A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI473... | NCT02340975 | Trialant
NCT02340975
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Jun 9, 2020Actual
Enrollment
114Actual
Phase
Phase 1Phase 2
Conditions
Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
MEDI4736 + tremelimumab
MEDI4736 + tremelimumab
MEDI4736
Tremelimumab
MEDI4736+tremelimumab
MEDI4736 + tremelimumab
Countries
United States
Canada
Japan
Singapore
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02340975
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4190C00021
Secondary IDs
Not provided
Brief Title
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Official Title
A Phase 1b/2 Study of MEDI4736 in Combination With Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects With Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 31, 2015Actual
Primary Completion Date
Apr 29, 2019Actual
Completion Date
Apr 29, 2019Actual
First Submitted Date
Jan 14, 2015
First Submission Date that Met QC Criteria
Jan 14, 2015
First Posted Date
Jan 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 27, 2020
Results First Submitted that Met QC Criteria
Apr 27, 2020
Results First Posted Date
May 11, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 2, 2020
Last Update Posted Date
Jun 9, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.
Detailed Description
Not provided
Conditions Module
Conditions
Gastric or Gastroesophageal Junction Adenocarcinoma
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Biological: MEDI4736 + tremelimumab
Phase 2 Arm B-M10 mg/kg (Q2W)
Experimental
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Biological: MEDI4736
Phase 2 Arm C-T10 mg/kg (Q4W)
Experimental
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI4736 + tremelimumab
Biological
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 1b
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b
A DLT was defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period (From first dose of Study drug [Day 1] through 28 days after the administration of MEDI4736 and tremelimumab). The DLTs are: any Grade 4 immune-related adverse event (irAE), any Grade >=3 non-irAE, >= Grade 3 colitis, Grade 3 or 4 noninfectious pneumonitis irrespective of duration, Grade 2 pneumonitis, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN. Immune-related AEs are defined as AEs of an immune nature (ie, inflammatory) in the absence of a clear alternative etiology.
From first dose of Study drug (Day 1) through 28 days after the administration of MEDI4736 and tremelimumab
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response in Phase 1b
OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization of participants or date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female participants
18 years and older
Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
Participants must have received and have progressed, or are refractory to standard regimens
Participants must have at least one lesion amenable to biospy
Exclusion Criteria:
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Previous immunotherapy
Concurrent or prior use of immunosuppressive medication with 14 days
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Biological: MEDI4736 + tremelimumab
MEDI4736 + tremelimumab
Biological
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b
Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b
The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
Baseline (Day 1)
Percentage of Participants With Objective Response (OR) in Phase 2
OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Progression Free Survival at 6 (PFS-6) Month in Phase 2
The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
From Day 1 upto 6 months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Duration of Stable Disease (DSD) in Phase 1b
The DSD was defined as the time from the date of first dose of study treatment for Phase 1b until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b
Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Percentage of Participants With Disease Control at 16 Weeks in Phase 1b
The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
From Day 1 up to 16 weeks
Percentage of Participants With Disease Control at 24 Weeks in Phase 1b
The disease control rate at 24 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
From Day 1 up to 24 weeks
Progression Free Survival at 6 Month in Phase 1b
The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Phase 1b participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
From Day 1 upto 6 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 2
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2
Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2
The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
Baseline (Day 1)
Percentage of Participants With Disease Control at 16 Weeks in Phase 2
The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
From Day 1 up to 16 weeks
Percentage of Participants With Disease Control at 24 Weeks in Phase 2
The disease control rate at 24 weeks was defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
From Day 1 up to 24 weeks
Duration of Response (DoR) in Phase 2
The DoR was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression according to RECIST v1.1 that occurred subsequently after response or death due to any cause, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline. Kaplan Meier method was used to evaluate DoR.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Time to Response (TTR) in Phase 2
TTR: time from date of randomization of participants for Arm A, B, and C or date of first dose of study drug for Arm D and Arm E until first documented OR per RECIST v1.1. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization/date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in SOD of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD; PD: at least 20% increase in SOD of target lesions from smallest sum (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method used to evaluate TTR.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Duration of Stable Disease in Phase 2
The DSD was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5 mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2
Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Progression Free Survival in Phase 2
The PFS was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study treatment for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Progression Free Survival at 9 Month (PFS-9) in Phase 2
The PFS-9 is the 9-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 9 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, C participants or the date of first dose of study drug for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
From Day 1 up to 9 months
Overall Survival (OS) in Phase 2
The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until death due to any cause. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS.
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Overall Survival at 12 Months in Phase 2
The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until 12 months. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS and 95% confidence interval.
