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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-966 | Other Identifier | MSD | |
| KEYNOTE-966 | Other Identifier | MSD | |
| 195007 | Registry Identifier | JAPIC-CTI |
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In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 (NCT04003636) plus those enrolled during the China extension enrollment period. A total of approximately 158 Chinese participants will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Pembrolizumab + Chemotherapy | Experimental | Participants receive pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stop the initial course of pembrolizumab with stable disease (SD) or better but progress after discontinuation will initiate a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine can be stopped at any time in first or second course due to toxicity or disease progression. |
|
| Arm B: Placebo + Chemotherapy | Placebo Comparator | Participants receive placebo to pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | Pembrolizumab by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis. | Up to approximately 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BICR | PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented. |
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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 |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital ( Site 0140) | Hefei | Anhui | 230001 | China | ||
| Beijing Cancer Hospital ( Site 0138) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42176183 | Derived | Ren Z, Liang T, Gu S, Gou H, Peng C, Pan Y, Song T, Su H, Cao K, Liang H, Ying J, Geng Z, Yu W, Zhao H, Bai Y, Hao C, Mao Y, Li W, Wang L, Li D, Wang W, Li N, Malhotra U, Qin S. First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-966 Study. Adv Ther. 2026 May 23. doi: 10.1007/s12325-026-03578-4. Online ahead of print. | |
| 40154623 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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158 Chinese participants were randomized (global study [NCT04003636; n=112] or to the extension portion [n=46]).
Per protocol, response or progression during the second course treatment was not counted towards efficacy outcome measures, and adverse events during the second course treatment were not counted towards safety outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Pembrolizumab + Chemotherapy | Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with stable disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression. |
| 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 | Jun 16, 2022 |
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| Gemcitabine | Drug | Gemcitabine by IV infusion |
|
|
| Cisplatin | Drug | Cisplatin by IV infusion |
|
|
| Placebo | Drug | Placebo to pembrolizumab by IV infusion |
|
| Up to approximately 29 months |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. | Up to approximately 29 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | 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, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be 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 as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. | Up to approximately 29 months |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs was reported. | Up to approximately 29 months |
| Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who discontinued study intervention (includes any study medication given during the study) due to an AE were reported. | Up to approximately 29 months |
| Beijing |
| Beijing Municipality |
| 100036 |
| China |
| Peking Union Medical College Hospital ( Site 0150) | Beijing | Beijing Municipality | 100730 | China |
| First Affiliated Hospital of The Third Military Medical University ( Site 0130) | Chongqing | Chongqing Municipality | 400038 | China |
| Fujian Provincial Cancer Hospital ( Site 0154) | Fuzhou | Fujian | 350014 | China |
| 900 Hospital of the Joint ( Site 0137) | Fuzhou | Fujian | 350025 | China |
| Guangdong Provincial People s Hospital ( Site 0161) | Guangzhou | Guangdong | 510080 | China |
| Harbin Medical University Cancer Hospital ( Site 0133) | Harbin | Heilongjiang | 610000 | China |
| Hunan Provincial People Hospital ( Site 0142) | Changsha | Hunan | 410005 | China |
| Hunan Cancer Hospital ( Site 0132) | Changsha | Hunan | 410013 | China |
| The Third Xiangya Hospital of Central South University ( Site 0157) | Changsha | Hunan | 410013 | China |
| The 81st Hospital of PLA ( Site 0128) | Nanjing | Jiangsu | 210031 | China |
| The First Hospital of Jilin University ( Site 0131) | Changchun | Jilin | 130021 | China |
| Zhongshan Hospital Fudan University ( Site 0129) | Shanghai | Shanghai Municipality | 200032 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158) | Shanghai | Shanghai Municipality | 200127 | China |
| Fudan University Shanghai Cancer Center ( Site 0160) | Shanghai | Shanghai Municipality | 201315 | China |
| Tangdu Hospital ( Site 0146) | Xi’an | Shanxi | 710038 | China |
| The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145) | Xi’an | Shanxi | 710048 | China |
| West China Hospital of Sichuan University ( Site 0147) | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute & Hospital ( Site 0155) | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital Zhejiang University ( Site 0136) | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital ( Site 0134) | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Yoo C, Ueno M, Klumpen HJ, Kelley RK, Vogel A, Furuse J, Ren Z, Yau T, Chan SL, Ozaka M, Oh SC, Gu S, Park JO, Valle JW, Edeline J, Kim JG, Kamble S, Norquist JM, Yu L, Malhotra U, Finn RS. Health-related quality of life in participants with advanced biliary tract cancer from the randomized phase III KEYNOTE-966 study. J Hepatol. 2025 Sep;83(3):692-700. doi: 10.1016/j.jhep.2025.03.019. Epub 2025 Mar 27. |
| Plain Language Summary | View source |
| FG001 | Arm B: Placebo + Chemotherapy | Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
| Treated |
|
| Participants Who Received Second Course of Pembrolizumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Chinese participants who were randomized to the global study (NCT04003636) or to the extension portion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Pembrolizumab + Chemotherapy | Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with stable disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression. |
| BG001 | Arm B: Placebo + Chemotherapy | Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Geographic Region | Geographic region represents the number of randomized participants enrolled in Asia. | Count of Participants | Participants |
| |||||||||||||||
| Disease Status | All randomized participants were categorized based on disease status as locally advanced or metastatic. | Count of Participants | Participants |
| |||||||||||||||
| Site of Origin | All randomized participants were categorized based on location of tumor as gallbladder or intrahepatic or extrahepatic bile duct cancers. | Count of Participants | Participants |
|
| 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 Survival (OS) | Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BICR | PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | 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, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be 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 as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. | All responders (participants that achieved complete or partial response) | Posted | Median | 95% Confidence Interval | Months | Up to approximately 29 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs was reported. | All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 29 months |
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| Secondary | Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who discontinued study intervention (includes any study medication given during the study) due to an AE were reported. | APaT population, which consisted of all randomized participants who received at least 1 dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 29 months |
|
Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM & AEs were reported separately for second course treatment for Arm A.
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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 | First Course: Arm A: Pembrolizumab + Chemotherapy | Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. | 65 | 75 | 29 | 74 | 73 | 74 |
| EG001 | First Course: Arm B: Placebo + Chemotherapy | Participants received placebo to pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. | 77 | 83 | 29 | 82 | 82 | 82 |
| EG002 | Second Course: Arm A: Pembrolizumab + Chemotherapy | Eligible participants who stopped the initial course of pembrolizumab with stable disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Bile acids increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
The investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Dec 21, 2023 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D001649 | Bile Duct Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum 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 |
|
| Metastatic |
|
| Intrahepatic |
|
| Extrahepatic |
|
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
|
|
|
|
|
|
| OG001 | Arm B: Placebo + Chemotherapy | Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
|
|
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
|
|
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. |
|
|