A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in... | NCT02205333 | Trialant
NCT02205333
Sponsor
MedImmune LLC
Status
Terminated
Last Update Posted
Jun 28, 2017Actual
Enrollment
48Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumors
Aggressive B-cell Lymphomas
Interventions
MEDI6469 Monotherapy
MEDI6469 Plus Tremelimumab
MEDI6469 Plus Durvalumab
MEDI6469 plus Rituximab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02205333
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4981C00001
Secondary IDs
Not provided
Brief Title
A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Official Title
A Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination With Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects With Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas
Acronym
MEDI6469
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Jun 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early at the sponsor's discretion.
Expanded Access Info
No
Start Date
Aug 13, 2014Actual
Primary Completion Date
Apr 8, 2016Actual
Completion Date
Apr 8, 2016Actual
First Submitted Date
Jul 18, 2014
First Submission Date that Met QC Criteria
Jul 29, 2014
First Posted Date
Jul 31, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2017
Results First Submitted that Met QC Criteria
Mar 27, 2017
Results First Posted Date
May 8, 2017Actual
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 1, 2017
Last Update Posted Date
Jun 28, 2017Actual
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
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736 (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469 in a set of participants with advanced solid tumors while rituximab will be tested with MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants with advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumors
Aggressive B-cell Lymphomas
Keywords
Advanced Solid tumors
Diffuse Large B-cell Lymphoma
programmed death 1
programmed dealth ligand 1
cytotoxic T-lymphocyte-associated antigen-4
OX40 ligand
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
48Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI6469 6 mg/kg
Experimental
Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1
Biological: MEDI6469 Monotherapy
MEDI6469 10 mg/kg
Experimental
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Biological: MEDI6469 Monotherapy
MEDI6469 2 mg/kg+Tremelimumab 3 mg/k
Experimental
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1 then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Biological: MEDI6469 Plus Tremelimumab
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Experimental
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1 then Q4W for 6 doses after which Q12W for 2 doses or until progression of disease (PD)
Biological: MEDI6469 Plus Tremelimumab
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Experimental
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1 then every 2 weeks (Q2W) for 12 months or until PD
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI6469 Monotherapy
Biological
single intravenous (IV) administration of MEDI6469
MEDI6469 10 mg/kg
MEDI6469 6 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of MEDI6469
The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
From the first dose of study treatment through 28 days after the first dose (up to 28 days)
Number of Participants With DLTs
The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).
From the first dose of study treatment through 28 days after the first dose (up to 28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Number of Participants With Treatment-emergent Serious Adverse Events
A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR)
Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults >/= 18 years old
Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A and B)
At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
Histologically confirmed DLBCL(Cohort C)
Adequate organ and marrow function
ECOG performance status of 0 or 1
Willingness to provide consent for biopsy samples
Exclusion Criteria:
Prior exposure to immunotherapy (either as a single agent or in combination) including but not limited to CD137 or OX40 agonists, anti-CTLA-4, anti-PD-1, or anti-PD-L1, anti-PD-L2 antibody or pathway-targeting agents
History of organ transplant that requires use of immunosuppressives
History of primary immunodeficiency or tuberculosis
Active or prior documented autoimmune disease within the past 3 years
Active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months
Major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery
Women who are pregnant or lactating
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
MedImmune, LLC
MedImmune LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Scottsdale
Arizona
85259
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 58 participants were screened for this study, of which 48 participants were enrolled and received study treatment.
Recruitment Details
A total of 58 participants were screened at 13 sites in the United States of America (USA).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI6469 6 Milligram/Kilogram (mg/kg)
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
FG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
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
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
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
Parallel 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
Biological: MEDI6469 Plus Durvalumab
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Experimental
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Biological: MEDI6469 Plus Durvalumab
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Experimental
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
Biological: MEDI6469 Plus Durvalumab
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Experimental
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Biological: MEDI6469 plus Rituximab
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Experimental
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Biological: MEDI6469 plus Rituximab
MEDI6469 Plus Tremelimumab
Biological
MEDI6469 in combination with Tremelimumab
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
MEDI6469 2 mg/kg+Tremelimumab 3 mg/k
MEDI6469 Plus Durvalumab
Biological
MEDI6469 in combination with Durvalumab
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
MEDI6469 plus Rituximab
Biological
MEDI6469 in combination with Rituximab
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
From study entry until early termination (up to 1 year)
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.
