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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-B83 | Other Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-B83 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.
Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLX475 and pembrolizumab combination therapy | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLX475 | Drug | tablet |
| |
| Pembrolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method. | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Disease Control Rate (DCR) is defined as the proportion of subjects with confirmed best overall response of CR, PR or SD according to RECIST version 1.1. | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
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Inclusion Criteria:
All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma
Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)
Tumor available for biopsy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanllym University Medical Center | Anyang-si | Gyeonggi-do | South Korea | |||
| Seoul National University Bundang Hospital |
Screening will occur from Day -30 to Day -1. Once screening procedures are completed and eligibility is confirmed, subjects will be enrolled for the study and start study treatment. There is no pre-assignment planned.
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| ID | Title | Description |
|---|---|---|
| FG000 | FLX475 and Pembrolizumab Combination Therapy |
FLX475: tablet Pembrolizumab: IV infusion |
| 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 | Yes | No | No | Study Protocol | Dec 6, 2022 | Aug 10, 2025 |
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| Drug |
IV infusion |
|
|
| Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Time to Response (TTR) is defined as the time from the date of first administration of study treatment to first documented Complete Response (CR) or Partial Response (PR). | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Duration of Response (DoR) is measured from the date of the first observation of tumor response (Complete Response (CR) or Partial Response (PR), whichever occurs first) to the date of disease progression or death for the subject with an objected response. | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Progression-free Survival (PFS) is defined as the time from the date of first administration of study treatment to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first. | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Overall Survival (OS) is defined as the duration of time from the treatment start date to time to death from any cause. If subjects survive at the time of analysis, the subject will be censored at the last date of survival confirmed. | From baseline (Cycle 1 Day 1 prior to administration of the first study dose) until death from any cause. |
| Seongnam-si |
| Gyeonggi-do |
| South Korea |
| The Catholic University of Korea St. Vincent Hospital | Suwon | Gyeonggi-do | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
|
All subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | FLX475 and Pembrolizumab Combination Therapy |
FLX475: tablet Pembrolizumab: IV infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for age were reported separately for each cohort (10 patients each). | Median | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for sex were reported separately for each cohort (10 patients each). | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for race/ethnicity were reported separately for each cohort (10 patients each). | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Height (cm) | This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for baseline height were reported separately for each cohort (10 patients each). | Mean | Standard Deviation | cm |
| ||||||||||||||||
| BMI (kg/m2) | This clinical trial was designed with two separate cohorts. The overall baseline population was based on the total treated set across both cohorts, while the results for BMI were reported separately for each cohort (10 patients each). | Mean | Standard Deviation | kg/m2 |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method. | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Number | 95% Confidence Interval | percentage of participants | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Disease Control Rate (DCR) is defined as the proportion of subjects with confirmed best overall response of CR, PR or SD according to RECIST version 1.1. | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Number | 95% Confidence Interval | percentage of participants | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Time to Response (TTR) is defined as the time from the date of first administration of study treatment to first documented Complete Response (CR) or Partial Response (PR). | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Median | 95% Confidence Interval | months | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Duration of Response (DoR) is measured from the date of the first observation of tumor response (Complete Response (CR) or Partial Response (PR), whichever occurs first) to the date of disease progression or death for the subject with an objected response. | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Median | 95% Confidence Interval | months | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Progression-free Survival (PFS) is defined as the time from the date of first administration of study treatment to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first. | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Median | 95% Confidence Interval | months | Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab | The Overall Survival (OS) is defined as the duration of time from the treatment start date to time to death from any cause. If subjects survive at the time of analysis, the subject will be censored at the last date of survival confirmed. | The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population. | Posted | Median | 95% Confidence Interval | months | From baseline (Cycle 1 Day 1 prior to administration of the first study dose) until death from any cause. |
|
Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months.
Safety endpoints were analyzed using the Treated Set. All AEs were coded using MedDRA Version 26.1 and graded using NCI-CTCAE Version 5.0. All AE summaries were restricted to treatment-emergent adverse events (TEAEs) only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: EBV Negative / CPI naïve Gastric Cancer | ◦ Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer | 3 | 10 | 2 | 10 | 9 | 10 |
| EG001 | Cohort 2: EBV Positive / CPI naïve Gastric Cancer | ◦ Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer | 4 | 10 | 5 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Internal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Internal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Malignant ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Obstruction gastric | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Localised oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Pleural infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Productive coug | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
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| Immune-mediated adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Retinopathy | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Calculus bladder | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Su (Bobby) Noh | Hanmi Pharm. Co., Ltd. | 82-2-410-9277 | 63forever@hanmi.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2023 | Aug 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Cohort 1 |
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| Cohort 2 |
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| Cohort 1 |
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| Cohort 1 |
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| Cohort 2 |
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