Study of a Combination of GSK1795091 and Immunotherapies... | NCT03447314

NCT03447314

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2017-003545-23	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
IQVIA Pty Ltd	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1a: 50ng GSK1795091 + 24mg GSK3174998	Experimental	Participants will be administered GSK1795091 50 nanogram (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 will be administered in combination with GSK3174998 24 mg at Q3W interval.	Drug: GSK1795091 Drug: GSK3174998
Part 1a: 100ng GSK1795091 + 24mg GSK3174998	Experimental	Participants will be 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 will be administered in combination with GSK3174998 24 mg at Q3W interval.	Drug: GSK1795091 Drug: GSK3174998
Part 1a: 150ng GSK1795091 + 24mg GSK3174998	Experimental	Participants will be 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 will be administered in combination with GSK3174998 24 mg at Q3W interval.	Drug: GSK1795091 Drug: GSK3174998
Part 1a: 200ng GSK1795091 + 24mg GSK3174998	Experimental	Participants will be 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 will be administered in combination with GSK3174998 24 mg at Q3W interval.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK1795091	Drug	GSK1795091 will be available as solution for injection	Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Part 1a: 150ng GSK1795091 + 24mg GSK3174998

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 27 months
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.	Up to 27 months
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.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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 Exclusion Criteria for Subjects in Part 2c

Received prior anti-PD-1/PD-L1 therapy.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Boston	Massachusetts	02215	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36097345	Derived	Steeghs N, Hansen AR, Hanna GJ, Garralda E, Park H, Strauss J, Adam M, Campbell G, Carver J, Easton R, Mays K, Skrdla P, Struemper H, Washburn ML, Matheny C, Piha-Paul SA. Manufacturing-dependent change in biological activity of the TLR4 agonist GSK1795091 and implications for lipid A analog development. Clin Transl Sci. 2022 Nov;15(11):2625-2639. doi: 10.1111/cts.13387. Epub 2022 Sep 12.

IPD Sharing Statement Module

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.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.
FG002	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.
FG003	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.
FG004	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.
FG005	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.
FG006	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.
FG007	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.
FG008	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.
FG009	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.
FG010	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.
FG011	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.
FG012	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.
FG013	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.
FG014	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.
FG015	Part 2a: GSK1795091 + 24 mg GSK3174998	Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
FG016	Part 2b: GSK1795091 + 80 mg GSK3359609	Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
FG017	Part 2c: GSK1795091 + 200 mg Pembrolizumab	Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.

Periods

Title

Milestones

Reasons Not Completed

Part 1 (Up to 47 Months and 13 Days)

Type	Comment	Milestone Data
STARTED		FG0009 subjects FG0016 subjects FG0029 subjects FG0034 subjects FG004
COMPLETED		FG0002 subjects FG0011 subjects FG0022 subjects FG0030 subjects FG004
NOT COMPLETED		FG0007 subjects FG0015 subjects FG0027 subjects FG0034 subjects FG004

Type	Comment	Reasons
Death		FG0006 subjects FG0015 subjects FG0024 subjects FG003

Part 2 (Up to 47 Months and 13 Days)

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

Count of Participants

Participants

Up to 27 months

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343		GSKClinicalSupportHD@gsk.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 8, 2020	May 31, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 23, 2020	Jun 1, 2021	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D009369	Neoplasms

Intervention Browse Module

ID	Term
C000712933	TLR4 agonist GSK1795091
C582435	pembrolizumab

Masking Info

Part 1a: 200ng GSK1795091 + 24mg GSK3174998

Part 1a: 250ng GSK1795091 + 24mg GSK3174998

Part 1a: 50ng GSK1795091 + 24mg GSK3174998

Part 1b: 100ng GSK1795091 + 80mg GSK3359609

Part 1b: 150ng GSK1795091 + 80mg GSK3359609

Part 1b: 200ng GSK1795091 + 80mg GSK3359609

Part 1b: 250ng GSK1795091 + 80mg GSK3359609

Part 1b: 50ng GSK1795091 + 80mg GSK3359609

Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab

Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab

Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab

Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab

Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab

Part 2a: GSK1795091 + 24 mg GSK3174998

Part 2b: GSK1795091 + 80 mg GSK3359609

Part 2c: GSK1795091 + 200 mg Pembrolizumab

EG0000 events0 affected9 at risk

EG0010 events0 affected6 at risk

EG0021 events1 affected9 at risk

EG0030 events0 affected4 at risk

EG0040 events0 affected2 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected7 at risk

EG0080 events0 affected6 at risk

EG0004 events3 affected9 at risk

EG0015 events2 affected6 at risk

EG0022 events2 affected9 at risk

EG0031 events1 affected4 at risk

EG0040 events0 affected2 at risk

EG0053 events3 affected6 at risk

EG0062 events2 affected5 at risk

EG0071 events1 affected7 at risk

EG0081 events1 affected6 at risk

OG004NA(NA to NA)Progression-free Survival could not be calculated as no participants had an event in Part 1a: 250ng GSK1795091 + 24mg GSK3174998 arm.

OG0052.28(1.91 to 2.79)

OG0061.41(1.15 to 2.46)

OG0102.22(1.91 to 2.43)

OG0112.37(2.33 to 19.22)

The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.

OG0036.72(3.20 to 9.86)

OG00411.14(11.14 to 11.14)

OG0054.48(3.15 to 8.38)

OG0062.89(2.37 to NA)The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.

OG0103.91(2.66 to NA)The final event experienced by participants within the treatment arm occurred in the first 75% of survival times. Hence, third-quartile could not be derived.

OG011NA(6.08 to NA)The final event experienced by participants within the treatment arm occurred in the first 50% of survival times. Hence, median and third-quartile could not be derived.

OG00482.175(64.97 to 99.38)

OG00462.285(57.57 to 67.00)

OG00460.945(56.43 to 65.46)

OG00457.180(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.

OG00439.120(32.73 to 45.51)

OG0044.160(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.

OG00489.510(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.

OG00465.030(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.

Full range is not applicable due to single participant, and the median value presented here is the actual plasma concentration for this single participant.

OG00489.51(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.

Full range is not applicable due to single participant, and the median value presented here is the actual Cmax for this single participant.

OG0044.160(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.

Full range is not applicable due to single participant, and the median value presented here is the actual Cpre for this single participant.

OG000	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.
OG001	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.
OG002	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.
OG003	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.
OG004	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.
OG005	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.
OG006	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.
OG007	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.
OG008	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.
OG009	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.
OG010	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.
OG011	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.
OG012	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.
OG013	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.
OG014	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.