From study entry until early termination (up to 1 year)
Disease Control Rate
Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.
From study entry until early termination (up to 1 year)
Duration of Response (DOR)
Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
From Study entry until early termination (up to 1 year)
Progression-free Survival (PFS)
Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
From Study entry until early termination (up to 1 year)
Overall Survival (OS)
The OS was the duration from the start of study treatment until death due to any cause.
From Study entry until early termination (up to 1 year)
Maximum Observed Serum Concentration (Cmax)
The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Systemic Clearance (CL)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Terminal Phase Elimination Half-Life (T1/2)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)
The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).
All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)
Sacramento
California
95817
United States
Research Site
Santa Monica
California
90404
United States
Research Site
Washington D.C.
District of Columbia
20007
United States
Research Site
Tampa
Florida
33612
United States
Research Site
Chicago
Illinois
60611
United States
Research Site
Detroit
Michigan
48202
United States
Research Site
Las Vegas
Nevada
89169
United States
Research Site
Hackensack
New Jersey
7601
United States
Research Site
Huntersville
North Carolina
28078
United States
Research Site
Portland
Oregon
97213
United States
Research Site
Memphis
Tennessee
38120
United States
Research Site
Houston
Texas
77030
United States
FG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
FG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
FG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
FG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
FG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
FG007
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
FG008
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
FG0008 subjects
FG0016 subjects
FG0023 subjects
FG0037 subjects
FG0046 subjects
FG0057 subjects
FG0067 subjects
FG0073 subjects
FG0081 subjects
COMPLETED
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0062 subjects
FG0071 subjects
FG0081 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG0022 subjects
FG0037 subjects
FG0045 subjects
FG0053 subjects
FG0065 subjects
FG0072 subjects
FG0080 subjects
Type
Comment
Reasons
Death
FG0005 subjects
FG0016 subjects
FG0022 subjects
FG0036 subjects
FG0045 subjects
FG0053 subjects
FG0063 subjects
FG0072 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI6469 6 Milligram/Kilogram (mg/kg)
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
BG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
BG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
BG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
BG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
BG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
BG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
BG007
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
BG008
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG0023
BG0037
BG0046
BG0057
BG0067
BG0073
BG0081
BG00948
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
BG00060.5± 12.6
BG00163.8± 8.9
BG00248.0± 6.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0013
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
Maximum Tolerated Dose (MTD) of MEDI6469
The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.
Posted
Number
milligram per kilogram (mg/kg)
From the first dose of study treatment through 28 days after the first dose (up to 28 days)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NADose escalation was completed without determination of MTD.
OG001NADose escalation was completed without determination of MTD.
OG002NADose escalation was terminated early prior to completion of the protocol-specified dose ranges.
Primary
Number of Participants With DLTs
The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).
DLT-evaluable population
Posted
Number
Participant
From the first dose of study treatment through 28 days after the first dose (up to 28 days)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.
As-treated population: all the participants who received any study treatment.
Posted
Number
Participant
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Primary
Number of Participants With Treatment-emergent Serious Adverse Events
A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.
As-treated population
Posted
Number
Participant
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Primary
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.
As-treated population
Posted
Number
Participant
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Primary
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.
As-treated population
Posted
Number
Participant
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.
As-treated population
Posted
Number
Participant
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
Secondary
Best Overall Response (BOR)
Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.
As-treated population
Posted
Number
Percentage of participants
From study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Secondary
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.
As-treated population
Posted
Number
Percentage of participants
From study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Secondary
Disease Control Rate
Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.
As-treated population
Posted
Number
Percentage of participants
From study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
Secondary
Duration of Response (DOR)
Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
All the participants with an OR were included.
