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Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors

A Phase I, Open-Label Study of GSK1795091 Administered in Combination With Immunotherapies in Participants With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03447314
Enrollment
54
Registered
2018-02-27
Start date
2018-03-26
Completion date
2022-03-11
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

pembrolizumab, GSK1795091, Dose-escalation, 204686, Immunotherapies, GSK3359609, Phase I, anticancer agent, OX40, 201212, 204691, ICOS, TLR4, GSK3174998, Advanced Solid Tumors

Brief summary

GSK1795091 is being developed for administration in combination with other immune system modulators for the treatment of cancers. The study will be conducted in two parts. In Part 1, dose escalation will be performed to identify combination dose levels comprising GSK1795091 with either 24 milligrams (mg) GSK3174998 (Part 1a), 80 mg GSK3359609 (Part 1b), or 200 mg pembrolizumab (Part 1c). One dose level of GSK3174998, GSK3359609, or pembrolizumab with up to 5 dose levels of GSK1795091 are planned for evaluation. In Part 2 (dose-expansion), subjects will receive a single dose level of GSK1795091 as identified based on data from Part 1, in combination with either GSK3174998, GSK3359609, or pembrolizumab.

Interventions

GSK1795091 will be available as solution for injection

GSK3174998 will be available as lyophilized powder to be reconstituted for infusion.

DRUGGSK3359609

GSK3359609 will be available as solution for infusion.

DRUGPembrolizumab

Pembrolizumab will be available as solution for infusion or lyophilized powder for reconstitution.

Sponsors

Iqvia Pty Ltd
CollaboratorINDUSTRY
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

In Part 1, one dose level of GSK3174998, GSK3359609, or pembrolizumab with up to 5 dose levels of GSK1795091 are planned for evaluation. Sequential cohorts will be enrolled and dose escalation (or de-escalation) will proceed according to Neuenschwander-Continual Reassessment Method (N-CRM design). In Part 2, subjects will be administered GSK1795091 in combination with either 24 mg GSK3174998, 80 mg GSK3359609, or 200 mg pembrolizumab at a dose identified in Part 1.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject must be \>=18 years of at the time of signing the informed consent. * Histological documentation of advanced solid tumor. * Archival tumor tissue obtained at any time from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. Subjects enrolled in a PK/Pharmacodynamic Cohort must provide a fresh biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy. * Disease that has progressed after standard therapies or for which standard therapy is otherwise unsuitable (example, intolerance). * Measurable disease, that is, presenting with at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Life expectancy of at least 12 weeks. * Adequate organ function. * In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. * Male or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b). A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions specified. Additional Inclusion criteria for Subjects in Part 2a (GSK3174998 expansion) and Part 2b (GSK3359609 expansion): * Histological or cytological documentation of squamous cell carcinoma of the head and neck (SCCHN) (oral cavity, oropharynx, hypopharynx, or larynx) that is recurrent, locally advanced, or metastatic and is not amenable to curative treatment options, surgery or definitive chemoradiation therapy. * Received, ineligible for, or otherwise unsuitable for platinum-based therapy and anti-Programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy * Received no more than 3 prior lines of systemic therapy for metastatic disease. Additional Inclusion Criteria for Subjects in Part 2c (pembrolizumab expansion): * Histological or cytological documentation of SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) that is recurrent, locally advanced, or metastatic and is not amenable to curative treatment options, surgery or definitive chemoradiation therapy. * Received no more than 2 prior lines of systemic therapy for metastatic disease.

Exclusion criteria

* Malignancy other than disease under study with the exception of those from which the subject has been disease-free for more than 2 years and not expected to affect the safety of the subject or the endpoints of the trial. * Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment. * Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years. Replacement therapy (example, thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted. * Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment. * Known human immunodeficiency virus infection. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study treatment. * Positive Hepatitis C test result at screening or within 3 months prior to first dose of study treatment. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec) or QTcF \>480 msec for subjects with bundle branch block * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Recent history of allergen desensitization therapy within 4 weeks of starting study treatment. * History of severe hypersensitivity to monoclonal antibodies (mAbs). * History or evidence of cardiovascular (CV) risk including any of the following: a) Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third degree atrioventricular block. b) Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment. c) Congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association (NYHA) functional classification system. d) Recent (within the past 6 months) history of symptomatic pericarditis. * History of idiopathic pulmonary fibrosis, pneumonitis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures. * Is or has an immediate family member (example, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific subject. * Prior treatment with the following agents: a) OX40, inducible T-cell co-stimulator (ICOS) agonist at any time. b) Prior systemic or intratumoral therapy with TLR agonist. c) Anticancer therapy or investigational therapy within 30 days or 5 half-lives of the drug, whichever is shorter. d) Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 14 days before start of study treatment for radiation of any intended use to the extremities for bone metastases and 28 days for radiation to the chest, brain, or visceral organs is required. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Toxicity from previous treatment including: a) Toxicity Grade \>=3 related to prior immunotherapy and that lead to study treatment discontinuation. b) Toxicity related to prior treatment has not resolved to Grade \<=1 (except alopecia, or endocrinopathy managed with replacement therapy). * Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor, and recombinant erythropoietin) within 2 weeks before the first dose of study treatment. * Major surgery \<=4 weeks before the first dose of study treatment. Subjects must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Known drug or alcohol abuse. * Receipt of any live vaccine within 4 weeks. Additional

