Safety Study of Enoblituzumab (MGA271) in Combination Wit... | NCT02475213 | Trialant
NCT02475213
Sponsor
MacroGenics
Status
Completed
Last Update Posted
Aug 11, 2025Actual
Enrollment
146Actual
Phase
Phase 1
Conditions
Melanoma
Head and Neck Cancer
Non Small Cell Lung Cancer
Urothelial Carcinoma
Interventions
Enoblituzumab Schedule 1
Pembrolizumab
Enoblituzumab Schedule 2
retifanlimab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02475213
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CP-MGA271-03
Secondary IDs
Not provided
Brief Title
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
Official Title
A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab and in Combination With MGA012 in Patients With Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers
Acronym
Not provided
Organization
MacroGenicsINDUSTRY
Status Module
Record Verification Date
Aug 2025
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
Jul 2015Actual
Primary Completion Date
Aug 18, 2021Actual
Completion Date
Aug 18, 2021Actual
First Submitted Date
Jun 16, 2015
First Submission Date that Met QC Criteria
Jun 16, 2015
First Posted Date
Jun 18, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 14, 2023
Results First Submitted that Met QC Criteria
Aug 4, 2025
Results First Posted Date
Aug 11, 2025Actual
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
Aug 4, 2025
Last Update Posted Date
Aug 11, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MacroGenicsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.
Detailed Description
Not provided
Conditions Module
Conditions
Melanoma
Head and Neck Cancer
Non Small Cell Lung Cancer
Urothelial Carcinoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
146Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
Enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Cohort 2
Experimental
Enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Cohort 3
Experimental
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Cohort 4
Experimental
Enoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks
Biological: Enoblituzumab Schedule 2
Biological: retifanlimab
Melanoma Cohort
Experimental
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Enoblituzumab Schedule 1
Biological
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Cohort 1
Cohort 2
Cohort 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Study Day 1-42, for Cohorts 1-4.
Secondary Outcomes
Measure
Description
Time Frame
Mean Maximum Concentration of Enoblituzumab
The highest measured concentration of enoblizuzumab in the bloodstream.
Baseline, 1, 4, 24, and 72 hours after the first dose.
Mean Trough Concentration of Enoblituzumab
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, triple negative breast cancer, renal clear cell cancer, melanoma, squamous cell cancer of the head and neck, or non-small cell lung cancer.
Participants on the melanoma cohort must have progressed on or after at least one anti-PD-L1 or anti- PD-1 containing therapy.
Participants on the SCCHN cohort must have progressed on or after platinum-based systemic therapy
Participants on the NSCLC cohort must have progressed on or after first line systemic therapy
Participants on the urothelial cancer cohort must have received at least one platinum-containing regimen and have progressed on or after an anti-PD-L1 or anti-PD-1 containing therapy
Measurable disease per RECIST 1.1 criteria
Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
Acceptable laboratory parameters and adequate organ reserve.
Exclusion Criteria:
Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
Patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
History of allogeneic bone marrow, stem cell, or solid organ transplant
Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
Trauma or major surgery within 4 weeks of first study drug administration
History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or pembrolizumab.
Aggarwal C, Prawira A, Antonia S, Rahma O, Tolcher A, Cohen RB, Lou Y, Hauke R, Vogelzang N, P Zandberg D, Kalebasty AR, Atkinson V, Adjei AA, Seetharam M, Birnbaum A, Weickhardt A, Ganju V, Joshua AM, Cavallo R, Peng L, Zhang X, Kaul S, Baughman J, Bonvini E, Moore PA, Goldberg SM, Arnaldez FI, Ferris RL, Lakhani NJ. Dual checkpoint targeting of B7-H3 and PD-1 with enoblituzumab and pembrolizumab in advanced solid tumors: interim results from a multicenter phase I/II trial. J Immunother Cancer. 2022 Apr;10(4):e004424. doi: 10.1136/jitc-2021-004424.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 26, 2020
Sep 28, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Urothelial Cancer Cohort
Experimental
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Non-small Cell Cancer (NSCLC) Cohort
Experimental
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Squamous Cell Cancer of Head and Neck (SCCHN) Cohort
Experimental
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Biological: Enoblituzumab Schedule 1
Biological: Pembrolizumab
Melanoma Cohort
Non-small Cell Cancer (NSCLC) Cohort
Squamous Cell Cancer of Head and Neck (SCCHN) Cohort
Urothelial Cancer Cohort
MGA271
Pembrolizumab
Biological
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Cohort 1
Cohort 2
Cohort 3
Melanoma Cohort
Non-small Cell Cancer (NSCLC) Cohort
Squamous Cell Cancer of Head and Neck (SCCHN) Cohort
Urothelial Cancer Cohort
Keytruda
Enoblituzumab Schedule 2
Biological
Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
Cohort 4
MGA271
retifanlimab
Biological
Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
Cohort 4
INCMGA00012
MGA012
Trough concentration is the concentration measured before the a subsequent dose of enoblituzumab.
MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
At baseline, and Day 7.
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
AUC is the total body exposure to enoblituzumab MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Clearance of Enoblituzumab
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream
At baseline, 1, 4, 24, and 72 and Day 7.
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
At baseline, 1, 4, 24, and 72 and Day 7.
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA)
Every 3 weeks throughout the study, average duration 13 months.
Number of Participants That Develop Retifanlimab ADA
Every 3 weeks throughout the study, average duration 13 months.
Objective Response Rate
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab RECIST 1.1 criteria.
Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
ORR Using Immune-related (ir) RECIST Criteria
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab using irRECIST 1.1 criteria.
Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
Best Overall Response (RECIST 1.1)
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Best Overall Response (irRECIST 1.1)
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.
Minimum and Maximum DoR Per RECIST 1.1
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Progression-free Survival (PFS) Using RECIST 1.1
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median PFS Using irRECIST 1.1 Criteria
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Overall Survival
The time from the first infusion of pembrolizumab or retifanlimab until death from any cause.
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Newark
Delaware
19713
United States
Mayo Clinic - FL
Jacksonville
Florida
32224
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Norton Cancer Institute Research Program
Louisville
Kentucky
40202
United States
University of Maryland Greenbaum Cancer Center
Baltimore
Maryland
21201
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
South Texas Accelerated Research Therapeutics, LLC - Midwest
Grand Rapids
Michigan
49503
United States
Mayo Clinic - MN
Rochester
Minnesota
55905
United States
Nebraska Cancer Specialists
Omaha
Nebraska
68130
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Columbia University Medical Center
New York
New York
10032
United States
Gabrail Cancer Institute
Canton
Ohio
44718
United States
Hospital of the University of Pennsylvania/Abramson Cancer Center
Philadelphia
Pennsylvania
19104
United States
University of Pittsburg
Pittsburgh
Pennsylvania
15232
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
Greenville Health System
Greenville
South Carolina
29605
United States
Mary Crowley Cancer Research Center
Dallas
Texas
75230
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio
Texas
78229
United States
FG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG003
Melanoma Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG004
Urothelial Cancer Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG005
NSCLC Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG006
SCCHN Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
FG007
Cohort 4
enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every 3 weeks for up to 17 doses.
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG00317 subjects
FG00421 subjects
FG00540 subjects
FG00644 subjects
FG00712 subjects
Safety Population
Includes all participants receiving at least 1 dose of enoblituzumab.
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG00317 subjects
FG00421 subjects
FG00540 subjects
FG00643 subjects
FG00712 subjects
PK Population
Includes all participants where PK samples could be analyzed.
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG00317 subjects
FG00421 subjects
FG00539 subjects
FG00642 subjects
FG00712 subjects
Response Evaluable Population
Includes all participants with pre-dose tumor assessment and at least 1 post-dose tumor assessment.
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG00315 subjects
FG00417 subjects
FG00534 subjects
FG00635 subjects
FG00711 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0053 subjects
FG0061 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG00316 subjects
FG00420 subjects
FG00537 subjects
FG00643 subjects
FG00712 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0054 subjects
FG0066 subjects
FG0072 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG00313 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG003
Melanoma Expansion
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG004
Urothelial Cancer Expansion
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG005
NSCLC Expansion
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG006
SCCHN Expansion
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
BG007
Cohort 4
enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses..
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0013
BG0023
BG00317
BG00421
BG00540
BG00643
BG00712
BG008145
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
BG00064.0± 7.85
BG00141.7± 25.38
BG00274.7± 14.64
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG0013
BG002
ECOG Performance Status
The ECOG Performance Status describes patients level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). Lower scores indicate a more self-sufficient level of functioning.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
ECOG 0
BG0002
BG001
Height
Mean
Standard Deviation
Centimeters
Title
Denominators
Categories
Title
Measurements
BG000164.34± 10.12
BG001168.5± 6.44
BG002
Weight
Mean
Standard Deviation
Kilograms
Title
Denominators
Categories
Title
Measurements
BG00073.2± 8.67
BG00163.1± 16.14
BG002
B7H3 immunohistochemistry status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Positive
BG0004
BG0011
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 Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Participants in Cohorts 1-4 are evaluable for DLT during the first 42 days of treatment.
Posted
Count of Participants
Participants
Study Day 1-42, for Cohorts 1-4.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG003
Cohort 4
enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.
Units
Counts
Participants
OG0006
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG003
Secondary
Mean Maximum Concentration of Enoblituzumab
The highest measured concentration of enoblizuzumab in the bloodstream.
