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GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02528357
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: GSK3174998
Drug: Pembrolizumab
Enrollment 141
Recruitment Details This was a 2 part study conducted across 4 countries. Part 1 was dose-escalation study to evaluate GSK3174998 monotherapy. Part 2 included dose-escalation cohorts of GSK3174998+pembrolizumab combination therapy (Comb. Th.) (Part 2A) and dose-expansion (Expan.) disease specific cohorts (Coh.) of GSK3174998 + pembrolizumab (Part 2B).
Pre-assignment Details A total of 141 participants were enrolled in the study: 45 participants in Part 1 and 96 participants in Part 2 (74 in Part 2A+ 22 in Part 2B).
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1. Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1. Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B. Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B. Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Period Title: Part1:Monotherapy(Up to Maximum 39weeks)
Started 1 1 8 10 10 4 7 4 0 0 0 0 0 0 0 0 0 0 0
Completed 1 0 6 9 6 2 5 2 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 1 2 1 4 2 2 2 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Physician Decision             0             0             0             1             0             2             0             1             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             2             0             3             0             2             1             0             0             0             0             0             0             0             0             0             0             0
Follow-up assessments removed (Protocol Amendment 4)             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: Part2A:Comb. Th. (Up to Maximum 105wks)
Started 0 0 0 0 0 0 0 0 5 5 10 12 14 12 12 4 0 0 0
Completed 0 0 0 0 0 0 0 0 4 4 7 9 9 6 5 4 0 0 0
Not Completed 0 0 0 0 0 0 0 0 1 1 3 3 5 6 7 0 0 0 0
Reason Not Completed
Investigator site closed             0             0             0             0             0             0             0             0             0             0             0             0             0             1             5             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             3             0             1             3             1             0             0             0             0
Follow-up assessments removed (Protocol Amendment 4)             0             0             0             0             0             0             0             0             1             1             0             3             4             1             1             0             0             0             0
Period Title: Part2B:Expan. Coh.(Up to Maximum 33 Wks)
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 8 5
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 4 2
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 4 3
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0             0
Follow-up assessments removed (Protocol Amendment 4)             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             4             3
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort Total
Hide Arm/Group Description Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1. Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1. Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1. Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A. Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B. Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B. Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B. Total of all reporting groups
Overall Number of Baseline Participants 1 1 8 10 10 4 7 4 5 5 10 12 14 12 12 4 9 8 5 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants 5 participants 5 participants 10 participants 12 participants 14 participants 12 participants 12 participants 4 participants 9 participants 8 participants 5 participants 141 participants
18 to 64 years
1
 100.0%
0
   0.0%
5
  62.5%
8
  80.0%
4
  40.0%
2
  50.0%
4
  57.1%
2
  50.0%
1
  20.0%
3
  60.0%
6
  60.0%
6
  50.0%
8
  57.1%
6
  50.0%
6
  50.0%
1
  25.0%
6
  66.7%
5
  62.5%
2
  40.0%
76
  53.9%
65 to 84 years
0
   0.0%
1
 100.0%
3
  37.5%
2
  20.0%
6
  60.0%
2
  50.0%
3
  42.9%
2
  50.0%
4
  80.0%
2
  40.0%
4
  40.0%
6
  50.0%
6
  42.9%
6
  50.0%
6
  50.0%
2
  50.0%
3
  33.3%
3
  37.5%
3
  60.0%
64
  45.4%
>=85 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants 5 participants 5 participants 10 participants 12 participants 14 participants 12 participants 12 participants 4 participants 9 participants 8 participants 5 participants 141 participants
Female NA [1]  NA [1] 
6
  75.0%
6
  60.0%
5
  50.0%
1
  25.0%
6
  85.7%
3
  75.0%
3
  60.0%
3
  60.0%
8
  80.0%
5
  41.7%
6
  42.9%
3
  25.0%
8
  66.7%
0
   0.0%
3
  33.3%
4
  50.0%
1
  20.0%
NA [2] 
Male NA [1]  NA [1] 
2
  25.0%
4
  40.0%
5
  50.0%
3
  75.0%
1
  14.3%
1
  25.0%
2
  40.0%
2
  40.0%
2
  20.0%
7
  58.3%
8
  57.1%
9
  75.0%
4
  33.3%
4
 100.0%
6
  66.7%
4
  50.0%
4
  80.0%
NA [2] 
[1]
Data not reported due to participant's confidentiality and privacy concerns
[2]
Total not calculated because data are not available (NA) in one or more arms.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants 5 participants 5 participants 10 participants 12 participants 14 participants 12 participants 12 participants 4 participants 9 participants 8 participants 5 participants 141 participants
African American/African Heritage NA [1]  NA [1] 
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
2
  16.7%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
NA [2] 
Asian - Central/South Asian Heritage NA [1]  NA [1] 
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NA [2] 
Asian - East Asian Heritage NA [1]  NA [1] 
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
NA [2] 
Asian - South East Asian Heritage NA [1]  NA [1] 
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NA [2] 
White - Arabic/North African Heritage NA [1]  NA [1] 
1
  12.5%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NA [2] 
White - White/Caucasian/European Heritage NA [1]  NA [1] 
6
  75.0%
7
  70.0%
10
 100.0%
4
 100.0%
7
 100.0%
3
  75.0%
5
 100.0%
5
 100.0%
10
 100.0%
12
 100.0%
12
  85.7%
7
  58.3%
10
  83.3%
2
  50.0%
9
 100.0%
6
  75.0%
4
  80.0%
NA [2] 
Missing NA [1]  NA [1] 
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
2
  25.0%
0
   0.0%
NA [2] 
[1]
Data not reported due to participant's confidentiality and privacy concerns
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Part 1: Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (Non-SAE)
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
Time Frame Up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population consisted of all participants who received at least one dose of GSK3174998.
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE
1
 100.0%
0
   0.0%
3
  37.5%
7
  70.0%
2
  20.0%
1
  25.0%
2
  28.6%
1
  25.0%
Any non-SAE
1
 100.0%
1
 100.0%
8
 100.0%
10
 100.0%
10
 100.0%
4
 100.0%
7
 100.0%
4
 100.0%
2.Primary Outcome
Title Part 2A: Number of Participants With Any SAE and Non-SAE
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
Time Frame Up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE
1
  20.0%
1
  20.0%
6
  60.0%
4
  33.3%
4
  28.6%
4
  33.3%
2
  16.7%
2
  50.0%
Any non-SAE
5
 100.0%
5
 100.0%
10
 100.0%
12
 100.0%
13
  92.9%
12
 100.0%
12
 100.0%
4
 100.0%
3.Primary Outcome
Title Part 2B: Number of Participants With Any SAE and Non-SAE
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.
Time Frame Up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE
1
  11.1%
2
  25.0%
1
  20.0%
Any non-SAE
9
 100.0%
8
 100.0%
4
  80.0%
4.Primary Outcome
Title Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description An adverse event was considered as DLT if it was considered by the investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment, occurred within the first 28 days of the treatment, and met 1 of the following criteria: Hematologic: Febrile neutropenia, Grade4 neutropenia of >7days requiring Granulocyte colony-stimulating factor (G-CSF), Grade4 anemia of any duration, Grade4 thrombocytopenia of any duration or Grade3 thrombocytopenia with bleeding as described in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4). Non-hematologic: Grade4 toxicity, Grade3 toxicity that cannot be controlled within 3days, Ocular toxicity of >=Grade3 or of Grade2 requiring systemic steroids. Any other event results in permanent discontinuation of treatment during the first 4 weeks of treatment or any other event which in the judgment of the investigator and GlaxoSmithKline medical monitor is considered to be a DLT.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Part 2A: Number of Participants With DLTs
Hide Description An adverse event was considered as DLT if it was considered by the investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment, occurred within the first 28 days of the treatment, and met 1 of the following criteria: Hematologic: Febrile neutropenia, Grade4 neutropenia of >7days requiring Granulocyte colony-stimulating factor (G-CSF), Grade4 anemia of any duration, Grade4 thrombocytopenia of any duration or Grade3 thrombocytopenia with bleeding as described in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4). Non-hematologic: Grade4 toxicity, Grade3 toxicity that cannot be controlled within 3days, Ocular toxicity of >=Grade3 or of Grade2 requiring systemic steroids. Any other event results in permanent discontinuation of treatment during the first 4 weeks of treatment or any other event which in the judgment of the investigator and GlaxoSmithKline medical monitor is considered to be a DLT.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
6.Primary Outcome
Title Part 2B: Number of Participants With DLTs
Hide Description An adverse event was considered as DLT if it was considered by the investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment, occurred within the first 28 days of the treatment, and met 1 of the following criteria: Hematologic: Febrile neutropenia, Grade4 neutropenia of >7days requiring Granulocyte colony-stimulating factor (G-CSF), Grade4 anemia of any duration, Grade4 thrombocytopenia of any duration or Grade3 thrombocytopenia with bleeding as described in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4). Non-hematologic: Grade4 toxicity, Grade3 toxicity that cannot be controlled within 3days, Ocular toxicity of >=Grade3 or of Grade2 requiring systemic steroids. Any other event results in permanent discontinuation of treatment during the first 4 weeks of treatment or any other event which in the judgment of the investigator and GlaxoSmithKline medical monitor is considered to be a DLT.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Part 1: Number of Participants With Any Adverse Event Leading to Withdrawal (AELD) From the Study
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any adverse event leading to withdrawal from the study is presented.
Time Frame Up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Part 2A: Number of Participants With Any Adverse Event Leading to Withdrawal From the Study
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any adverse event leading to withdrawal from the study is presented.
Time Frame Up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Part 2B: Number of Participants With Any Adverse Event Leading to Withdrawal From the Study
Hide Description An adverse event is any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any adverse event leading to withdrawal from the study is presented.
Time Frame Up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Part 1: Number of Participants With Dose Reductions or Delay
Hide Description Number of participants who had any dose reduction or dose delay (GSK3174998) due to any reason have been presented.
Time Frame Up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
Dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dose delay
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Part 2A: Number of Participants With Dose Reductions or Delay
Hide Description Number of participants who had any dose reduction or dose delay (GSK3174998) due to any reason have been presented.
Time Frame Up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dose delay
0
   0.0%
0
   0.0%
1
  10.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Part 2B: Number of Participants With Dose Reductions or Delay
Hide Description Number of participants who had any dose reduction or dose delay (GSK3174998) due to any reason have been presented.