Design outcomes

Primary

MeasureTime frameDescription
Part 2: Number of Participants With Vital Signs Any Increases From Baseline According to Markedly Abnormal CriteriaUp to 2 yearsVital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Part 2: Number of Participants With Any QTcF Interval Increases From Baseline According to Markedly Abnormal CriteriaUp to 2 years12-lead ECG was planned to be performed to measure QTcF interval.
Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal CriteriaUp to 2 years12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (\>450 milliseconds \[msec\]), Grade 2 (\>480 msec), Grade 3 (\>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented.
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaUp to 2 yearsVital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (\>140 and \<161 millimeter of mercury\[mmHg\]), Category 2 (\>=161 and \<181 mmHg), Category3 (\>=181 mmHg); DBP: Category1 (\>90 and \<101 mmHg), Category 2 (\>=101 and \<111 mmHg), Category 3 (\>=111 mmHg); PR: Category 1 (\>101 and \<116 beats per minutes\[bpm\]), Category 2 (\>=116 and \<131 bpm), Category 3 (\>=131 bpm); BT: Category 1 (\>38.0 and \<38.6 degrees Celsius), Category 2 (\>=38.6 and \<39.1 degrees Celsius), Category 3 (\>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented.
Part 2: Number of Participants With Vital Signs Any Decreases From Baseline According to Markedly Abnormal CriteriaUp to 2 yearsVital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaUp to 2 yearsVital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as \<80 mmHg decrease from Baseline; DBP: decrease defined as Category (\<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (\<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)Up to 27 monthsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.
Part 2: Number of Participants With TEAEs and STEAEsUp to 27 monthsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 1: Number of Participants With Dose-limiting Toxicity (DLT)42 daysAn adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of \>7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to \<=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) \>=5 times upper limit of normal (ULN), ALT \>=3 times ULN persists for \>=4 weeks, ALT \>=3 times ULN and bilirubin \>=2 times ULN (\>35 percent \[%\] direct bilirubin), ALT \>=3 times ULN and international normalized ratio (INR) \>1.5, ALT \>=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity.
Part 1: Number of Participants With TEAEs Leading to DiscontinuationUp to 2 yearsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 2: Number of Participants With TEAEs Leading to DiscontinuationUp to 2 yearsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose DelaysUp to 2 yearsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 2: Number of Participants With TEAEs Leading to Dose Reductions or Dose DelaysUp to 2 yearsAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaseline (Day 1: Pre-dose) and up to 2 yearsBlood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range \[LNR\]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Part 2: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaseline (Day 1: Pre-dose) and up to 2 yearsBlood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count.
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBaseline (Day 1: Pre-dose) and up to 2 yearsBlood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented.
Part 2: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBaseline (Day 1: Pre-dose) and up to 2 yearsBlood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance.
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaUp to 2 yearsUrine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaUp to 2 yearsUrine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method.

Secondary

MeasureTime frameDescription
Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Part 1b: AUC(0-tau) GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Part 1c: AUC(0-tau) GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Part 1a: Predose Concentration (Cpre) of GSK1795091Days 1, 8, 15, 22, 57, 64, 78, 162, 246, 414 and 498: Pre-doseBlood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Part 1b: Cpre of GSK1795091Days 1, 8, 15, 22, 57, 64 and 78: Pre-doseBlood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Part 1c: Cpre of GSK1795091Days 1, 8, 15, 22, 57, 64 and 78: Pre-doseBlood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998Up to 27 monthsSerum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 1b: Number of Participants With the Present ADA Against GSK3359609Up to 27 monthsSerum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 1c: Number of Participants With the Present ADA Against PembrolizumabUp to 27 monthsSerum samples were collected at indicated time points for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were planned to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 2b: Number of Participants With the Present ADA Against GSK3359609Up to 2 yearsSerum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 2c: Number of Participants With the Present ADA Against PembrolizumabUp to 2 yearsSerum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 2a: Number of Participants With the Present ADA Against GSK3174998Up to 2 yearsSerum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part 1: Objective Response RateUp to 47 months and 13 daysObjective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part 2: Objective Response RateUp to 47 months and 13 daysObjective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part 1: Disease Control RateUp to 47 months and 13 daysDisease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Part 2: Disease Control RateUp to 47 months and 13 daysDisease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Part 1: Time to ResponseUp to 47 months and 13 daysTime to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Part 2: Time to ResponseUp to 47 months and 13 daysTime to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Part 1: Duration of ResponseUp to 47 months and 13 daysDuration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Part 2: Duration of ResponseUp to 47 months and 13 daysDuration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Part 1: Progression-free SurvivalUp to 47 months and 13 daysProgression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. PFS was determined according to RECIST version 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Part 2: Progression-free SurvivalUp to 47 months and 13 daysProgression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest by RECIST v 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Part 1: Overall SurvivalUp to 47 months and 13 daysOverall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Part 2: Overall SurvivalUp to 47 months and 13 daysOverall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. Pharmacokinetic (PK) Population consisted of all participants from the All Treated population for whom a PK sample was obtained, analyzed, measurable, and valid.
Part 1b: Plasma Concentration of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Part 1c: Plasma Concentration of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Part 1b: Cmax of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Part 1c: Cmax of GSK1795091Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-doseBlood samples were collected at indicated time points for the determination of Cmax of GSK1795091.

