site 2508) | Cape Town | Western Cape | 7570 | South Africa |
| Outeniqua Cancercare Oncology Unit ( Site 2504) | George | Western Cape | 6530 | South Africa |
| Clinton Oncology Centre ( Site 2505) | Alberton | 1448 | South Africa |
| National Cancer Center ( Site 1304) | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital ( Site 1305) | Hwasun Gun | Jeollanam-do | 58128 | South Korea |
| Seoul National University Cancer Hospital ( Site 1301) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 1302) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 1303) | Seoul | 05505 | South Korea |
| Samsung Medical Center ( Site 1300) | Seoul | 06351 | South Korea |
| Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701) | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Central de Asturias ( Site 0708) | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitari Vall d Hebron ( Site 0702) | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia ( Site 0706) | Córdoba | 14004 | Spain |
| Hospital Ramon y Cajal ( Site 0703) | Madrid | 28034 | Spain |
| Hospital Universitario La Paz ( Site 0700) | Madrid | 28046 | Spain |
| Complejo Hospitalario Virgen De La Victoria ( Site 0705) | Málaga | 29010 | Spain |
| Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906) | Kaohsiung City | 833 | Taiwan |
| Taipei Medical University Shuang Ho Hospital ( Site 1908) | New Taipei City | 235 | Taiwan |
| China Medical University Hospital ( Site 1904) | Taichung | 404 | Taiwan |
| Kuang Tien General Hospital ( Site 1909) | Taichung | 43303 | Taiwan |
| National Cheng Kung University Hospital ( Site 1905) | Tainan | 704 | Taiwan |
| Chi Mei Medical Center Liuying ( Site 1907) | Tainan | 736 | Taiwan |
| National Taiwan University Hospital ( Site 1900) | Taipei | 10002 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902) | Taipei | 11259 | Taiwan |
| Chang Gung Medical Foundation. Linkou ( Site 1903) | Taoyuan | 333 | Taiwan |
| Bumrungrad International Hospital ( Site 2203) | Bangkok | 10110 | Thailand |
| Chulalongkorn Hospital ( Site 2201) | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital. ( Site 2202) | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital ( Site 2205) | Bangkok | 10400 | Thailand |
| Songklanagarind Hospital ( Site 2204) | Songkhla | 90110 | Thailand |
| Adana Sehir Hastanesi ( Site 0802) | Adana | 01370 | Turkey (Türkiye) |
| Ankara Sehir Hastanesi ( Site 0808) | Ankara | 06800 | Turkey (Türkiye) |
| Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807) | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804) | Istanbul | 34098 | Turkey (Türkiye) |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801) | Istanbul | 34899 | Turkey (Türkiye) |
| Medical Park Izmir Hastanesi ( Site 0800) | Izmir | 35575 | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803) | Malatya | 44280 | Turkey (Türkiye) |
| Lothian University Hospitals NHS Trust ( Site 1101) | Edinburgh | Mid Lothian | EH4 2XU | United Kingdom |
| St Luke's Cancer Centre ( Site 1102) | Guildford | GU2 7XX | United Kingdom |
| The Christie NHS Foundation Trust ( Site 1100) | Manchester | M20 4BX | United Kingdom |
| Zhang Y, Diez Garcia M, Shah S, Joo S, Valderrama A, Zhang S, Enzinger PC. Analysis of quality-adjusted survival time without symptoms or toxicity for pembrolizumab plus chemotherapy as treatment for previously untreated participants with advanced or metastatic esophageal cancer. Qual Life Res. 2026 Feb 1;35(3):58. doi: 10.1007/s11136-025-04109-4. |
| 38815152 | Derived | Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. Oncologist. 2024 Oct 3;29(10):e1324-e1335. doi: 10.1093/oncolo/oyae087. |
| 38607538 | Derived | Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus. 2024 Jul;21(3):306-318. doi: 10.1007/s10388-024-01053-z. Epub 2024 Apr 12. |
| 37139963 | Derived | Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4. |
| 35668304 | Derived | Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7. |
| 35394255 | Derived | Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8. |
| 34454674 | Derived | Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. |
| 30735435 | Derived | Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8. |
| Plain Language Summary | View source |
| FG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + SOC | Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
| BG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Geographic Region | Participants were stratified according to Geographic Region of enrolling site (Asia versus Rest of World) | Count of Participants | Participants |
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| Histology | Participants were stratified according to baseline Histology (adenocarcinoma versus squamous cell carcinoma) | Count of Participants | Participants |
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| Eastern Cooperative Group Performance Status (ECOG PS) | ECOG PS 0 = Fully active, able to carry on all pre-disease performance without restriction), ECOG PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, ECOG PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. Participants were stratified according to baseline ECOG PS (0 versus 1). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10) | Overall survival 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 is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS ≥10. | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | OS in Participants With ESCC | Overall survival 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 is reported here for all participants of the ITT population (all randomized) who had ESCC. | All randomized participants (ITT population) with ESCC were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Overall survival 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 is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | OS in All Participants | Overall survival 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 is reported here for all participants of the ITT population (all randomized). | All randomized participants (ITT population) were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who had ESCC. | All randomized participants (ITT population) with ESCC were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Primary | PFS Per RECIST 1.1 As Assessed By Investigator in All Participants | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, 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. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized). | All randomized participants (ITT population) were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized). | All randomized participants (ITT population) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 34 months |
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| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC and who were PD-L1 CPS ≥10. | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 34 months |
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| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC. | All randomized participants (ITT population) with ESCC were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 34 months |
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| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10. | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 34 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR. | All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC and were PD-L1 CPS ≥10. | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 who demonstrated a confirmed CR or PR were analyzed were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC. | All randomized participants (ITT population) with ESCC who demonstrated a confirmed CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | 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 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, 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. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and were PD-L1 CPS ≥10. | All randomized participants (ITT population) who were PD-L1 CPS ≥10 and who demonstrated a confirmed CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 34 months |
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| Secondary | Number of Participants With an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did 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 that experienced at least one AE was reported for each treatment arm. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | Count of Participants | Participants | Up to approximately 28 months |
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| Secondary | Number of Participants Discontinuing Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did 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 that discontinued any study drug due to an AE was reported for each treatment arm. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | Count of Participants | Participants | Up to approximately 27 months |
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| Secondary | Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants. | All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC-QLQ-C30 assessment were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC and who were PD-L1 CPS ≥10. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, who had ESCC, and who were PD-L1 CPS ≥10 were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who had ESCC were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who were PD-L1 CPS ≥10. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who were PD-L1 CPS ≥10 were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC QLQ-OES18 assessment were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with ESCC and PD-L1 CPS ≥10 were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with ESCC were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
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| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with PD-L1 CPS ≥10 were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline, Week 18 |
|
Up to approximately 70 months
All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab + SOC | Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. | 331 | 373 | 207 | 370 | 367 | 370 |
| EG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. | 363 | 376 | 204 | 370 | 364 | 370 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Graves' disease | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumatosis | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vascular device occlusion | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Granulomatous liver disease | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral myositis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Product administration error | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal submucosal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Neoplasm swelling | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Apr 11, 2024 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Rest of World |
|
| Squamous Cell Carcinoma |
|
| ECOG PS 1 |
|
| ECOG PS 2 |
|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
| Participants |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
|
|
| Placebo + SOC |
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
|
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
|
|
|
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
| OG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
| OG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
| OG001 |
| Placebo + SOC |
Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|
| OG001 | Placebo + SOC | Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle. |
|
|
|