Posted
Number
Days
From Study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Progression-free Survival (PFS)
Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
As-treated population
Posted
Median
95% Confidence Interval
Months
From Study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Overall Survival (OS)
The OS was the duration from the start of study treatment until death due to any cause.
As-treated population
Posted
Median
95% Confidence Interval
Months
From Study entry until early termination (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
Secondary
Maximum Observed Serum Concentration (Cmax)
The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
microgram per milliliter
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
day*microgram per milliliter
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Systemic Clearance (CL)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
liter per day
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Terminal Phase Elimination Half-Life (T1/2)
The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
Day
MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Secondary
Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)
The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).
All the participants who received at least a one dose of MEDI6469.
Posted
Number
Participant
All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)
ID
Title
Description
OG000
MEDI6469 6 mg/kg
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
OG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
Time Frame
From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
Description
Not provided
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
MEDI6469 6 Milligram/Kilogram (mg/kg)
Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
4
8
6
8
EG001
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
3
6
6
6
EG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
1
3
3
3
EG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
5
7
7
7
EG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
3
6
6
6
EG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
3
7
7
7
EG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
3
7
7
7
EG007
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
2
3
3
3
EG008
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected7 at risk
EG0062 events1 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0003 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleural infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Obstructive uropathy
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Scrotal swelling
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0003 events2 affected8 at risk
EG0013 events2 affected6 at risk
EG0023 events2 affected3 at risk
EG0033 events2 affected7 at risk
EG0042 events1 affected6 at risk
EG0051 events1 affected7 at risk
EG0062 events2 affected7 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected1 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0003 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0004 events3 affected8 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0005 events3 affected8 at risk
EG0012 events2 affected6 at risk
EG0025 events3 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.0
Systematic Assessment
EG0003 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0003 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0003 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0013 events3 affected6 at risk
EG0023 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0003 events2 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0005 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0015 events2 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
The study was terminated early at the Sponsor's discretion.
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 ongoing 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Victoria Chiou
MedImmune, LLC
301-398-4330
chiouv@MedImmune.com
ID
Term
D016403
Lymphoma, Large B-Cell, Diffuse
Ancestor Terms
ID
Term
D016393
Lymphoma, B-Cell
D008228
Lymphoma, Non-Hodgkin
D008223
Lymphoma
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C520704
tremelimumab
C000613593
durvalumab
D000069283
Rituximab
Ancestor Terms
ID
Term
D058846
Antibodies, Monoclonal, Murine-Derived
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
61.3
± 8.7
BG00457.5± 19.4
BG00566.6± 14.5
BG00662.6± 9.1
BG00770.3± 4.6
BG00873.0± NANot evaluable due to insufficient number of participants.
BG00961.9± 12.2
2
BG0032
BG0043
BG0051
BG0063
BG0071
BG0080
BG00920
Male
BG0003
BG0013
BG0021
BG0035
BG0043
BG0056
BG0064
BG0072
BG0081
BG00928
7
OG0046
OG0057
OG0067
OG0073
OG0081
OG003NADose escalation was terminated early prior to completion of the protocol-specified dose ranges.
OG004NADose escalation was completed without determination of MTD.
OG005NADose escalation was completed without determination of MTD.
OG006NADose escalation was completed without determination of MTD.
OG007NADose escalation was terminated early prior to completion of the protocol-specified dose ranges.
OG008NADose escalation was terminated early prior to completion of the protocol-specified dose ranges.
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0051
OG0060
OG0070
OG0080
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0021
OG0035
OG0043
OG0053
OG0063
OG0072
OG0080
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Anemia
Title
Measurements
OG0002
OG0012
OG0022
OG0032
OG0042
OG0051
OG0063
OG0071
OG0081
Neutrophil count increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Neutrophil count decreased
Title
Measurements
OG0000
OG0010
OG0022
OG003
Lymphopenia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood iron decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lymphocyte count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypernatremia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hypokalemia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypomagnesemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperglycemia
Title
Measurements
OG0002
OG0010
OG0021
OG003
Alanine aminotransferase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood creatinine increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypercalcemia
Title
Measurements
OG0002
OG0011
OG0020
OG003
Hyperkalemia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Hypoalbuminemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hyperuricemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypophosphatemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood cholesterol increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood glucose increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood thyroid stimulating hormone increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypocalcemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypothyroidism
Title
Measurements
OG0000
OG0010
OG0020
OG003
Iron deficiency
Title
Measurements
OG0000
OG0011
OG0020
OG003
Liver function test increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tri-iodothyronine free decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Troponin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thyroxine free decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematuria
Title
Measurements
OG0000
OG0010
OG0021
OG003
Activated partial thromboplastin time prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Pyrexia
Title
Measurements
OG0001
OG0012
OG0022
OG0032
OG0040
OG0053
OG0062
OG0070
OG0080
Dyspnea
Title
Measurements
OG0000
OG0012
OG0021
OG003
Hypotension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dyspnea exertional
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tachycardia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Bradycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertension
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypoxia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Wheezing
Title
Measurements
OG0000
OG0010
OG0020
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
PR
Title
Measurements
OG0000
OG0010
OG0020
OG003
SD
Title
Measurements
OG00012.5
OG0010
OG00233.3
OG003
PD
Title
Measurements
OG00050.0
OG00133.3
OG00266.7
OG003
NE
Title
Measurements
OG00037.5
OG00166.7
OG0020
OG003
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00416.7
OG0050
OG0060
OG0070
OG0080
OG002
MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG00012.5
OG0010
OG00233.3
OG00328.6
OG00450.0
OG00514.3
OG0060
OG00733.3
OG008100.0
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG004368
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0001.8(0.9 to 3.5)
OG0011.8(1.8 to 1.8)
OG0021.9(1.8 to 6.4)
OG0032.8(0.7 to 6.7)
OG0045.6(1.0 to 17.8)
OG0051.8(1.0 to 6.4)
OG0061.4(1.0 to 1.8)
OG0071.0(0.9 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG0085.4(NA to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0006.1(0.9 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG0016.5(1.8 to 10.7)
OG00213.1(11.2 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG0036.7(2.0 to 12.5)
OG00411.2(1.2 to 17.8)
OG005NA(1.0 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG0062.9(2.5 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG0073.3(1.7 to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG008NA(NA to NA)Not evaluable due to insufficient number of participants achieved this endpoint
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG000133.76± 34.87
OG001188.87± 59.88
OG00249.00± 1.29
OG00343.67± 7.99
OG00440.21± 8.20
OG00542.10± 6.63
OG006234.91± 56.05
OG00731.68± 5.06
OG008289.40± NANot evaluable due to insufficient number of participants achieved this endpoint
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG000556.92± 166.95
OG001873.16± 328.74
OG002169.34± 18.15
OG003183.09± 26.27
OG004144.91± 33.07
OG005169.65± 45.98
OG006998.25± 400.12
OG007145.55± 16.86
OG0081619.73± NANot evaluable due to insufficient number of participants achieved this endpoint
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0000.81± 0.224
OG0010.84± 0.246
OG0021.02± 0.155
OG0030.89± 0.132
OG0041.04± 0.288
OG0051.0± 0.266
OG0060.84± 0.173
OG0071.11± 0.188
OG0080.77± NANot evaluable due to insufficient number of participants achieved this endpoint
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
Units
Counts
Participants
OG0008
OG0016
OG0023
OG0037
OG0046
OG0057
OG0067
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG0002.83± 0.83
OG0013.20± 1.23
OG0021.56± 0.04
OG0032.86± 0.68
OG0042.73± 0.65
OG0053.30± 0.68
OG0062.98± 1.06
OG0073.75± 1.03
OG0084.19± NANot evaluable due to insufficient number of participants achieved this endpoint
OG003
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
OG004
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
OG005
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG006
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
OG007
MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
OG008
MEDI6469 10 mg/kg + Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD