Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for P... | NCT03310957 | Trialant
NCT03310957
Sponsor
Seagen Inc.
Status
Completed
Last Update Posted
Dec 12, 2025Actual
Enrollment
185Actual
Phase
Phase 1Phase 2
Conditions
Triple Negative Breast Neoplasms
Interventions
ladiratuzumab vedotin
Pembrolizumab
Countries
United States
Germany
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03310957
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SGNLVA-002
Secondary IDs
ID
Type
Description
Link
KEYNOTE 721
Other Identifier
Merck Sharp & Dohme LLC
2017-002289-35
EudraCT Number
MK-3475-721
Other Identifier
Merck Sharp & Dohme LLC
Brief Title
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Official Title
Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Acronym
Not provided
Organization
Seagen Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 27, 2018Actual
Primary Completion Date
Sep 30, 2024Actual
Completion Date
Sep 30, 2024Actual
First Submitted Date
Oct 11, 2017
First Submission Date that Met QC Criteria
Oct 11, 2017
First Posted Date
Oct 16, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Sep 23, 2025
Results First Submitted that Met QC Criteria
Dec 1, 2025
Results First Posted Date
Dec 12, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 1, 2025
Last Update Posted Date
Dec 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Seagen Inc.INDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
Detailed Description
The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action.
This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.
Conditions Module
Conditions
Triple Negative Breast Neoplasms
Keywords
Breast cancer
Breast carcinoma
Triple negative breast cancer
Locally-advanced breast cancer
Metastatic breast cancer
Tumors, breast
Breast tumors
pembrolizumab
LIV-1 protein, human
Ladiratuzumab vedotin
hLIV22-vcMMAE
Seattle Genetics
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
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LV + pembrolizumab
Experimental
LV + pembrolizumab
Drug: ladiratuzumab vedotin
Drug: Pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ladiratuzumab vedotin
Drug
Given into the vein (IV; intravenously)
LV + pembrolizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.
From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
Number of Participants With Treatment Related TEAEs and SAEs
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.
From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR) Per RECIST v1.1
DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to <10 mm). PR: >=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
Part D only: Tumor tissue PD-L1 Combined Positive Score <10 expression.
Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
At least 6 months since prior treatment with curative intent and recurrence
At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Able to provide biopsy tissue for biomarker analysis
Meet baseline laboratory data criteria
Exclusion Criteria:
Prior immune-oncology therapy
Pre-existing neuropathy of at least Grade 2
History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids.
Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy
Active autoimmune disease requiring systemic treatment within the past 2 years
History of interstitial lung disease
Current pneumonitis or history of pneumonitis requiring steroids
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Zejing Wang, MD, PhD
Seagen Inc.
Study Director
Kristel Apolinario, PharmD
Seagen Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham
Birmingham
Alabama
35249
United States
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
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
Participants were enrolled into Part A, Part B, Part C, and Part D sequentially.
Recruitment Details
A total of 185 participants were enrolled at multiple sites.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 milligram per kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of each 21-day cycle every 3 weeks (Q3WK) given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 19, 2023
Sep 23, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
LV
SGN-LIV1A
Pembrolizumab
Drug
IV infusion every 3 weeks
LV + pembrolizumab
KEYTRUDA®
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.
From start of study treatment up to 30 days for AEs (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months)
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.
Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.
Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C
DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).
Cycle 1 (up to 21 days)
ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.
From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)
From the date of first CR or PR until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
Disease Control Rate (DCR)
DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.
From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)
Progression-Free Survival (PFS)
PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.
From start of study treatment until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
Overall Survival (OS)
OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.
From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)
Los Angeles
California
90048
United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange
California
92868
United States
University of California Irvine - Newport
Orange
California
92868
United States
Rocky Mountain Cancer Centers - Aurora
Aurora
Colorado
80012
United States
The Whittingham Cancer Center / Norwalk Hospital
Norwalk
Connecticut
06856
United States
Helen F. Graham Cancer Center / Christiana Care Health Systems
Newark
Delaware
19713
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami
Florida
33176
United States
AdventHealth Cancer Institute
Orlando
Florida
32804
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
33612
United States
Piedmont Cancer Institute
Atlanta
Georgia
30309
United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta
Georgia
30322
United States
Ingalls Cancer Care / Ingalls Memorial Hospital
Harvey
Illinois
60426
United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood
Illinois
60153
United States
University of Maryland
Baltimore
Maryland
21201
United States
Allina Health Cancer Institute
Minneapolis
Minnesota
55407
United States
Saint Luke's Cancer Institute LLC
Kansas City
Missouri
64111
United States
Summit Medical Group
Florham Park
New Jersey
07932
United States
New Mexico Cancer Center
Albuquerque
New Mexico
87131
United States
Weill Cornell Medicine
New York
New York
10065
United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh
Pennsylvania
15232
United States
Texas Oncology - DFW
Dallas
Texas
75246
United States
Texas Oncology - Houston Memorial City
Houston
Texas
77024
United States
Texas Oncology - San Antonio Medical Center Northeast
San Antonio
Texas
78212
United States
University of Virginia
Charlottesville
Virginia
22903
United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle
Washington
98109-1023
United States
Gynakologisches Zentrum Bonn Friedensplatz
Bonn
Other
53111
Germany
Marien Hospital Bottrop
Bottrop
Other
46236
Germany
Stadtisches Klinikum Dessau
Dessau
Other
06847
Germany
Universitatsklinikum Erlangen
Erlangen
Other
91054
Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
Essen
Other
45136
Germany
Rotkreuzklinikum Munich
Munich
Other
80637
Germany
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
München
Other
81675
Germany
Klinikum der Universitat Munchen
München
80337
Germany
Pusan National University Hospital
Busan
Other
49201
South Korea
CHA Bundang Medical Center
Seongnam
Other
13496
South Korea
Korea Cancer Center Hospital
Seoul
Other
01802
South Korea
Seoul National University Hospital
Seoul
Other
03080
South Korea
Severance Hospital, Yonsei University Health System
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.