Time Frame Up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
Dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
Dose delay
0
   0.0%
0
   0.0%
0
   0.0%
13.Primary Outcome
Title Part 1: Number of Participants With Any Grade Change From Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), leukocyte count (leuko.), lymphocyte count (Lymph.), neutrophil count (Neutro.) and platelet count (PC). The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
Hb decreased (anemia)
1
 100.0%
0
   0.0%
7
  87.5%
6
  60.0%
5
  50.0%
3
  75.0%
0
   0.0%
1
  25.0%
Hb increased
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. increased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. decreased
0
   0.0%
0
   0.0%
2
  25.0%
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymph. decreased
0
   0.0%
0
   0.0%
5
  62.5%
3
  30.0%
6
  60.0%
1
  25.0%
5
  71.4%
3
  75.0%
Lymph. increased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutro. decreased
0
   0.0%
0
   0.0%
1
  12.5%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC decreased
0
   0.0%
0
   0.0%
1
  12.5%
1
  10.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Primary Outcome
Title Part 2A: Number of Participants With Any Grade Change From Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of following hematology parameters: Hb, leuko., Lymph., Neutro. and PC. The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Hb decreased (anemia)
2
  40.0%
2
  40.0%
2
  20.0%
5
  41.7%
4
  28.6%
3
  25.0%
5
  41.7%
1
  25.0%
Hb increased
1
  20.0%
0
   0.0%
1
  10.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. increased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. decreased
1
  20.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   8.3%
3
  25.0%
1
  25.0%
Lymph. decreased
2
  40.0%
2
  40.0%
5
  50.0%
2
  16.7%
6
  42.9%
4
  33.3%
3
  25.0%
2
  50.0%
Lymph. increased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Neutro. decreased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
PC decreased
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
15.Primary Outcome
Title Part 2B: Number of Participants With Any Grade Change From Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of following hematology parameters: Hb, leuko., Lymph., Neutro. and PC. The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
Hb decreased (anemia)
2
  22.2%
2
  25.0%
1
  20.0%
Hb increased
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. increased
0
   0.0%
0
   0.0%
0
   0.0%
Leuko. decreased
1
  11.1%
0
   0.0%
0
   0.0%
Lymph. decreased
3
  33.3%
3
  37.5%
2
  40.0%
Lymph. increased
0
   0.0%
0
   0.0%
0
   0.0%
Neutro. decreased
0
   0.0%
0
   0.0%
0
   0.0%
PC decreased
1
  11.1%
1
  12.5%
1
  20.0%
16.Primary Outcome
Title Part 1: Number of Participants With Any Grade Change From Baseline in Liver Function Laboratory Parameters
Hide Description Blood samples were collected for the analysis of following liver function laboratory parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and bilirubin. The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
ALT increased
0
   0.0%
0
   0.0%
1
  12.5%
2
  20.0%
0
   0.0%
2
  50.0%
1
  14.3%
1
  25.0%
ALP increased
1
 100.0%
0
   0.0%
3
  37.5%
3
  30.0%
5
  50.0%
1
  25.0%
0
   0.0%
2
  50.0%
AST increased
0
   0.0%
0
   0.0%
3
  37.5%
5
  50.0%
1
  10.0%
2
  50.0%
3
  42.9%
3
  75.0%
Bilirubin increased
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
17.Primary Outcome
Title Part 2A: Number of Participants With Any Grade Change From Baseline in Liver Function Laboratory Parameters
Hide Description Blood samples were collected for the analysis of following liver function laboratory parameters: ALT, ALP, AST and bilirubin. The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
ALT increased
0
   0.0%
1
  20.0%
1
  10.0%
3
  25.0%
4
  28.6%
2
  16.7%
2
  16.7%
1
  25.0%
ALP increased
1
  20.0%
3
  60.0%
4
  40.0%
1
   8.3%
3
  21.4%
2
  16.7%
4
  33.3%
1
  25.0%
AST increased
1
  20.0%
3
  60.0%
2
  20.0%
1
   8.3%
6
  42.9%
3
  25.0%
3
  25.0%
1
  25.0%
Bilirubin increased
1
  20.0%
0
   0.0%
0
   0.0%
3
  25.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
18.Primary Outcome
Title Part 2B: Number of Participants With Any Grade Change From Baseline in Liver Function Laboratory Parameters
Hide Description Blood samples were collected for the analysis of following liver function laboratory parameters: ALT, ALP, AST and bilirubin. The laboratory parameters were graded according to NCI-CTCAE version 4. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
ALT increased
2
  22.2%
0
   0.0%
0
   0.0%
ALP increased
3
  33.3%
4
  50.0%
0
   0.0%
AST increased
3
  33.3%
0
   0.0%
0
   0.0%
Bilirubin increased
1
  11.1%
0
   0.0%
0
   0.0%
19.Primary Outcome
Title Part 1: Number of Participants With Any Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP were graded using NCI-CTCAE version 4. For SBP: Grade 0: <120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
SBP
0
   0.0%
1
 100.0%
6
  75.0%
3
  30.0%
5
  50.0%
2
  50.0%
6
  85.7%
3
  75.0%
DBP
0
   0.0%
0
   0.0%
4
  50.0%
5
  50.0%
5
  50.0%
2
  50.0%
2
  28.6%
2
  50.0%
20.Primary Outcome
Title Part 2A: Number of Participants With Any Grade Change From Baseline in SBP and DBP
Hide Description SBP and DBP were graded using NCI-CTCAE version 4. For SBP: Grade 0: <120 mmHg; Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
SBP
2
  40.0%
4
  80.0%
8
  80.0%
6
  50.0%
6
  42.9%
7
  58.3%
7
  58.3%
1
  25.0%
DBP
1
  20.0%
4
  80.0%
7
  70.0%
6
  50.0%
6
  42.9%
5
  41.7%
4
  33.3%
0
   0.0%
21.Primary Outcome
Title Part 2B: Number of Participants With Any Grade Change From Baseline in SBP and DBP
Hide Description SBP and DBP were graded using NCI-CTCAE version 4. For SBP: Grade 0: <120 mmHg; Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Any grade increase is defined as an increase in NCI-CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with any grade increase have been presented.
