Back to resultsStudy of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
Primary Purpose
Esophageal Carcinoma, Esophagogastric Junction Carcinoma
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
pembrolizumab
paclitaxel
docetaxel
irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Death-Ligand 2 (PDL2, PD-L2), Gene expression profiling (GEP)
Eligibility Criteria
Inclusion Criteria:
- Histologically- or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ
- Metastatic disease or locally advanced, unresectable disease
- Life expectancy of greater than 3 months
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy
- Can provide either a newly obtained or archival tumor tissue sample for intra-tumoral immune-related testing and for anti-programmed cell death (PD)-1
- Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan
- Adequate organ function
Exclusion Criteria:
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
- Active autoimmune disease that has required systemic treatment in past 2 years
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis (includes past history or current metastasis)
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
- Has had a severe hypersensitivity reaction to treatment with another mAb
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in Merck pembrolizumab (MK-3475) study
- Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers, and in-situ or intra-mucosal pharyngeal cancer
- Received a live vaccine within 30 days of the first dose of study medication
- Known history of Human Immunodeficiency Virus (HIV) infection
- Known history of or is positive for hepatitis B (hepatitis B surface antigen reactive) or known active hepatitis C (hepatitis C virus RNA or hepatitis C antibody is detected)
- History of non-infectious pneumonitis that required steroids or current pneumonitis
- Active infection requiring systemic therapy
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study starting with the screening visit through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan
- Known allergy, hypersensitivity, or contraindication to paclitaxel, docetaxel, or irinotecan or any components used in their preparation
- Experienced weight loss > 10% over approximately 2 months prior to first dose of study therapy
- Has ascites or pleural effusion by physical exam
- Has experienced documented objective radiographic or clinical disease progression during or after receiving more than 1 line of therapy.
Sites / Locations
- Anhui Provincial Hospital ( Site 0708)
- The First Affiliated Hospital of Anhui Medical University ( Site 0707)
- Harbin Medical University Cancer Hospital ( Site 0714)
- Wuhan Tongji Hospital ( Site 0724)
- Hunan Cancer Hospital ( Site 0722)
- Jiangsu Cancer Hospital (Site 0704)
- PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0706)
- The First Hospital Of Jilin University ( Site 0719)
- Jilin Cancer Hospital ( Site 0718)
- Zhejiang Cancer Hospital ( Site 0726)
- Beijing Cancer Hospital ( Site 0700)
- Chinese PLA General Hospital (Site 0703)
- Peking Union Medical College Hospital ( Site 0712)
- Fujian Medical University Union Hospital ( Site 0721)
- Fujian Province Cancer Hospital ( ( Site 0717)
- The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0705)
- Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0720)
- The Affiliated Hospital of Qingdao University ( Site 0709)
- Ruijin Hospital, Shanghai Jiaotong University ( Site 0701)
- Shanghai Chest Hospital ( Site 0727)
- Fudan University Shanghai Cancer Center ( Site 0723)
- Zhongshan Hospital affiliated to Fudan University ( Site 0715)
- Henan Cancer Hospital ( Site 0725)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab
Chemotherapy
Arm Description
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to ~2 years). Participants who complete the first course of up to 35 administrations of pembrolizumab (~2 years) but progress after discontinuation, may be eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
Participants receive Investigator's choice of chemotherapy: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to ~2 years).
Outcomes
Primary Outcome Measures
Overall Survival (OS) in All Participants
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented.
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented.
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus is presented.
Secondary Outcome Measures
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course is presented.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course is presented.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course is presented.
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented.
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus.
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are presented.
Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE for the first pembrolizumab course are presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03933449
Brief Title
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
Official Title
A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan.
The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.
Detailed Description
The China extension study will include participants previously enrolled in China in the global study for MK-3475-181 (NCT02564263) plus those enrolled during the China extension enrollment period.
Per protocol, response/progression or adverse events during the second pembrolizumab course will not be counted towards efficacy outcome measures or safety outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma, Esophagogastric Junction Carcinoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Death-Ligand 2 (PDL2, PD-L2), Gene expression profiling (GEP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to ~2 years). Participants who complete the first course of up to 35 administrations of pembrolizumab (~2 years) but progress after discontinuation, may be eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants receive Investigator's choice of chemotherapy: paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m^2 IV on Day 1 of every 14-day (2-week) cycle (up to ~2 years).
Intervention Type
Biological
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
TAXOTERE®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
CAMPTOSAR®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Overall Survival (OS) in All Participants
Description
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Description
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Description
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Description
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Description
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Description
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
Description
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
Description
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
Description
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Number of Participants Experiencing an Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Title
Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE for the first pembrolizumab course are presented.
Time Frame
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically- or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ
Metastatic disease or locally advanced, unresectable disease
Life expectancy of greater than 3 months
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy
Can provide either a newly obtained or archival tumor tissue sample for intra-tumoral immune-related testing and for anti-programmed cell death (PD)-1
Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan
Adequate organ function
Exclusion Criteria:
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
Active autoimmune disease that has required systemic treatment in past 2 years
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Known central nervous system (CNS) metastases and/or carcinomatous meningitis (includes past history or current metastasis)
Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
Has had a severe hypersensitivity reaction to treatment with another mAb
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or previously participated in Merck pembrolizumab (MK-3475) study
Has a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers, and in-situ or intra-mucosal pharyngeal cancer
Received a live vaccine within 30 days of the first dose of study medication
Known history of Human Immunodeficiency Virus (HIV) infection
Known history of or is positive for hepatitis B (hepatitis B surface antigen reactive) or known active hepatitis C [hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody is detected]
History of non-infectious pneumonitis that required steroids or current pneumonitis
Active infection requiring systemic therapy
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study starting with the screening visit through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan
Known allergy, hypersensitivity, or contraindication to paclitaxel, docetaxel, or irinotecan or any components used in their preparation
Experienced weight loss > 10% over ~2 months prior to first dose of study therapy
Has ascites or pleural effusion by physical exam
Has experienced documented objective radiographic or clinical disease progression during or after receiving more than 1 line of therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Hospital ( Site 0708)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University ( Site 0707)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 0714)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Wuhan Tongji Hospital ( Site 0724)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0722)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Cancer Hospital (Site 0704)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0706)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
The First Hospital Of Jilin University ( Site 0719)
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital ( Site 0718)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0726)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0700)
City
Beijing
ZIP/Postal Code
100042
Country
China
Facility Name
Chinese PLA General Hospital (Site 0703)
City
Beijing
ZIP/Postal Code
100042
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0712)
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Medical University Union Hospital ( Site 0721)
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Province Cancer Hospital ( ( Site 0717)
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0705)
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0720)
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
The Affiliated Hospital of Qingdao University ( Site 0709)
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University ( Site 0701)
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai Chest Hospital ( Site 0727)
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 0723)
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital affiliated to Fudan University ( Site 0715)
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Henan Cancer Hospital ( Site 0725)
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34973513
Citation
Cao Y, Qin S, Luo S, Li Z, Cheng Y, Fan Y, Sun Y, Yin X, Yuan X, Li W, Liu T, Hsu CH, Lin X, Kim SB, Kojima T, Zhang J, Lee SH, Bai Y, Muro K, Doi T, Bai C, Gu K, Pan HM, Bai L, Yang JW, Cui Y, Lu W, Chen J. Pembrolizumab versus chemotherapy for patients with esophageal squamous cell carcinoma enrolled in the randomized KEYNOTE-181 trial in Asia. ESMO Open. 2022 Feb;7(1):100341. doi: 10.1016/j.esmoop.2021.100341. Epub 2021 Dec 29.
Results Reference
result
Links:
URL
http://merckoncologyclinicaltrials.com/
Description
Merck Oncology Clinical Trial Information
Learn more about this trial
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
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