From Day 1 up to 12 months
Percentage of Participants With Objective Response With Positive Interferon Gamma (IFN-γ) Gene Expression in Phase 2
Percentage of participants with OR with positive IFN-γ gene expression is reported. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2
Percentage of participants with PFS at 6 month with positive IFN-γ gene expression is reported. The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status
Percentage of participants with objective response in Phase 2 by programmed death-ligand (PD-L1) status is reported. PD-L1 is a protein that may be found on some normal cells and in higher-than-normal amounts on some types of cancer cells. It plays a role in regulating the immune response against some types of cancers and therefore, is the target for some anticancer drugs. PD-L1 status was based on the percentage of tumor cells from baseline tumor tissue samples with PD-L1 membrane staining: PD-L1 high if >= 1% tumor cells (better response), PD-L1 low/neg if < 1% tumor cells (low response).
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
FG002
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
FG003
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
FG0006 subjects
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COMPLETED
FG0000 subjects
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FG0030 subjects
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FG0050 subjects
NOT COMPLETED
FG0006 subjects
FG00127 subjects
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FG00312 subjects
FG00425 subjects
FG00519 subjects
Type
Comment
Reasons
Death
FG0006 subjects
FG00123 subjects
FG00221 subjects
FG0037 subjects
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Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
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FG0033 subjects
FG004
Other
FG0000 subjects
FG0014 subjects
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FG0032 subjects
FG004
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
BG002
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
BG003
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG00127
BG00224
BG00312
BG00425
BG00519
BG006113
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00070.0± 12.7
BG00160.4± 13.5
BG00259.8± 12.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 1b
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG0006
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0006
TESAEs
Title
Measurements
OG0002
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1b
A DLT was defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period (From first dose of Study drug [Day 1] through 28 days after the administration of MEDI4736 and tremelimumab). The DLTs are: any Grade 4 immune-related adverse event (irAE), any Grade >=3 non-irAE, >= Grade 3 colitis, Grade 3 or 4 noninfectious pneumonitis irrespective of duration, Grade 2 pneumonitis, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN. Immune-related AEs are defined as AEs of an immune nature (ie, inflammatory) in the absence of a clear alternative etiology.
Dose limiting toxicity (DLT) evaluable population included all participants in the Phase 1b who received the Study drug and completed safety follow-up through the DLT evaluation period or experience a DLT during the DLT evaluation period (From first dose of Study drug [Day 1] through 28 days after the administration of MEDI4736 and tremelimumab).
Posted
Count of Participants
Participants
From first dose of Study drug (Day 1) through 28 days after the administration of MEDI4736 and tremelimumab
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Primary
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 1b
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG000
Primary
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 1b
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
Primary
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 1b
Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG000
Primary
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 1b
The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Primary
Percentage of Participants With Objective Response (OR) in Phase 2
OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Primary
Progression Free Survival at 6 (PFS-6) Month in Phase 2
The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Secondary
Percentage of Participants With Objective Response in Phase 1b
OR: best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per RECIST v1.1. BOR: best response (CR, PR, stable disease [SD], progressive disease [PD], and not evaluable) among all overall responses recorded from date of randomization of participants or date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Duration of Stable Disease (DSD) in Phase 1b
The DSD was defined as the time from the date of first dose of study treatment for Phase 1b until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. DSD was analyzed for participants with SD.
Posted
Median
Full Range
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 1b
Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Median
Full Range
mm
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 months post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Secondary
Percentage of Participants With Disease Control at 16 Weeks in Phase 1b
The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Secondary
Percentage of Participants With Disease Control at 24 Weeks in Phase 1b
The disease control rate at 24 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of first dose of study drug. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Secondary
Progression Free Survival at 6 Month in Phase 1b
The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Phase 1b participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Phase 2
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Phase 2
Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Secondary
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Phase 2
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure [BP], pulse rate [or pulse oximetry at screening], and respiratory rate). Abnormal physical examinations are defined as any abnormal impact on measurements of height and weight.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Secondary
Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Phase 2
Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, PR, RR, QRS and QT intervals from the primary lead of the digital 12-lead ECG.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Secondary
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline in Phase 2
The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. ECOG Performance Status Scorings are: 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2= ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. The baseline performance status of participants is presented.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Percentage of Participants With Disease Control at 16 Weeks in Phase 2
The disease control rate at 16 weeks was defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 110 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Percentage of Participants With Disease Control at 24 Weeks in Phase 2
The disease control rate at 24 weeks was defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or had SD with duration of SD for a minimum duration of 166 days, following the date of randomization for Arm A, B, and C participants and the date of first dose of study drug for Arm D and E participants. The DC was defined as a BOR of confirmed CR, confirmed PR or SD per RECIST v1.1. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Duration of Response (DoR) in Phase 2
The DoR was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression according to RECIST v1.1 that occurred subsequently after response or death due to any cause, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline. Kaplan Meier method was used to evaluate DoR.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with OR were analyzed for the specified outcome measure.