Other

MeasureTime frameDescription
Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyUp to 47 months and 13 daysAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersUp to 2 yearsBlood samples were planned to be collected for the analysis of following chemistry parameters: albumin, ALP, ALT, AST, bilirubin, calcium, creatinine, glucose, potassium and sodium.
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersUp to 2 yearsBlood samples were collected for the analysis of following chemistry parameters: albumin (Hypo), ALP, ALT, AST, bilirubin, calcium (Hyper and Hypo), creatinine, glucose (Hyper and Hypo), potassium (Hyper and Hypo) and sodium (Hyper and Hypo). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersUp to 2 yearsBlood samples were planned to be collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), hemoglobin (Hb) and platelet count (PC).
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersUp to 2 yearsBlood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho) (Low), hemoglobin (Hb) (Low) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Part 2: Number of Participants With TEAEs and STEAEs Until End of the StudyUp to 47 months and 13 daysAn adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Countries

Canada, Netherlands, Spain, United States

Participant flow

Recruitment details

This was a non-randomized, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors.

Pre-assignment details

Total 54 participants were enrolled in the study. GSK1795091 150 nanograms (ng), 200 and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to manufacturing issue. Part 2 was not initiated.

Participants by arm

ArmCount
Part 1a: 50ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
9
Part 1a: 100ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
6
Part 1a: 150ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
9
Part 1a: 200ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
4
Part 1a: 250ng GSK1795091 + 24mg GSK3174998
Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval.
2
Part 1b: 50ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
6
Part 1b: 100ng GSK1795091 + 80mg GSK3359609
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval.
5
Part 1b: 150ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
0
Part 1b: 200ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
0
Part 1b: 250ng GSK1795091 + 80mg GSK3359609
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval.
0
Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
7
Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab
Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval.
6
Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
0
Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
0
Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab
Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval.
0
Part 2a: GSK1795091 + 24 mg GSK3174998
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
0
Part 2b: GSK1795091 + 80 mg GSK3359609
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
0
Part 2c: GSK1795091 + 200 mg Pembrolizumab
Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
0
Total54

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016FG017
Part 1 (Up to 47 Months and 13 Days)Death654314200043000000
Part 1 (Up to 47 Months and 13 Days)Disease progression001000000000000000
Part 1 (Up to 47 Months and 13 Days)Investigator discretion000101000000000000
Part 1 (Up to 47 Months and 13 Days)Lost to Follow-up001000000000000000
Part 1 (Up to 47 Months and 13 Days)Reason for discontinuation was not recorded in the case report form000000000010000000
Part 1 (Up to 47 Months and 13 Days)Withdrawal by Subject101001100000000000

Baseline characteristics

CharacteristicPart 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: 150ng GSK1795091 + 80mg GSK3359609Part 1b: 200ng GSK1795091 + 80mg GSK3359609Part 1b: 250ng GSK1795091 + 80mg GSK3359609Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1c: 150ng GSK1795091 + 200mg PembrolizumabPart 1c: 200ng GSK1795091 + 200mg PembrolizumabPart 1c: 250ng GSK1795091 + 200mg PembrolizumabPart 2a: GSK1795091 + 24 mg GSK3174998Part 2b: GSK1795091 + 80 mg GSK3359609Part 2c: GSK1795091 + 200 mg PembrolizumabTotal
Age, Customized
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
19 - 64 years
8 Participants7 Participants3 Participants0 Participants5 Participants4 Participants3 Participants0 Participants0 Participants0 Participants4 Participants3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants37 Participants
Age, Customized
>=65 years
1 Participants2 Participants1 Participants2 Participants1 Participants1 Participants3 Participants0 Participants0 Participants0 Participants3 Participants3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants17 Participants
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Asian - East Asian Heritage
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Unknown
2 Participants2 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants5 Participants
Race/Ethnicity, Customized
White - Arabic/North African Heritage
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
6 Participants7 Participants4 Participants2 Participants5 Participants5 Participants6 Participants0 Participants0 Participants0 Participants6 Participants5 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants46 Participants
Sex: Female, Male
Female
4 Participants3 Participants2 Participants0 Participants4 Participants3 Participants3 Participants0 Participants0 Participants0 Participants5 Participants4 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants28 Participants
Sex: Female, Male
Male
5 Participants6 Participants2 Participants2 Participants2 Participants2 Participants3 Participants0 Participants0 Participants0 Participants2 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
6 / 95 / 64 / 94 / 41 / 25 / 63 / 54 / 73 / 6
other
Total, other adverse events
9 / 96 / 69 / 94 / 41 / 26 / 65 / 55 / 75 / 6
serious
Total, serious adverse events
1 / 92 / 65 / 91 / 40 / 22 / 62 / 53 / 72 / 6

Outcome results

Primary

Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria

Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as \<80 mmHg decrease from Baseline; DBP: decrease defined as Category (\<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (\<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP2 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP1 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP1 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate1 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, DBP0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, Pulse rate0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal CriteriaAny decrease, SBP0 Participants
Primary

Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria

12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (\>450 milliseconds \[msec\]), Grade 2 (\>480 msec), Grade 3 (\>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented.

Time frame: Up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria2 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria1 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria2 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria3 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria1 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria1 Participants
Primary

Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range

Blood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented.

Time frame: Baseline (Day 1: Pre-dose) and up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeD.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeGlu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeBil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangePot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeSod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeCr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeAlb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeUrea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal RangeProtein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Primary

Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range

Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range \[LNR\]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.

Time frame: Baseline (Day 1: Pre-dose) and up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeBaso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeMono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeNeutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeHb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangePC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeLympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeErythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal RangeEMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Primary

Part 1: Number of Participants With Dose-limiting Toxicity (DLT)

An adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of \>7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to \<=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) \>=5 times upper limit of normal (ULN), ALT \>=3 times ULN persists for \>=4 weeks, ALT \>=3 times ULN and bilirubin \>=2 times ULN (\>35 percent \[%\] direct bilirubin), ALT \>=3 times ULN and international normalized ratio (INR) \>1.5, ALT \>=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity.

Time frame: 42 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Dose-limiting Toxicity (DLT)1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Dose-limiting Toxicity (DLT)0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Dose-limiting Toxicity (DLT)1 Participants
Primary

Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria

Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (\>140 and \<161 millimeter of mercury\[mmHg\]), Category 2 (\>=161 and \<181 mmHg), Category3 (\>=181 mmHg); DBP: Category1 (\>90 and \<101 mmHg), Category 2 (\>=101 and \<111 mmHg), Category 3 (\>=111 mmHg); PR: Category 1 (\>101 and \<116 beats per minutes\[bpm\]), Category 2 (\>=116 and \<131 bpm), Category 3 (\>=131 bpm); BT: Category 1 (\>38.0 and \<38.6 degrees Celsius), Category 2 (\>=38.6 and \<39.1 degrees Celsius), Category 3 (\>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP7 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature1 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate2 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP3 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate1 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP3 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP6 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature2 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate4 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP3 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP1 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP1 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate1 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP0 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate2 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP2 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP0 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP2 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature1 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate1 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, DBP3 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Pulse rate2 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, Body temperature0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal CriteriaAny increase, SBP3 Participants
Primary

Part 1: Number of Participants With TEAEs Leading to Discontinuation

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Discontinuation1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs Leading to Discontinuation1 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs Leading to Discontinuation0 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs Leading to Discontinuation1 Participants
Primary

Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays4 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays2 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays1 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays2 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays2 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays4 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays2 Participants
Primary

Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.

Time frame: Up to 27 months

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs9 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs6 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs2 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs9 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs5 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs4 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs2 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs6 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs2 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs5 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs5 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs3 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)TEAEs6 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)STEAEs2 Participants
Primary

Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria

Urine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.

Time frame: Up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaPro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriapH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaGlu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaSpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaOB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range CriteriaKetones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,00 Participants
Primary

Part 2: Number of Participants With Any QTcF Interval Increases From Baseline According to Markedly Abnormal Criteria

12-lead ECG was planned to be performed to measure QTcF interval.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range

Blood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance.

Time frame: Baseline (Day 1: Pre-dose) and up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range

Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count.

Time frame: Baseline (Day 1: Pre-dose) and up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With TEAEs and STEAEs

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 27 months

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With TEAEs Leading to Discontinuation

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With Vital Signs Any Decreases From Baseline According to Markedly Abnormal Criteria

Vital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With Vital Signs Any Increases From Baseline According to Markedly Abnormal Criteria

Vital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Primary

Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria

Urine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091

Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1, n=5,5,8,3,148.08 Hours*picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 15, n=2,2,6,3,0256.7 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 15, n=2,2,6,3,0318.3 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1, n=5,5,8,3,1227.6 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 57, n=0,3,2,1,0267.9 Hours*picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1, n=5,5,8,3,11804 Hours*picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 15, n=2,2,6,3,01907 Hours*picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 57, n=0,3,2,1,02027 Hours*picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 15, n=2,2,6,3,03479 Hours*picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1, n=5,5,8,3,13615 Hours*picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 57, n=0,3,2,1,03515 Hours*picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091Day 1, n=5,5,8,3,14166 Hours*picogram per milliliter
Secondary

Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091

Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1, n=7,5,9,4,24.180 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 8, n=8,5,8,3,14.720 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 15, n=9,4,8,3,05.110 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 57, n=4,3,4,1,06.400 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 64, n=5,4,3,2,03.340 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 78, n=5,3,4,2,03.980 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 162, n=1,0,0,0,03.450 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 246, n=1,0,0,0,037.20 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 414, n=1,0,0,0,018.60 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 498, n=1,0,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 15, n=9,4,8,3,05.120 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 78, n=5,3,4,2,010.10 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 8, n=8,5,8,3,16.160 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 64, n=5,4,3,2,07.055 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 57, n=4,3,4,1,07.470 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1, n=7,5,9,4,24.920 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 57, n=4,3,4,1,032.60 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 8, n=8,5,8,3,130.85 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1, n=7,5,9,4,229.20 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 15, n=9,4,8,3,035.63 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 78, n=5,3,4,2,022.70 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 64, n=5,4,3,2,026.70 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 78, n=5,3,4,2,072.22 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 15, n=9,4,8,3,057.57 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 57, n=4,3,4,1,060.09 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1, n=7,5,9,4,259.95 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 64, n=5,4,3,2,075.05 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 8, n=8,5,8,3,171.91 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 8, n=8,5,8,3,189.51 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091Day 1, n=7,5,9,4,282.18 Picogram per milliliter
Secondary

Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 27 months

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK31749985 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK31749980 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK31749982 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK31749981 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK31749980 Participants
Secondary

Part 1a: Plasma Concentration of GSK1795091

Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. Pharmacokinetic (PK) Population consisted of all participants from the All Treated population for whom a PK sample was obtained, analyzed, measurable, and valid.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 24 hours, n=8,5,9,4,20.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=9,3,9,2,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,5,9,4,23.960 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 4 hours, n=8,5,9,4,23.680 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 24 hours, n=6,4,6,2,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 4 hours, n=8,5,7,2,13.190 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=6,3,6,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=5,3,4,2,03.980 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=9,5,8,3,14.300 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 24 hours, n=9,3,8,3,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 246: 10 minutes, n=1,0,0,0,037.200 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=4,4,4,1,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 4 hours, n=4,3,6,1,03.855 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 4 hours, n=9,3,6,3,02.830 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=4,3,4,1,06.400 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=5,4,3,2,03.340 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 2 hours, n=8,5,9,4,21.580 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=9,5,9,4,20.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 162: 10 minutes, n=1,0,0,0,03.450 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 6 hours, n=8,3,9,4,10.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=8,4,8,3,05.255 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 498: 10 minutes, n=1,0,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 414: 10 minutes, n=1,0,0,0,018.600 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=6,3,6,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=4,3,4,1,07.470 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 4 hours, n=4,3,6,1,03.530 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 24 hours, n=6,4,6,2,02.665 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 4 hours, n=8,5,9,4,23.680 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=4,4,4,1,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 6 hours, n=8,3,9,4,13.470 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 24 hours, n=8,5,9,4,22.190 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=5,3,4,2,010.100 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,5,9,4,24.920 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=9,5,8,3,16.160 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 4 hours, n=8,5,7,2,13.790 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=9,5,9,4,20.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=5,4,3,2,07.055 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=9,3,9,2,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=8,4,8,3,05.120 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 4 hours, n=9,3,6,3,04.210 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 2 hours, n=8,5,9,4,24.090 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 24 hours, n=9,3,8,3,03.050 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 4 hours, n=4,3,6,1,013.735 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=9,3,9,2,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=5,3,4,2,022.700 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 6 hours, n=8,3,9,4,125.700 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=6,3,6,0,01.215 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=8,4,8,3,035.625 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 4 hours, n=9,3,6,3,025.675 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 4 hours, n=8,5,9,4,227.300 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=4,4,4,1,03.040 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=9,5,9,4,20.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 24 hours, n=6,4,6,2,016.595 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=9,5,8,3,130.850 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,5,9,4,228.800 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=5,4,3,2,026.700 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=4,3,4,1,032.600 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 4 hours, n=8,5,7,2,116.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 24 hours, n=9,3,8,3,018.970 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 2 hours, n=8,5,9,4,229.200 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 24 hours, n=8,5,9,4,215.800 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=4,4,4,1,015.300 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=9,5,9,4,20.000 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,5,9,4,256.330 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 2 hours, n=8,5,9,4,257.195 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 4 hours, n=8,5,9,4,247.315 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 6 hours, n=8,3,9,4,146.040 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 24 hours, n=8,5,9,4,235.265 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=8,5,8,3,14.590 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=9,5,8,3,171.910 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 4 hours, n=8,5,7,2,161.830 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=9,3,9,2,04.975 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=8,4,8,3,057.570 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 4 hours, n=9,3,6,3,050.950 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 15: 24 hours, n=9,3,8,3,041.770 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=9,3,7,3,04.450 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=4,3,4,1,060.090 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 4 hours, n=4,3,6,1,055.980 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 57: 24 hours, n=6,4,6,2,051.390 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=5,4,3,2,075.045 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=5,3,4,2,072.215 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,5,9,4,282.175 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=8,5,8,3,14.160 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 24 hours, n=8,5,9,4,239.120 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 6 hours, n=8,3,9,4,157.180 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=9,5,9,4,20.000 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 4 hours, n=8,5,9,4,260.945 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 1: 2 hours, n=8,5,9,4,262.285 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 4 hours, n=8,5,7,2,165.030 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=9,5,8,3,189.510 Picogram per milliliter
Secondary

Part 1a: Predose Concentration (Cpre) of GSK1795091

Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.

Time frame: Days 1, 8, 15, 22, 57, 64, 78, 162, 246, 414 and 498: Pre-dose

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 22, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 8, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 64, n=4,4,4,1,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 57, n=4,3,4,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 15, n=9,3,8,2,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 64, n=4,4,4,1,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 22, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 57, n=4,3,4,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 8, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 15, n=9,3,8,2,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 8, n=8,5,8,3,10.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 57, n=4,3,4,0,01.215 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 22, n=9,3,7,3,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 15, n=9,3,8,2,00.000 Picogram per milliliter
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 64, n=4,4,4,1,03.040 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 64, n=4,4,4,1,015.30 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 8, n=8,5,8,3,14.590 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 15, n=9,3,8,2,04.975 Picogram per milliliter
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 22, n=9,3,7,3,04.450 Picogram per milliliter
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1a: Predose Concentration (Cpre) of GSK1795091Day 8, n=8,5,8,3,14.160 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 498, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 414, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 246, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 162, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 78, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1a: Predose Concentration (Cpre) of GSK1795091Day 1, n=0,0,0,0,0 Picogram per milliliter
Secondary

Part 1b: AUC(0-tau) GSK1795091

Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 1, n=4,4,0,0,0819.1 Hours*picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 15, n=3,2,0,0,0661.9 Hours*picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 57, n=1,2,0,0,0845.2 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 1, n=4,4,0,0,01840 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 15, n=3,2,0,0,01453 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: AUC(0-tau) GSK1795091Day 57, n=1,2,0,0,01757 Hours*picogram per milliliter
Secondary

Part 1b: Cmax of GSK1795091

Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 64, n=2,2,0,0,06.910 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 8, n=5,4,0,0,015.28 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 57, n=3,2,0,0,014.62 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 15, n=4,4,0,0,016.00 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 1, n=6,5,0,0,014.95 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 78, n=2,2,0,0,06.980 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 1, n=6,5,0,0,032.30 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 57, n=3,2,0,0,028.16 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 15, n=4,4,0,0,027.80 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 78, n=2,2,0,0,034.88 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 8, n=5,4,0,0,029.55 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cmax of GSK1795091Day 64, n=2,2,0,0,034.35 Picogram per milliliter
Secondary

Part 1b: Cpre of GSK1795091

Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.

Time frame: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 15, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 57, n=3,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 22, n=5,2,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 8, n=5,4,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 64, n=1,2,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 15, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 64, n=1,2,0,0,01.875 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 8, n=5,4,0,0,02.215 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 22, n=5,2,0,0,01.015 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Cpre of GSK1795091Day 57, n=3,1,0,0,02.300 Picogram per milliliter
UnknownPart 1b: Cpre of GSK1795091Day 78, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1b: Cpre of GSK1795091Day 1, n=0,0,0,0,0 Picogram per milliliter
Secondary

Part 1b: Number of Participants With the Present ADA Against GSK3359609

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 27 months

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Number of Participants With the Present ADA Against GSK33596090 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Number of Participants With the Present ADA Against GSK33596091 Participants
Secondary

Part 1b: Plasma Concentration of GSK1795091

Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=6,5,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=6,5,0,0,012.870 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 2 hours, n=6,5,0,0,014.100 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 4 hours, n=6,5,0,0,013.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 6 hours, n=6,4,0,0,012.065 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 24 hours, n=6,4,0,0,07.680 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=5,4,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=5,4,0,0,015.280 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: 4 hours, n=5,4,0,0,011.460 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=4,4,0,0,016.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 4 hours, n=4,4,0,0,010.145 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 24 hours, n=5,2,0,0,06.890 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=5,2,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=3,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=3,2,0,0,014.620 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 4 hours, n=1,1,0,0,012.140 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 24 hours, n=3,2,0,0,08.250 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=1,2,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=2,2,0,0,06.910 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=2,2,0,0,06.980 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=4,4,0,0,027.645 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=6,5,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=1,2,0,0,01.875 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=6,5,0,0,032.300 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 4 hours, n=4,4,0,0,024.100 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 2 hours, n=6,5,0,0,029.770 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 4 hours, n=1,1,0,0,025.510 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 4 hours, n=6,5,0,0,025.330 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: 24 hours, n=5,2,0,0,014.735 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 6 hours, n=6,4,0,0,023.690 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=2,2,0,0,034.875 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 1: 24 hours, n=6,4,0,0,019.650 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=5,2,0,0,01.015 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=5,4,0,0,02.215 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 24 hours, n=3,2,0,0,017.530 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=5,4,0,0,029.550 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=3,1,0,0,02.300 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 8: 4 hours, n=5,4,0,0,023.850 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=2,2,0,0,034.345 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1b: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=3,2,0,0,028.155 Picogram per milliliter
Secondary

Part 1c: AUC(0-tau) GSK1795091

Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 1, n=4,5,0,0,0851.7 Hours*picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 15, n=3,2,0,0,0566.9 Hours*picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 57, n=2,1,0,0,0778.0 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 1, n=4,5,0,0,01611 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 15, n=3,2,0,0,01189 Hours*picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: AUC(0-tau) GSK1795091Day 57, n=2,1,0,0,01640 Hours*picogram per milliliter
Secondary

Part 1c: Cmax of GSK1795091

Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 1, n=6,6,0,0,013.75 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 8, n=6,5,0,0,013.53 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 15, n=6,6,0,0,010.19 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 57, n=2,1,0,0,014.67 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 64, n=3,1,0,0,013.57 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 78, n=2,0,0,0,015.46 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 1, n=6,6,0,0,030.56 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 64, n=3,1,0,0,031.68 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 8, n=6,5,0,0,025.35 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 57, n=2,1,0,0,023.84 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cmax of GSK1795091Day 15, n=6,6,0,0,028.02 Picogram per milliliter
Secondary

Part 1c: Cpre of GSK1795091

Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.

Time frame: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 8, n=5,5,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 22, n=3,3,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 64, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 57, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 15, n=3,4,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 64, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 8, n=5,5,0,0,02.060 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 15, n=3,4,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 22, n=3,3,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Cpre of GSK1795091Day 57, n=2,1,0,0,00.000 Picogram per milliliter
UnknownPart 1c: Cpre of GSK1795091Day 78, n=0,0,0,0,0 Picogram per milliliter
UnknownPart 1c: Cpre of GSK1795091Day 1, n=0,0,0,0,0 Picogram per milliliter
Secondary

Part 1c: Number of Participants With the Present ADA Against Pembrolizumab

Serum samples were collected at indicated time points for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were planned to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 27 months

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Samples were collected but will not be analyzed for the presence of anti-pembrolizumab antibodies as pembrolizumab immunogenicity has been previously characterized.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Number of Participants With the Present ADA Against PembrolizumabNA Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Number of Participants With the Present ADA Against PembrolizumabNA Participants
Secondary

Part 1c: Plasma Concentration of GSK1795091

Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.

Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose

Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

ArmMeasureGroupValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 78: 10 minutes, n=2,0,0,0,015.455 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 2 hours, n=6,6,0,0,011.475 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 4 hours, n=7,6,0,0,09.890 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 6 hours, n=7,6,0,0,09.460 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 24 hours, n=7,6,0,0,08.370 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=6,5,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=7,5,0,0,012.810 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: 4 hours, n=6,5,0,0,09.420 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=3,4,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=7,6,0,0,09.200 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 4 hours, n=7,4,0,0,07.070 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 24 hours, n=7,5,0,0,04.580 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=2,1,0,0,014.665 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: 4 hours, n=2,0,0,0,010.515 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: 24 hours, n=2,2,0,0,07.460 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=3,1,0,0,013.570 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=7,6,0,0,00.000 Picogram per milliliter
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,6,0,0,013.600 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: Pre-dose, n=7,6,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: Pre-dose, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 10 minutes, n=7,6,0,0,027.965 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 10 minutes, n=7,6,0,0,028.015 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 2 hours, n=6,6,0,0,028.775 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: 24 hours, n=2,2,0,0,09.780 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 4 hours, n=7,6,0,0,025.970 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 4 hours, n=7,4,0,0,017.825 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 6 hours, n=7,6,0,0,024.415 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 57: 10 minutes, n=2,1,0,0,023.840 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 1: 24 hours, n=7,6,0,0,015.825 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: 24 hours, n=7,5,0,0,011.230 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: Pre-dose, n=6,5,0,0,02.060 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 64: 10 minutes, n=3,1,0,0,031.680 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: 10 minutes, n=7,5,0,0,024.260 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 22: Pre-dose, n=4,3,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 8: 4 hours, n=6,5,0,0,023.390 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 64: Pre-dose, n=2,1,0,0,00.000 Picogram per milliliter
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1c: Plasma Concentration of GSK1795091Day 15: Pre-dose, n=3,4,0,0,00.000 Picogram per milliliter
Secondary

Part 1: Disease Control Rate

Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (NUMBER)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Disease Control Rate44.4 Percentage of participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Disease Control Rate33.3 Percentage of participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Disease Control Rate33.3 Percentage of participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Disease Control Rate25.0 Percentage of participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Disease Control Rate0.0 Percentage of participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Disease Control Rate16.7 Percentage of participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Disease Control Rate20.0 Percentage of participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Disease Control Rate14.3 Percentage of participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Disease Control Rate33.3 Percentage of participants
Secondary

Part 1: Duration of Response

Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, duration of response could not be calculated as no participants had a confirmed CR or PR with in these arms.

ArmMeasureValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Duration of Response13.73 Months
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Duration of ResponseNA Months
Secondary

Part 1: Objective Response Rate

Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureValue (NUMBER)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Objective Response Rate11.1 Percentage of participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Objective Response Rate0.0 Percentage of participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Objective Response Rate0.0 Percentage of participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Objective Response Rate0.0 Percentage of participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Objective Response Rate0.0 Percentage of participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Objective Response Rate0.0 Percentage of participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Objective Response Rate0.0 Percentage of participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Objective Response Rate0.0 Percentage of participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Objective Response Rate33.3 Percentage of participants
Secondary

Part 1: Overall Survival

Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.

ArmMeasureValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Overall Survival9.03 Months
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Overall Survival7.75 Months
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Overall Survival16.69 Months
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Overall Survival6.72 Months
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Overall Survival11.14 Months
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Overall Survival4.48 Months
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Overall Survival2.89 Months
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Overall Survival3.91 Months
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Overall SurvivalNA Months
Secondary

Part 1: Progression-free Survival

Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. PFS was determined according to RECIST version 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.

ArmMeasureValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Progression-free Survival2.79 Months
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Progression-free Survival3.29 Months
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Progression-free Survival2.60 Months
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Progression-free Survival2.25 Months
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Progression-free SurvivalNA Months
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Progression-free Survival2.28 Months
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Progression-free Survival1.41 Months
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Progression-free Survival2.22 Months
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Progression-free Survival2.37 Months
Secondary

Part 1: Time to Response

Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, time to response could not be calculated as no participants had a confirmed CR or PR with in these arms.

ArmMeasureValue (MEDIAN)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Time to Response5.6 Months
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Time to Response2.0 Months
Secondary

Part 2a: Number of Participants With the Present ADA Against GSK3174998

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2b: Number of Participants With the Present ADA Against GSK3359609

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2c: Number of Participants With the Present ADA Against Pembrolizumab

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Disease Control Rate

Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Duration of Response

Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Objective Response Rate

Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Overall Survival

Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Progression-free Survival

Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest by RECIST v 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Secondary

Part 2: Time to Response

Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Other Pre-specified

Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs9 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs1 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs6 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs2 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs9 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs5 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs4 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs1 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs0 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs2 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs6 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs2 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs5 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs5 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs3 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs and STEAEs Until End of the StudyTEAEs6 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With TEAEs and STEAEs Until End of the StudySTEAEs2 Participants
Other Pre-specified

Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters

Blood samples were collected for the analysis of following chemistry parameters: albumin (Hypo), ALP, ALT, AST, bilirubin, calcium (Hyper and Hypo), creatinine, glucose (Hyper and Hypo), potassium (Hyper and Hypo) and sodium (Hyper and Hypo). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.

Time frame: Up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,05 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,07 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,01 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,04 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersBilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCreatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAlbumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersSodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersPotassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersCalcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersGlucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry ParametersAST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,02 Participants
Other Pre-specified

Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho) (Low), hemoglobin (Hb) (Low) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.

Time frame: Up to 2 years

Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,07 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,06 Participants
Part 1a: 50ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,02 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,01 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,03 Participants
Part 1a: 100ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,04 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,03 Participants
Part 1a: 150ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,02 Participants
Part 1a: 200ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1a: 250ng GSK1795091 + 24mg GSK3174998Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,02 Participants
Part 1b: 50ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,05 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,03 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1b: 100ng GSK1795091 + 80mg GSK3359609Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,00 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,02 Participants
Part 1c: 50ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,00 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersNeutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,02 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersPC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,01 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersHb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,03 Participants
Part 1c: 100ng GSK1795091 + 200mg PembrolizumabPart 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersLympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,03 Participants
Other Pre-specified

Part 2: Number of Participants With TEAEs and STEAEs Until End of the Study

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.

Time frame: Up to 47 months and 13 days

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Other Pre-specified

Part 2: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters

Blood samples were planned to be collected for the analysis of following chemistry parameters: albumin, ALP, ALT, AST, bilirubin, calcium, creatinine, glucose, potassium and sodium.

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Other Pre-specified

Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), hemoglobin (Hb) and platelet count (PC).

Time frame: Up to 2 years

Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026