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
mcg/mL
Baseline, 1, 4, 24, and 72 hours after the first dose.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG003
Cohort 4
Secondary
Mean Trough Concentration of Enoblituzumab
Trough concentration is the concentration measured before the a subsequent dose of enoblituzumab.
MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
mcg/mL
At baseline, and Day 7.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
Secondary
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
AUC is the total body exposure to enoblituzumab MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
mcg/mL*day
At baseline, 1, 4, 24, 72 hours, and Day 7.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
Secondary
Mean Clearance of Enoblituzumab
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
liters per day
At baseline, 1, 4, 24, 72 hours, and Day 7.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG003
Cohort 4
Secondary
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
liters
At baseline, 1, 4, 24, and 72 and Day 7.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
Secondary
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. PK parameters are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Mean
Standard Deviation
days
At baseline, 1, 4, 24, and 72 and Day 7.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
Secondary
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA)
All participants who received at least one dose of enoblituzumab and have at least one ADA sample sufficient for analysis. ADA samples are analyzed by the dose received. Participants in Cohort 3 and the Expansion Cohorts were combined since all participants were dosed at 15 mg/kg.
Posted
Count of Participants
Participants
Every 3 weeks throughout the study, average duration 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG002
Cohort 3 and Expansion Cohorts
enoblituzumab 15 mg/kg IV weekly for up to 51 doses plus pembrolizumab 2 mg/kg every 3 weeks for up to 17 doses
OG003
Cohort 4
enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.
Secondary
Number of Participants That Develop Retifanlimab ADA
All participants who received at least one dose of retifanlimab and have at least one ADA sample sufficient for analysis.
Posted
Count of Participants
Participants
Every 3 weeks throughout the study, average duration 13 months.
ID
Title
Description
OG000
Cohort 4
enoblituzumab 15 mg/kg IV and retifanlimab 375 mg IV every three weeks for up to 17 doses.
Units
Counts
Participants
OG00011
Secondary
Objective Response Rate
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab RECIST 1.1 criteria.
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Mean
95% Confidence Interval
percentage of participants
Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Secondary
ORR Using Immune-related (ir) RECIST Criteria
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab using irRECIST 1.1 criteria.
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Mean
95% Confidence Interval
percentage of participants
Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Secondary
Best Overall Response (RECIST 1.1)
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Count of Participants
Participants
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Secondary
Best Overall Response (irRECIST 1.1)
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Count of Participants
Participants
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Secondary
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Number
months
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Secondary
Minimum and Maximum DoR Per RECIST 1.1
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Analysis performed using Response Evaluable Population that includes participants with baseline tumor assessment and at least 1 post-baseline tumor assessment.. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy. .
Posted
Number
months
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Melanoma Cohort
Secondary
Median Progression-free Survival (PFS) Using RECIST 1.1
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
PFS was calculated using the safety population. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy only. Safety assessment was conducted regardless of prior exposure to a PD1 or PDL1 inhibitor.
Posted
Median
95% Confidence Interval
months
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Melanoma Cohort
Secondary
Median PFS Using irRECIST 1.1 Criteria
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
PFS was calculated using the safety population. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy only. Safety assessment was conducted regardless of prior exposure to a PD1 or PDL1 inhibitor.
Posted
Median
95% Confidence Interval
months
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Melanoma Cohort
Secondary
Median Overall Survival
The time from the first infusion of pembrolizumab or retifanlimab until death from any cause.
OS was calculated using the safety population. NSCLC and SCCHN cohorts were subdivided by prior exposure to a PD1 or PDL1 inhibitor for the evaluation of efficacy only. Safety assessment was conducted regardless of prior exposure to a PD1 or PDL1 inhibitor.
Posted
Median
95% Confidence Interval
months
Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
ID
Title
Description
OG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses
OG003
Melanoma Cohort
Time Frame
Adverse events were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, average 12 months. All cause mortality was assessed from the time of first dose until death, up to 18 months.
Description
Adverse event are based on physical findings, patient reports, and significant laboratory values.
Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
On participant was enrolled in the study and never treated so the safety population and all-cause mortality is 145.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1
enoblituzumab 3 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
4
6
1
6
6
6
EG001
Cohort 2
enoblituzumab 10 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
2
3
1
3
3
3
EG002
Cohort 3
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
2
3
2
3
3
3
EG003
Melanoma Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
11
17
8
17
17
17
EG004
Urothelial Cancer Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
16
21
4
21
21
21
EG005
NSCLC Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
33
40
14
40
40
40
EG006
SCCHN Cohort
enoblituzumab 15 mg/kg IV weekly for up to 51 doses and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
30
43
18
43
42
43
EG007
Cohort 4
enoblituzumab 15 mg/kg IV and pembrolizumab 2 mg/kg IV every 3 weeks for up to 17 doses.
0
12
3
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Granulomatous lymphadenitis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected17 at risk
EG004
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Empyema
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)