Posted
Median
Full Range
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Time to Response (TTR) in Phase 2
TTR: time from date of randomization of participants for Arm A, B, and C or date of first dose of study drug for Arm D and Arm E until first documented OR per RECIST v1.1. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization/date of first dose of study drug until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in SOD of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD; PD: at least 20% increase in SOD of target lesions from smallest sum (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method used to evaluate TTR.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with OR were analyzed for the specified outcome measure.
Posted
Median
Full Range
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Duration of Stable Disease in Phase 2
The DSD was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until the first date of documented PD (per RECIST v1.1), or death due to any cause, whichever occurred first. PD is at least a 20% increase in sum of diameters of target lesions from smallest sum on study (at least 5 mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy. Kaplan Meier method was used to evaluate DSD.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. DSD was analyzed for participants with SD.
Posted
Median
Full Range
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Median Best Percentage Change From Baseline of the Sum of Longest Diameters (SLD) of Target Lesions in Phase 2
Best percentage change from baseline of the SLD of target lesions per RECIST v1.1 was derived as the biggest decease or the smallest increase from baseline on the SLD among all post-baseline disease assessment including unscheduled assessments. Best percent change is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Participants with any reduction in tumor size were analyzed for the specified outcome measure.
Posted
Median
Full Range
mm
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Secondary
Progression Free Survival in Phase 2
The PFS was defined as the time from the date of randomization for Arm A, B, and C participants or the date of first dose of study treatment for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Median
95% Confidence Interval
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Secondary
Progression Free Survival at 9 Month (PFS-9) in Phase 2
The PFS-9 is the 9-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 9 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, C participants or the date of first dose of study drug for Arm D and E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Secondary
Overall Survival (OS) in Phase 2
The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until death due to any cause. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Median
Full Range
Months
From Day 1 up to End of the Treatment (EOT), 90 days post-EOT, every 3 months (Q3M) after Day 90 post-EOT up to 12 month post-EOT, and every 6 months after month 12 post-EOT (approximately up to 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
Secondary
Overall Survival at 12 Months in Phase 2
The OS was defined as the time from date of randomization for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants until 12 months. OS was censored at last known alive date. Kaplan Meier method was used to evaluate OS. Kaplan Meier method was used to evaluate OS and 95% confidence interval.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Secondary
Percentage of Participants With Objective Response With Positive Interferon Gamma (IFN-γ) Gene Expression in Phase 2
Percentage of participants with OR with positive IFN-γ gene expression is reported. OR: BOR of confirmed CR or PR per RECIST v1.1. BOR: best response (CR, PR, SD, PD, and not evaluable) among all overall responses recorded from date of randomization for Arm A, B, C participants or date of first dose of study drug for Arms D, E participants until progression, or last evaluable disease assessment or discontinuation from the study, whichever occurred first. CR: disappearance of all target/non-target lesions; PR: at least 30% decrease in sum of diameters (SOD) of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD from smallest SOD on study; PD: at least 20% increase in SOD of target lesions from smallest sum on study (at least 5mm), appearance of one or more new lesions, substantial worsening in non-target disease, increase in tumor burden leading to discontinuation of therapy.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percenatge of Participants
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Percentage of Participants With Progression Free Survival (PFS) at 6 Month With Positive IFN-γ Gene Expression in Phase 2
Percentage of participants with PFS at 6 month with positive IFN-γ gene expression is reported. The PFS-6 is the 6-month progression-free survival rate, which was the percentage of participants who were progression free and alive at 6 months. PFS was defined as the time from the date of first dose of study drug for Arm A, B, and C participants or the date of first dose of study drug for Arm D and Arm E participants to the earlier of the dates of the first objective documentation of radiographic disease progression (per RECIST v1.1) or death due to any cause. PFS was censored at the date of their last evaluable tumor assessment. Kaplan Meier method was used to evaluate PFS-6.
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received. Only those participants were analyzed who were at risk at 6 months.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Secondary
Percentage of Participants With Objective Response in Phase 2 by Programmed Death-ligand (PD-L1) Status
Percentage of participants with objective response in Phase 2 by programmed death-ligand (PD-L1) status is reported. PD-L1 is a protein that may be found on some normal cells and in higher-than-normal amounts on some types of cancer cells. It plays a role in regulating the immune response against some types of cancers and therefore, is the target for some anticancer drugs. PD-L1 status was based on the percentage of tumor cells from baseline tumor tissue samples with PD-L1 membrane staining: PD-L1 high if >= 1% tumor cells (better response), PD-L1 low/neg if < 1% tumor cells (low response).