Time Frame Baseline (Day 1) and up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
SBP
7
  77.8%
4
  50.0%
4
  80.0%
DBP
5
  55.6%
5
  62.5%
3
  60.0%
22.Primary Outcome
Title Part 1: Number of Participants With Worst Case Change From Baseline in Heart Rate (HR)
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in heart rate is presented. Data was categorized as: heart rate 'decrease to low', 'increase to high' and 'change to normal or no change'; where low HR: <60 beats per minute [bpm]', normal HR: 60 to 100 bpm and high HR: >100 bpm. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
0
   0.0%
0
   0.0%
1
  12.5%
2
  20.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
Change to normal or no change
0
   0.0%
0
   0.0%
4
  50.0%
3
  30.0%
4
  40.0%
2
  50.0%
4
  57.1%
2
  50.0%
Increase to high
1
 100.0%
1
 100.0%
3
  37.5%
6
  60.0%
6
  60.0%
1
  25.0%
3
  42.9%
2
  50.0%
23.Primary Outcome
Title Part 2A: Number of Participants With Worst Case Change From Baseline in HR
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in heart rate is presented. Data was categorized as: heart rate 'decrease to low', 'increase to high' and 'change to normal or no change'; where low HR: <60 bpm', normal HR: 60 to 100 bpm and high HR: >100 bpm. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
0
   0.0%
0
   0.0%
1
  10.0%
3
  25.0%
4
  28.6%
1
   8.3%
3
  25.0%
0
   0.0%
Change to normal or no change
5
 100.0%
4
  80.0%
7
  70.0%
6
  50.0%
8
  57.1%
8
  66.7%
6
  50.0%
4
 100.0%
Increase to high
0
   0.0%
1
  20.0%
2
  20.0%
3
  25.0%
2
  14.3%
3
  25.0%
3
  25.0%
0
   0.0%
24.Primary Outcome
Title Part 2B: Number of Participants With Worst Case Change From Baseline in HR
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in heart rate is presented. Data was categorized as: heart rate 'decrease to low', 'increase to high' and 'change to normal or no change'; where low HR: <60 bpm', normal HR: 60 to 100 bpm and high HR: >100 bpm. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
2
  22.2%
1
  12.5%
0
   0.0%
Change to normal or no change
4
  44.4%
3
  37.5%
5
 100.0%
Increase to high
3
  33.3%
4
  50.0%
0
   0.0%
25.Primary Outcome
Title Part 1: Number of Participants With Worst Case Change From Baseline in Body Temperature
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in body temperature is presented. Data was categorized as: 'decrease to low', 'increase to high' and 'change to normal or no change'; where low body temperature: <=35 degrees Celsius, normal body temperature: 35 to 38 degrees Celsius and high body temperature: >=38 degrees Celsius. If values were unchanged (example: increase to >=38 degrees Celsius to increase to >=38 degrees Celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Change to normal or no change
1
 100.0%
1
 100.0%
8
 100.0%
8
  80.0%
9
  90.0%
3
  75.0%
7
 100.0%
4
 100.0%
Increase to high
0
   0.0%
0
   0.0%
0
   0.0%
2
  20.0%
1
  10.0%
1
  25.0%
0
   0.0%
0
   0.0%
26.Primary Outcome
Title Part 2A: Number of Participants With Worst Case Change From Baseline in Body Temperature
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in body temperature is presented. Data was categorized as: 'decrease to low', 'increase to high' and 'change to normal or no change'; where low body temperature: <=35 degrees Celsius, normal body temperature: 35 to 38 degrees Celsius and high body temperature: >=38 degrees Celsius. If values were unchanged (example: increase to >=38 degrees Celsius to increase to >=38 degrees Celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 5 10 12 14 12 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Change to normal or no change
4
  80.0%
5
 100.0%
10
 100.0%
11
  91.7%
12
  85.7%
12
 100.0%
12
 100.0%
4
 100.0%
Increase to high
1
  20.0%
0
   0.0%
0
   0.0%
1
   8.3%
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
27.Primary Outcome
Title Part 2B: Number of Participants With Worst Case Change From Baseline in Body Temperature
Hide Description Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date (Day 1). Change from Baseline was defined as post Baseline value minus Baseline value. Number of participants with worst case change from Baseline in body temperature is presented. Data was categorized as: 'decrease to low', 'increase to high' and 'change to normal or no change'; where low body temperature: <=35 degrees Celsius, normal body temperature: 35 to 38 degrees Celsius and high body temperature: >=38 degrees Celsius. If values were unchanged (example: increase to >=38 degrees Celsius to increase to >=38 degrees Celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to low' and 'increased to high' during post Baseline, so the percentages might not add to 100%.
Time Frame Baseline (Day 1) and up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
Change to normal or no change
9
 100.0%
8
 100.0%
5
 100.0%
Increase to high
0
   0.0%
0
   0.0%
0
   0.0%
28.Primary Outcome
Title Part 1: Number of Participants With Worst Case Post-Baseline Abnormal Clinically Significant Electrocardiogram (ECG) Findings
Hide Description A 12-lead ECG was obtained after the participant had rested at least 10 minutes in a semi-recumbent or supine position during the study using ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst case post Baseline abnormal clinical significant ECG findings are presented.
Time Frame Up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
29.Primary Outcome
Title Part 2A: Number of Participants With Worst Case Post-Baseline Abnormal Clinically Significant ECG Findings
Hide Description A 12-lead ECG was obtained after the participant had rested at least 10 minutes in a semi-recumbent or supine position during the study using ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst case post Baseline abnormal clinical significant ECG findings are presented.
Time Frame Up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated data points were analyzed.
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 4 3 10 10 12 10 11 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
30.Primary Outcome
Title Part 2B: Number of Participants With Worst Case Post-Baseline Abnormal Clinically Significant ECG Findings
Hide Description A 12-lead ECG was obtained after the participant had rested at least 10 minutes in a semi-recumbent or supine position during the study using ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with worst case post Baseline abnormal clinical significant ECG findings are presented.
Time Frame Up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at the indicated data points were analyzed.
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 4 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
31.Secondary Outcome
Title Part 1: Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or a partial response (PR) as the Best Overall Response (BOR), as assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30 percent (%) decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart.
Time Frame Up to maximum 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 0 0 0 0
32.Secondary Outcome
Title Part 2A: Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants achieving a confirmed CR or PR as the BOR, as assessed by the investigator per RECIST v 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30% decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart.
Time Frame Up to maximum 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. The efficacy outputs were presented according to planned study treatment. One participant in Part 2A was planned for 0.01mg, but received 0.003mg at first dose in error. One participant in Part 2A was planned for 0.003mg, but received 0.3mg at first dose in error. Hence, 'N' for the 'Part 2A: GSK3174998 0.01 mg/kg+Pembrolizumab 200 mg' arm is greater than that for the Participant Flow.
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 6 10 12 13 12 12 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 17 0 25 8 8 0 0
33.Secondary Outcome
Title Part 2B: Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants achieving a confirmed CR or PR as the BOR, as assessed by the investigator per RECIST v 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30% decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart.
Time Frame Up to maximum 33 weeks
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All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0
34.Secondary Outcome
Title Part 1: Disease Control Rate (DCR)
Hide Description DCR is defined as the percentage of participants with a confirmed CR or PR at any time, plus stable disease (SD) >=12 weeks as assessed by the investigator per RECIST v 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30% decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart. SD: 30% decrease in tumor burden compared with Baseline cannot be established nor 20% increase compared with nadir.
Time Frame Up to maximum 39 weeks
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Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 10 20 0 14 75
35.Secondary Outcome
Title Part 2A: Disease Control Rate (DCR)
Hide Description DCR is defined as the percentage of participants with a confirmed CR or PR at any time, plus SD >=12 weeks as assessed by the investigator per RECIST v 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30% decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart. SD: 30% decrease in tumor burden compared with Baseline cannot be established nor 20% increase compared with nadir.
Time Frame Up to maximum 105 weeks
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Hide Analysis Population Description
All Treated Population. The efficacy outputs were presented according to planned study treatment. One participant in Part 2A was planned for 0.01mg, but received 0.003mg at first dose in error. One participant in Part 2A was planned for 0.003mg, but received 0.3mg at first dose in error. Hence, 'N' for the 'Part 2A: GSK3174998 0.01 mg/kg+Pembrolizumab 200 mg' arm is greater than that for the Participant Flow.
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 5 6 10 12 13 12 12 4
Measure Type: Number
Unit of Measure: Percentage of participants
0 33 0 50 23 50 58 0
36.Secondary Outcome
Title Part 2B: Disease Control Rate (DCR)
Hide Description DCR is defined as the percentage of participants with a confirmed CR or PR at any time, plus SD >=12 weeks as assessed by the investigator per RECIST v 1.1 criteria. CR: Disappearance of all lesions in two consecutive observations not less than 4 weeks apart. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR: >=30% decrease in tumor burden compared with Baseline in two observations at least 4 weeks apart. SD: 30% decrease in tumor burden compared with Baseline cannot be established nor 20% increase compared with nadir.
Time Frame Up to maximum 33 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with non-small cell lung cancer (NSCLC) were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Overall Number of Participants Analyzed 9 8 5
Measure Type: Number
Unit of Measure: Percentage of participants
11 0 60
37.Secondary Outcome
Title Part 1: Plasma Concentrations of GSK3174998 at Indicated Time Points
Hide Description Blood samples for pharmacokinetic (PK) analysis of GSK3174998 were collected on Days 1, 22: Pre-dose and within 30 minutes, 4 hour, 24 hour after end of GSK3174998 infusion (EOI); anytime on Days 8, 15, 29 and 36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion.
Time Frame Days 1, 22: Pre-dose and within 30 minutes, 4 hours, 24 hours after end of GSK3174998 infusion; anytime on Days 8,15,29,36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion
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Hide Analysis Population Description
Pharmacokinetic Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the indicated data points were analyzed (represented by n=X in category titles).
Arm/Group Title Part 1: GSK3174998 0.003 mg/kg Part 1: GSK3174998 0.01 mg/kg Part 1: GSK3174998 0.03 mg/kg Part 1: GSK3174998 0.1 mg/kg Part 1: GSK3174998 0.3 mg/kg Part 1: GSK3174998 1.0 mg/kg Part 1: GSK3174998 3.0 mg/kg Part 1: GSK3174998 10.0 mg/kg
Hide Arm/Group Description:
Participants received intravenous (IV) dose of GSK3174998 0.003 milligram per kilogram (mg/kg) every 3 weeks (wks) in Part 1.
Participants received IV dose of GSK3174998 0.01 mg/kg every 3 weeks (Q3W) in Part 1.
Participants received IV dose of GSK3174998 0.03 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.1 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 0.3 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 1.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 3.0 mg/kg Q3W in Part 1.
Participants received IV dose of GSK3174998 10.0 mg/kg Q3W in Part 1.
Overall Number of Participants Analyzed 1 1 8 10 10 4 7 4
Mean (Standard Deviation)
Unit of Measure: Micrograms per milliliter
Day 1, predose, n=1,1,8,10,10,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 0.000  (0.0000) 0.001  (0.0033) 0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000)
Day1, 30minutes after EOI, n=1,1,8,10,10,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants
0.044 [1]   (NA) 0.181 [1]   (NA) 0.893  (0.3505) 2.958  (1.1359) 6.091  (1.6075) 23.224  (5.2813) 77.500  (17.8619) 277.615  (30.9564)
Day1, 4hour after EOI, n=1,1,8,10,9,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 9 participants 4 participants 7 participants 4 participants
0.021 [1]   (NA) 0.140 [1]   (NA) 0.809  (0.3205) 2.668  (1.0513) 5.615  (1.3647) 21.533  (5.5070) 70.603  (15.1388) 243.701  (42.5698)
Day1, 24hour after EOI, n=1,1,6,10,9,4,7,4 Number Analyzed 1 participants 1 participants 6 participants 10 participants 9 participants 4 participants 7 participants 4 participants
0.000 [1]   (NA) 0.083 [1]   (NA) 0.564  (0.2508) 2.080  (0.9446) 4.954  (1.2600) 17.645  (3.8210) 59.143  (12.1864) 191.862  (35.7293)
Day 8, n=1,1,8,10,10,3,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 3 participants 7 participants 4 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 0.122  (0.0926) 0.678  (0.4251) 1.932  (0.3732) 9.675  (2.9619) 32.974  (8.4840) 108.278  (44.5563)
Day 14, n=1,1,8,9,10,3,7,4 Number Analyzed 1 participants 1 participants 8 participants 9 participants 10 participants 3 participants 7 participants 4 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 0.022  (0.0412) 0.190  (0.1577) 1.205  (0.2799) 5.303  (1.9430) 21.705  (6.4334) 80.909  (27.3394)
Day 22, predose, n=1,1,8,10,10,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 0.003  (0.0087) 0.026  (0.0529) 0.605  (0.2412) 2.826  (2.1396) 15.185  (4.1187) 58.537  (17.2736)
Day22, 30minutes after EOI, n=1,1,8,10,10,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants
0.043 [1]   (NA) 0.174 [1]   (NA) 0.619  (0.2229) 2.579  (0.4762) 7.256  (1.8199) 25.859  (9.2995) 81.115  (32.5472) 321.132  (40.4375)
Day22, 4hour after EOI, n=1,1,8,10,9,4,7,4 Number Analyzed 1 participants 1 participants 8 participants 10 participants 9 participants 4 participants 7 participants 4 participants
0.038 [1]   (NA) 0.149 [1]   (NA) 0.523  (0.1963) 2.301  (0.4088) 6.519  (1.5717) 22.905  (9.6502) 82.690  (18.1793) 306.585  (31.7702)
Day22, 24hour after EOI, n=1,0,6,9,9,4,7,4 Number Analyzed 1 participants 0 participants 6 participants 9 participants 9 participants 4 participants 7 participants 4 participants
0.012 [1]   (NA) 0.319  (0.1676) 1.711  (0.4435) 4.933  (0.8727) 17.869  (9.3910) 72.801  (17.5925) 260.830  (44.1526)
Day 29, n=0,1,8,10,10,4,7,4 Number Analyzed 0 participants 1 participants 8 participants 10 participants 10 participants 4 participants 7 participants 4 participants
0.000 [1]   (NA) 0.037  (0.0663) 0.380  (0.2882) 2.243  (0.8667) 8.654  (5.9929) 42.013  (13.3448) 153.655  (37.5871)
Day 36, n=0,1,7,9,9,4,6,4 Number Analyzed 0 participants 1 participants 7 participants 9 participants 9 participants 4 participants 6 participants 4 participants
0.000 [1]   (NA) 0.013  (0.0313) 0.115  (0.1114) 1.227  (0.4101) 6.428  (4.5933) 31.093  (10.5909) 111.545  (22.8298)
Day 43, predose, n=0,1,6,8,9,4,5,3 Number Analyzed 0 participants 1 participants 6 participants 8 participants 9 participants 4 participants 5 participants 3 participants
0.000 [1]   (NA) 0.003  (0.0064) 0.023  (0.0355) 0.832  (0.5269) 4.789  (3.2591) 21.658  (8.9413) 82.723  (26.1829)
Day43, 30minutes after EOI, n=0,1,6,7,9,3,5,3 Number Analyzed 0 participants 1 participants 6 participants 7 participants 9 participants 3 participants 5 participants 3 participants
0.267 [1]   (NA) 0.547  (0.5929) 2.130  (1.4403) 7.373  (2.3810) 30.602  (0.6521) 95.775  (22.9300) 302.882  (3.7341)
Day 64, predose, n=0,1,5,5,7,4,4,3 Number Analyzed 0 participants 1 participants 5 participants 5 participants 7 participants 4 participants 4 participants 3 participants
0.000 [1]   (NA) 0.023  (0.0520) 0.014  (0.0206) 1.097  (0.4744) 5.747  (3.8915) 23.922  (9.6447) 76.602  (27.6046)
Day64, 30minutes after EOI, n=0,0,5,5,7,4,4,2 Number Analyzed 0 participants 0 participants 5 participants 5 participants 7 participants 4 participants 4 participants 2 participants
0.339  (0.4499) 1.154  (1.2985) 7.952  (2.7538) 21.941  (15.0801) 98.410  (19.0269) 312.277  (61.0388)
Day 85, predose, n=0,0,1,4,3,2,2,3 Number Analyzed 0 participants 0 participants 1 participants 4 participants 3 participants 2 participants 2 participants 3 participants
0.000 [1]   (NA) 0.023  (0.0315) 1.227  (0.7462) 8.518  (0.6700) 22.635  (3.1816) 83.090  (31.8311)
Day85, 30minutes after EOI, n=0,0,1,4,3,2,2,3 Number Analyzed 0 participants 0 participants 1 participants 4 participants 3 participants 2 participants 2 participants 3 participants
0.000 [1]   (NA) 1.246  (1.3975) 9.421  (1.8598) 32.824  (0.4611) 82.402  (18.5192) 294.788  (15.9947)
Day106, predose, n=0,0,1,1,2,2,1,2 Number Analyzed 0 participants 0 participants 1 participants 1 participants 2 participants 2 participants 1 participants 2 participants
0.000 [1]   (NA) 0.000 [1]   (NA) 1.323  (0.2234) 8.497  (0.5922) 19.047 [1]   (NA) 94.359  (11.4639)
Day106, 30minutes after EOI, n=0,0,0,1,3,2,1,2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 3 participants 2 participants 1 participants 2 participants
1.591 [1]   (NA) 8.377  (0.3270) 33.406  (6.3673) 79.852 [1]   (NA) 307.222  (3.5048)
[1]
Standard deviation could not be calculated due to single participant
38.Secondary Outcome
Title Part 2A: Plasma Concentrations of GSK3174998 at Indicated Time Points
Hide Description Blood samples for PK analysis of GSK3174998 were collected on Days 1, 22: Pre-dose and within 30 minutes, 4 hour, 24 hour after end of GSK3174998 infusion (EOI); anytime on Days 8, 15, 29 and 36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion.
Time Frame Days 1, 22: Pre-dose and within 30 minutes, 4 hours, 24 hours after end of GSK3174998 infusion; anytime on Days 8,15,29,36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion
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Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the indicated data points were analyzed (represented by n=X in category titles).
Arm/Group Title Part 2A: GSK3174998 0.003 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.01 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.03 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.1 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 0.3 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 1.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 3.0 mg/kg + Pembrolizumab 200 mg Part 2A: GSK3174998 10.0 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants received IV dose of GSK3174998 0.003 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.01 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.03 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.1 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 1.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 3.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Participants received IV dose of GSK3174998 10.0 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2A.
Overall Number of Participants Analyzed 4 5 10 11 14 11 12 4
Mean (Standard Deviation)
Unit of Measure: Micrograms per milliliter
Day 1, predose, n=4,5,9,10,11,11,12,4 Number Analyzed 4 participants 5 participants 9 participants 10 participants 11 participants 11 participants 12 participants 4 participants
0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000) 0.928  (3.0764) 0.000  (0.0000) 0.000  (0.0000)
Day1, 30minutes after EOI, n=4,5,9,10,11,11,12,4 Number Analyzed 4 participants 5 participants 9 participants 10 participants 11 participants 11 participants 12 participants 4 participants
0.051  (0.0212) 0.235  (0.0971) 0.833  (0.5313) 2.088  (0.8049) 6.542  (2.1648) 25.623  (6.4576) 70.550  (16.4984) 193.082  (30.6483)
Day1, 4hour after EOI, n=4,5,9,10,11,11,12,4 Number Analyzed 4 participants 5 participants 9 participants 10 participants 11 participants 11 participants 12 participants 4 participants
0.038  (0.0263) 0.215  (0.0396) 0.762  (0.4730) 2.160  (1.0232) 5.819  (1.6015) 23.367  (4.5233) 66.831  (17.5167) 178.023  (20.6597)
Day1, 24hour after EOI, n=4,5,9,10,11,11,12,4 Number Analyzed 4 participants 5 participants 9 participants 10 participants 11 participants 11 participants 12 participants 4 participants
0.010  (0.0125) 0.112  (0.0599) 0.578  (0.4049) 1.644  (0.7086) 5.084  (1.7161) 19.398  (5.6732) 55.782  (13.0007) 140.747  (9.5100)
Day 8, n=4,5,10,11,14,11,12,4 Number Analyzed 4 participants 5 participants 10 participants 11 participants 14 participants 11 participants 12 participants 4 participants
0.000  (0.0000) 0.000  (0.0000) 0.428  (0.9836) 0.592  (0.3233) 2.203  (0.7619) 12.151  (8.5380) 30.442  (8.6063) 71.830  (14.1731)
Day 15, n=4,4,10,10,12,11,12,4 Number Analyzed 4 participants 4 participants 10 participants 10 participants 12 participants 11 participants 12 participants 4 participants
0.000  (0.0000) 0.000  (0.0000) 0.257  (0.7547) 0.200  (0.1821) 1.357  (0.7574) 8.458  (8.3133) 22.050  (6.8631) 50.342  (12.5709)
Day 22, predose, n=3,2,10,10,12,10,12,3 Number Analyzed 3 participants 2 participants 10 participants 10 participants 12 participants 10 participants 12 participants 3 participants
0.000  (0.0000) 0.000  (0.0000) 0.106  (0.3359) 0.080  (0.0880) 0.626  (0.3716) 6.912  (7.0973) 16.354  (5.5789) 31.882  (12.4466)
Day22, 30minutes after EOI, n=3,2,10,10,12,9,12,3 Number Analyzed 3 participants 2 participants 10 participants 10 participants 12 participants 9 participants 12 participants 3 participants
0.080  (0.0350) 0.879  (0.8898) 0.754  (0.4533) 2.343  (0.5196) 7.496  (2.7519) 30.238  (4.8782) 85.882  (16.2709) 222.118  (45.7084)
Day22, 4hour after EOI, n=3,2,9,10,12,9,12,3 Number Analyzed 3 participants 2 participants 9 participants 10 participants 12 participants 9 participants 12 participants 3 participants
0.052  (0.0406) 0.682  (0.6743) 0.704  (0.4011) 2.203  (0.4515) 6.938  (2.6934) 27.273  (6.0059) 82.796  (16.8542) 205.085  (26.1667)
Day22, 24hour after EOI, n=3,2,7,7,9,10,12,3 Number Analyzed 3 participants 2 participants 7 participants 7 participants 9 participants 10 participants 12 participants 3 participants
0.011  (0.0188) 0.365  (0.3729) 0.628  (0.3755) 1.702  (0.3438) 6.015  (2.6501) 21.631  (8.6914) 69.978  (13.9446) 164.798  (36.7704)
Day 29, n=3,1,9,10,10,10,12,1 Number Analyzed 3 participants 1 participants 9 participants 10 participants 10 participants 10 participants 12 participants 1 participants
0.000  (0.0000) 0.045 [1]   (NA) 0.134  (0.2410) 0.607  (0.3352) 2.682  (1.5569) 11.961  (5.5511) 45.527  (14.7008) 67.369 [1]   (NA)
Day 36, n=3,2,8,8,8,10,11,1 Number Analyzed 3 participants 2 participants 8 participants 8 participants 8 participants 10 participants 11 participants 1 participants
0.000  (0.0000) 0.000  (0.0000) 0.019  (0.0404) 0.243  (0.2081) 1.994  (1.2562) 9.146  (4.7873) 33.671  (10.9055) 106.605 [1]   (NA)
Day 43, predose, n=3,3,7,7,8,9,12,1 Number Analyzed 3 participants 3 participants 7 participants 7 participants 8 participants 9 participants 12 participants 1 participants
0.000  (0.0000) 0.000  (0.0000) 0.000  (0.0000) 0.071  (0.1213) 0.950  (0.6068) 7.207  (2.1852) 24.578  (8.5351) 74.088 [1]   (NA)
Day43, 30minutes after EOI, n=3,3,7,7,8,8,12,1 Number Analyzed 3 participants 3 participants 7 participants 7 participants 8 participants 8 participants 12 participants 1 participants
0.071  (0.0156) 0.229  (0.0379) 0.496  (0.2657) 1.922  (0.8919) 7.639  (2.1641) 28.433  (5.1446) 94.463  (20.9570) 377.078 [1]   (NA)
Day 64, predose, n=1,3,2,6,4,8,10,0 Number Analyzed 1 participants 3 participants 2 participants 6 participants 4 participants 8 participants 10 participants 0 participants
0.000 [1]   (NA) 0.000  (0.0000) 0.000  (0.0000) 0.067  (0.1145) 0.706  (0.8655) 8.349  (2.7499) 32.716  (11.1159)
Day64, 30minutes after EOI, n=1,3,2,7,4,8,10,0 Number Analyzed 1 participants 3 participants 2 participants 7 participants 4 participants 8 participants 10 participants 0 participants
0.067 [1]   (NA) 0.245  (0.0932) 0.284  (0.4014) 2.152  (1.3890) 6.032  (3.2357) 33.382  (5.0217) 99.623  (25.2220)
Day 85, predose, n=0,3,0,5,5,7,8,0 Number Analyzed 0 participants 3 participants 0 participants 5 participants 5 participants 7 participants 8 participants 0 participants
0.000  (0.0000) 0.115  (0.1528) 0.938  (0.9332) 10.323  (3.5051) 35.166  (13.8402)
Day85, 30minutes after EOI, n=0,3,0,5,5,7,8,0 Number Analyzed 0 participants 3 participants 0 participants 5 participants 5 participants 7 participants 8 participants 0 participants
0.228  (0.0996) 2.275  (1.2464) 7.734  (2.5853) 34.982  (6.5978) 100.514  (26.7950)
Day106, predose, n=0,1,0,5,5,5,8,0 Number Analyzed 0 participants 1 participants 0 participants 5 participants 5 participants 5 participants 8 participants 0 participants
0.000 [1]   (NA) 0.184  (0.1858) 0.647  (0.8249) 10.395  (5.5838) 36.990  (16.0967)
Day106, 30minutes after EOI, n=0,1,0,5,4,5,8,0 Number Analyzed 0 participants 1 participants 0 participants 5 participants 4 participants 5 participants 8 participants 0 participants
0.269 [1]   (NA) 2.477  (0.8254) 8.218  (3.9343) 33.183  (6.7012) 108.103  (29.3324)
[1]
Standard deviation could not be calculated due to single participant
39.Secondary Outcome
Title Part 2B: Plasma Concentrations of GSK3174998 at Indicated Time Points
Hide Description Blood samples for PK analysis of GSK3174998 were collected on Days 1, 22: Pre-dose and within 30 minutes, 4 hour, 24 hour after end of GSK3174998 infusion (EOI); anytime on Days 8, 15, 29 and 36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion.
Time Frame Days 1, 22: Pre-dose and within 30 minutes, 4 hours, 24 hours after end of GSK3174998 infusion; anytime on Days 8,15,29,36; Days 43, 64, 85, 106: Pre-dose and within 30 minutes after end of GSK3174998 infusion
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Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the indicated data points were analyzed (represented by n=X in category titles).
Arm/Group Title Part 2B: Melanoma Cohort Part 2B: Soft Tissue Sarcoma Cohort Part 2B: NSCLC Cohort
Hide Arm/Group Description:
Participants with melanoma were included in this cohort and received IV dose of GSK3174998 0.3 mg/kg + pembrolizumab 200 mg IV Q3W in Part 2B.
Participants with soft tissue sarcoma were included in this cohort and received IV dose of GSK31749