FG002
Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.
FG003
Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.
FG004
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle every week (Q1WK) by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
FG005
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
FG006
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle twice every 3 weeks (2Q3WK) by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part D.
FG0007 subjects
FG00112 subjects
FG00226 subjects
FG00347 subjects
FG0043 subjects
FG00553 subjects
FG00637 subjects
Treated
FG0007 subjects
FG00112 subjects
FG00226 subjects
FG00347 subjects
FG0043 subjects
FG00553 subjects
FG00637 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0007 subjects
FG00112 subjects
FG00226 subjects
FG00347 subjects
FG0043 subjects
FG00553 subjects
FG00637 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0040 subjects
FG0054 subjects
FG0063 subjects
Site Terminated
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG004
Death
FG0005 subjects
FG0018 subjects
FG00218 subjects
FG00331 subjects
FG004
Discontinuation per sponsor
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0034 subjects
FG004
Discontinuation per protocol amendment 11
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Treatment landscape
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Alanine aminotransferase (ALT) increased
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Elevated Aspartate aminotransferase (AST)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Hospice
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
As pre-specified in the statistical analysis plan (SAP), data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
BG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
BG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
BG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
BG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00033
BG00159
BG0023
BG00353
BG00437
BG005185
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.4± 12.1
BG00155.2± 12.7
BG00245.0± 14.1
BG003
Sex: Female, Male
As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG001
Ethnicity (NIH/OMB)
As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG001
Race/Ethnicity, Customized
Race is reported.
As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00019
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.
Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Count of Participants
Participants
From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG003
Title
Denominators
Categories
Participants With TEAEs
Title
Measurements
OG00032
OG00159
OG0022
OG003
Primary
Number of Participants With Treatment Related TEAEs and SAEs
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.
Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Count of Participants
Participants
From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.
Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Count of Participants
Participants
From start of study treatment up to 30 days for AEs (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.
Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Count of Participants
Participants
Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.
Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Count of Participants
Participants
Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C
DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).
DLT-evaluable (DE) analysis included all treated participants in Part A who either (1) experienced a DLT or (2) received at least 75% of intended SGN-LIV1A and pembrolizumab doses and were followed for the full DLT evaluation period. This outcome measure was planned to be analyzed only in Part A and Part C arms.
Posted
Count of Participants
Participants
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 milligram per kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of each 21-day cycle every 3 weeks (Q3WK) given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.
OG001
Primary
ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.
All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Number
95% Confidence Interval
Percentage of participants
From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Secondary
Duration of Response (DOR) Per RECIST v1.1
DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to <10 mm). PR: >=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.
All treated analysis set: all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Median
95% Confidence Interval
Months
From the date of first CR or PR until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Secondary
Disease Control Rate (DCR)
DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.
All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Number
95% Confidence Interval
Percentage of participants
From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.
All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Median
95% Confidence Interval
Months
From start of study treatment until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Secondary
Overall Survival (OS)
OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.
All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
Posted
Median
95% Confidence Interval
Months
From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)
ID
Title
Description
OG000
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Time Frame
From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; All-cause mortality, SAEs = maximum up to 30 months)
Description
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
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
Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.
5
7
4
7
7
7
EG001
Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.
8
12
8
12
12
12
EG002
Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.
18
26
13
26
23
26
EG003
Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.
31
47
27
47
47
47
EG004
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
1
3
1
3
2
3
EG005
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
29
53
28
53
53
53
EG006
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part D.
7
37
14
37
36
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected47 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected53 at risk
EG0060 events0 affected37 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Keratitis
Eye disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Intestinal pseudo-obstruction
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Asthenia
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Device related thrombosis
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Gait disturbance
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Immune-mediated cholangitis
Hepatobiliary disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Haemophagocytic lymphohistiocytosis
Immune system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Immune-mediated adverse reaction
Immune system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Abscess limb
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Cystitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Cytomegalovirus gastritis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Device related infection
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Lymph gland infection
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Mastitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Parotitis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Septic shock
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Lipoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Ataxia
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events1 affected12 at risk
EG0025 events3 affected26 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0002 events1 affected7 at risk
EG0015 events5 affected12 at risk
EG0027 events6 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral sensorimotor neuropathy
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0017 events5 affected12 at risk
EG0028 events8 affected26 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Tremor
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Vocal cord paresis
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected12 at risk
EG0023 events3 affected26 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Depression
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events4 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events3 affected12 at risk
EG0024 events4 affected26 at risk
EG003
Irritability
Psychiatric disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA v27.1
Systematic Assessment
EG0002 events2 affected7 at risk
EG0013 events3 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0013 events3 affected12 at risk
EG0026 events6 affected26 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0003 events3 affected7 at risk
EG0013 events3 affected12 at risk
EG0025 events5 affected26 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0022 events1 affected26 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0005 events5 affected7 at risk
EG0017 events7 affected12 at risk
EG0027 events7 affected26 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events2 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0014 events3 affected12 at risk
EG0025 events5 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0018 events5 affected12 at risk
EG0025 events5 affected26 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected26 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events2 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Haematoma
Vascular disorders
MedDRA v27.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hot flush
Vascular disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.1
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected26 at risk
EG003
Hypotension
Vascular disorders
MedDRA v27.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected12 at risk
EG0022 events2 affected26 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Participants With Treatment Related TEAEs
Title
Measurements
OG00029
OG00158
OG0022
OG00352
OG00435
Participants With Treatment Related SAEs
Title
Measurements
OG0006
OG00120
OG0020
OG003
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
< Grade 3
Title
Measurements
OG00010
OG00110
OG0020
OG0036
OG0045
>= Grade 3
Title
Measurements
OG00022
OG00149
OG0022
OG003
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
Grade 0
OG0002
OG0013
OG0020
OG0034
OG0042
Grade 1
OG0006
OG0018
OG0021
OG0036
OG004
Grade 2
OG00012
OG00127
OG0021
OG00325
OG004
Grade 3
OG0008
OG00115
OG0020
OG00314
OG004
Grade 4
OG0001
OG0015
OG0020
OG0034
OG004
Missing
OG0003
OG0011
OG0020
OG0030
OG004
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
Grade 1
OG00010
OG0019
OG0021
OG0034
OG00412
Grade 2
OG0006
OG0014
OG0021
OG00310
OG004
Garde 3
OG00012
OG00137
OG0020
OG00336
OG004
Grade 4
OG0001
OG0019
OG0020
OG0033
OG004
Missing
OG0003
OG0010
OG0020
OG0030
OG004
Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle every week (Q1WK) by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.
Units
Counts
Participants
OG0007
OG00112
OG0022
OG0032
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
OG0030
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
OG00034(18.6 to 53.2)
OG00141(28.1 to 54.3)
OG00250(1.3 to 98.7)
OG00347(33.3 to 61.4)
OG00439(23.1 to 56.5)
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00011
OG00124
OG0021
OG00325
OG00414
Title
Denominators
Categories
Title
Measurements
OG0004.5(2.9 to 6.9)
OG0015.8(3.1 to 9.9)
OG0024.2(NA to NA)Upper and lower limit of 95%CI could not be estimated due to insufficient number of participants with events.
OG0034.4(3.6 to 6.6)
OG0048.3(5.7 to NA)Lower limit of 95%CI could not be estimated due to insufficient number of participants with events.
OG001
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
OG00059(40.6 to 76.3)
OG00181(69.1 to 90.3)
OG00250(1.3 to 98.7)
OG00377(63.8 to 87.7)
OG00469(51.9 to 83.7)
Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.
OG002
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
OG0003.5(1.7 to 4.1)
OG0014.2(3.9 to 5.6)
OG0023.3(1.0 to NA)Upper limit of 95%CI could not be estimated due to insufficient participants with events.
OG0034.8(4.1 to 5.6)
OG0044.2(2.7 to 8.3)
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab
Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
OG003
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab
Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.
OG004
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab
Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00032
OG00159
OG0022
OG00353
OG00436
Title
Denominators
Categories
Title
Measurements
OG00014.6(8.1 to 26.6)
OG00114.8(11.9 to 25.9)
OG002NA(NA to NA)Median and upper -lower limit of 95%CI could not be estimated due to insufficient number of participants with events. Only 1 participant had event with OS of 3.4 months.
OG00319.4(11.1 to NA)Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
OG004NA(NA to NA)Median and upper and lower limit of 95%CI could not be estimated due to insufficient number of participants with events.