As-treated population included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 through Day 30 post EOT (approximately 4 years and one month)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Time Frame
Day 1 up to 90 days after the last dose (approximately 4 years and one month)
Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma received intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
23
27
14
27
27
27
EG002
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
21
24
16
24
22
24
EG003
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
13
19
12
19
18
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG0030 events0 affected12 at risk
EG0040 events0 affected25 at risk
EG0052 events1 affected19 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0022 events1 affected24 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
General physical health deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Peripheral swelling
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0023 events2 affected24 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Septic shock
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Transaminases increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Renal disorder
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events2 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Embolism
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG00116 events9 affected27 at risk
EG0026 events3 affected24 at risk
EG0038 events3 affected12 at risk
EG00413 events8 affected25 at risk
EG0056 events4 affected19 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Endocrine disorder
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Glaucoma
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0023 events3 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 events2 affected6 at risk
EG0017 events6 affected27 at risk
EG0023 events3 affected24 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 events2 affected6 at risk
EG00110 events9 affected27 at risk
EG0026 events5 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG00112 events9 affected27 at risk
EG0024 events3 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00120 events2 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 events3 affected6 at risk
EG00111 events7 affected27 at risk
EG0026 events5 affected24 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0017 events3 affected27 at risk
EG0023 events3 affected24 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events2 affected27 at risk
EG0026 events6 affected24 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0003 events3 affected6 at risk
EG00131 events11 affected27 at risk
EG0026 events6 affected24 at risk
EG003
Gait disturbance
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Influenza like illness
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Localised oedema
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Malaise
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Medical device site pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Oedema
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0017 events6 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0017 events5 affected27 at risk
EG0027 events6 affected24 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Torus fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0025 events1 affected24 at risk
EG003
Amylase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events2 affected27 at risk
EG0028 events2 affected24 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Blood albumin decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0024 events2 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events1 affected24 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
International normalised ratio increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0019 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00113 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Platelet count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tri-iodothyronine free decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected27 at risk
EG0024 events4 affected24 at risk
EG003
Weight increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
White blood cell count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00128 events10 affected27 at risk
EG0029 events8 affected24 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00114 events7 affected27 at risk
EG0023 events1 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00111 events4 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events1 affected27 at risk
EG0023 events3 affected24 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected27 at risk
EG0023 events3 affected24 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 events2 affected6 at risk
EG0018 events5 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0024 events2 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00114 events6 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00110 events3 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Aphonia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 events1 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Agitation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Delirium
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00110 events7 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Genital erosion
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0016 events6 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 events2 affected6 at risk
EG00115 events10 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected24 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Lung hyperinflation
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG00121 events3 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 events2 affected6 at risk
EG0018 events5 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events5 affected27 at risk
EG0022 events2 affected24 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00011.1(2.4 to 29.2)
OG0010(0.0 to 14.2)
OG0028.3(0.2 to 38.5)
OG0034.0(0.1 to 20.4)
OG00415.8(3.4 to 39.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.2376
Mean Difference (Net)
11.1
2-Sided
95
-0.7
23.0
Other
Comparison
OG000
OG002
Fisher Exact
1.0000
Median Difference (Net)
2.8
2-Sided
95
-16.8
22.4
Other
Comparison
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00012.1(3.1 to 27.9)
OG001NA(NA to NA)No participants were progression free at 6 months.
OG00223.3(3.6 to 52.9)
OG00312.5(3.1 to 28.7)
OG0045.3(0.4 to 21.4)
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 45.9)
Units
Counts
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG0005.4(3.5 to 7.4)
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00017.7(-3.2 to 115.1)
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00033.3(4.3 to 77.7)
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.4 to 64.1)
OG0006
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.8 to 51.7)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00027
OG00123
OG00212
OG00322
OG00418
TESAEs
Title
Measurements
OG00014
OG00116
OG00210
OG003
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0009
OG0013
OG0023
OG0037
OG0044
Lymphocyte count decreased
Title
Measurements
OG0001
OG0011
OG0021
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
International normalised ratio increased
Title
Measurements
OG0003
OG0010
OG0021
OG003
Activated partial thromboplastin time prolonged
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood fibrinogen decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hepatic function abnormal
Title
Measurements
OG0000
OG0011
OG0021
OG003
Alanine aminotransferase increased
Title
Measurements
OG0002
OG0011
OG0022
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0002
OG0012
OG0023
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0012
OG0021
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperthyroidism
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypothyroidism
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood thyroid stimulating hormone increased
Title
Measurements
OG0003
OG0010
OG0020
OG003
Thyroxine free decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Tri-iodothyronine free decreased
Title
Measurements
OG0002
OG0010
OG0020
OG003
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Atrial fibrillation
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
Bradycardia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypertension
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypotension
Title
Measurements
OG0006
OG0013
OG0021
OG003
Hypoxia
Title
Measurements
OG0002
OG0010
OG0021
OG003
Pyrexia
Title
Measurements
OG0005
OG0017
OG0022
OG003
Respiratory distress
Title
Measurements
OG0001
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0003
OG0011
OG0020
OG003
Tachycardia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Weight decreased
Title
Measurements
OG0003
OG0014
OG0021
OG003
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Sinus tachycardia
Title
Measurements
OG0003
OG0011
OG0020
OG0030
OG0040
Angina pectoris
Title
Measurements
OG0001
OG0010
OG0020
OG003
Ventricular tachycardia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Tachycardia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Atrial fibrillation
Title
Measurements
OG0001
OG0011
OG0021
OG003
Cardiac failure congestive
Title
Measurements
OG0001
OG0010
OG0020
OG003
Atrial tachycardia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Bradycardia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Pericardial effusion
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cardiac failure
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
ECOG 0
Title
Measurements
OG0009
OG0019
OG0024
OG00311
OG00411
ECOG 1
Title
Measurements
OG00018
OG00114
OG0028
OG003
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00018.5(6.3 to 38.1)
OG00112.5(2.7 to 32.4)
OG00216.7(2.1 to 48.4)
OG00328.0(12.1 to 49.4)
OG00421.1(6.1 to 45.6)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00011.1(2.4 to 29.2)
OG0010(0.0 to 14.2)
OG00216.7(2.1 to 48.4)
OG00312.0(2.5 to 31.2)
OG00415.8(3.4 to 39.6)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG0003
OG0010
OG0021
OG0031
OG0043
Title
Denominators
Categories
Title
Measurements
OG000NA(2.0 to 22.4)Median was not estimable because insufficient number of participants had events.
OG0024.6(4.6 to 4.6)
OG0037.4(7.4 to 7.4)
OG0043.1(1.9 to 7.4)
OG001
Phase 2 Arm B-M10 mg/kg (Q2W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG0003
OG0010
OG0021
OG0031
OG0043
Title
Denominators
Categories
Title
Measurements
OG0001.9(1.9 to 3.7)
OG0022.7(2.7 to 2.7)
OG0037.2(7.2 to 7.2)
OG0041.8(1.7 to 1.8)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG0004
OG0013
OG0021
OG0036
OG0041
Title
Denominators
Categories
Title
Measurements
OG0003.5(2.8 to 3.7)
OG0013.6(3.5 to 4.3)
OG0027.7(7.7 to 7.7)
OG0034.2(3.5 to 7.2)
OG0043.5(3.5 to 3.5)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00025
OG00117
OG0029
OG00321
OG00417
Title
Denominators
Categories
Title
Measurements
OG0008.00(-86.7 to 123.0)
OG00121.20(-60.0 to 101.2)
OG002-4.00(-61.1 to 67.2)
OG0030.00(-58.4 to 116.2)
OG0043.00(-100.0 to 54.8)
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG0001.8(1.6 to 2.8)
OG0011.6(1.0 to 1.8)
OG0021.7(0.8 to 7.3)
OG0031.8(1.6 to 3.5)
OG0041.8(1.6 to 1.9)
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00012.1(3.1 to 27.9)
OG001NA(NA to NA)No participants were progression free at 9 months.
OG002NA(NA to NA)No participants were progression free at 9 months.
OG0034.2(0.3 to 17.6)
OG0045.3(0.4 to 21.4)
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG0009.2(1.6 to 32.0)
OG0013.4(0.8 to 9.5)
OG0027.7(0.8 to 33.8)
OG00310.7(1.0 to 30.7)
OG0047.0(0.6 to 18.8)
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Units
Counts
Participants
OG00027
OG00124
OG00212
OG00325
OG00419
Title
Denominators
Categories
Title
Measurements
OG00037.0(19.6 to 54.6)
OG001NA(NA to NA)No participants were alive at 12 months.
OG00213.1(0.7 to 43.6)
OG00340.7(20.2 to 60.3)
OG00429.2(10.9 to 50.5)
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG00015.8(3.4 to 39.6)
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG0005.3(0.4 to 21.4)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses).
OG002
Phase 2 Arm C-T10 mg/kg (Q4W)
Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses).
Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).
Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature received IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses).