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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447314
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: GSK1795091 Drug: GSK3174998 Drug: GSK3359609 Drug: Pembrolizumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study of GSK1795091 Administered in Combination With Immunotherapies in Participants With Advanced Solid Tumors
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 25, 2022

Arm Intervention/treatment
Experimental: Part 1a: GSK3174998 24 mg
In Part 1, subjects with advanced solid tumors will be enrolled. Part 1a will have up to five dose escalation cohorts to investigate the safety and tolerability of escalating doses of GSK1795091 in combination with GSK3174998 24 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

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

Experimental: Part 1b: GSK3359609 80 mg
In Part 1, subjects with advanced solid tumors will be enrolled. Part 1b will have up to five dose escalation cohorts to investigate the safety and tolerability of escalating doses of GSK1795091 in combination with GSK3359609 80 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

Drug: GSK3359609
GSK3359609 will be available as solution for infusion.

Experimental: Part 1c: pembrolizumab 200 mg
In Part 1, subjects with advanced solid tumors will be enrolled. Part 1c will have up to five dose escalation cohorts to investigate the safety and tolerability of escalating doses of GSK1795091 in combination with pembrolizumab 200 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

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

Experimental: Part 1: PK/Pharmacodynamic cohort
Subjects will be enrolled into PK/PD cohort to collect additional data on safety, PK, and pharmacodynamic endpoints. Subjects will be enrolled at previously completed dose levels following dose escalation.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

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

Drug: GSK3359609
GSK3359609 will be available as solution for infusion.

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

Experimental: Part 2a: GSK3174998 24 mg
In Part 2, subjects with recurrent, locally advanced or metastatic SCCHN will be included. Subjects will be administered GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

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

Experimental: Part 2b: GSK3359609 80 mg
In Part 2, subjects with recurrent, locally advanced or metastatic SCCHN will be included. Subjects will be administered GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

Drug: GSK3359609
GSK3359609 will be available as solution for infusion.

Experimental: Part 2c: pembrolizumab 200 mg
In Part 2, subjects with recurrent, locally advanced or metastatic SCCHN will be included. Subjects will be administered GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg.
Drug: GSK1795091
GSK1795091 will be available as solution for injection

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




Primary Outcome Measures :
  1. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
    AEs will be assessed at each visit from first dose until the treatment discontinuation visit (TDV) and until 90 days after last dose for adverse events of special interest (AESI) and SAEs.

  2. Number of subjects with dose-limiting toxicities (DLTs) [ Time Frame: Up to 2 years ]
    An AE is considered to be a DLT if it is considered by the investigator to be clinically relevant and is attributed to the study treatment and meets at least 1 of the pre-specified criteria.

  3. Number of subjects withdrawn due to AEs [ Time Frame: Up to 2 years ]
    The number of subjects withdrawn due to AEs throughout the study will be summarized.

  4. Number of subjects with dose reductions or delays [ Time Frame: Up to 2 years ]
    The number of subjects with dose reductions or delays will be summarized.

  5. Number of subjects with abnormal hematology parameters [ Time Frame: Up to 2 years ]
    The following hematology parameters will be evaluated: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  6. Number of subjects with abnormal clinical chemistry parameters [ Time Frame: Up to 2 years ]
    The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose, calculated creatinine clearance (CrCl), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, C-reactive protein, total and direct bilirubin, total protein and albumin.

  7. Number of subjects with abnormal urine parameters [ Time Frame: Up to 2 years ]
    The following parameters will be evaluated in urine: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Microscopic examination will be performed if blood or protein is abnormal.

  8. Number of subjects with abnormal temperature [ Time Frame: Up to 2 years ]
    Temperature will be measured in semi-supine position after 5 minutes of rest.

  9. Number of subjects with abnormal blood pressure [ Time Frame: Up to 2 years ]
    Systolic and diastolic blood pressure will be measured in semi-supine position after 5 minutes of rest.

  10. Number of subjects with abnormal pulse rate [ Time Frame: Up to 2 years ]
    Pulse rate will be measured in semi-supine position after 5 minutes of rest.

  11. Number of subjects with abnormal electrocardiogram (ECG) measurement [ Time Frame: Up to 2 years ]
    Twelve-lead ECGs will be obtained using an ECG machine after at least 10 minutes of rest.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 2 years ]
    Objective response rate is defined as percentage of subjects with complete response (CR) or partial response (PR). Objective response rate will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  2. Disease control rate [ Time Frame: Up to 2 years ]
    Disease control rate is defined as percentage of subjects with CR or PR or at least 12 weeks of stable disease. Disease control rate will be evaluated according to RECIST 1.1.

  3. Time to response [ Time Frame: Up to 2 years ]
    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).

  4. Duration of response [ Time Frame: Up to 2 years ]
    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 subjects who achieve an overall response (that is, unconfirmed or confirmed CR or PR)

  5. Number of subjects with progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    PFS is defined as time from 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.

  6. Number of subjects with overall survival [ Time Frame: Up to 2 years ]
    Overall survival is defined as time from the date of first dose to the date of death due to any cause.

  7. Plasma concentration of GSK1795091-Part 1 [ Time Frame: Day15 (pre-dose,10minutes,4hours post-dose),Day16 (24hours post-dose),Day22 (pre-dose),Day57 (pre-dose,10minutes,4hours post-dose),Day58 (24hours post-dose), Day64 (pre-dose,10minutes post-dose),10minutes post-dose on Day78 and every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for the determination of plasma concentration of GSK1795091. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion.

  8. Plasma concentration of GSK1795091-Part 2 [ Time Frame: Day1 (pre-dose, 10minutes, 2, 4, 6hours post-dose), Day8 (pre-dose), Day22 (10minutes post-dose), Day43 (pre-dose, 10minutes, 4 hours post-dose), Day50 (pre-dose, 10minutes post-dose), 10minutes post-dose on Day64, Day85 and then every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for the determination of plasma concentration of GSK1795091. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion. For Days 8 and 50, pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK1795091 injection.

  9. Maximum plasma concentration (Cmax) of GSK1795091-Part 1 [ Time Frame: Day15 (pre-dose,10minutes,4hours post-dose),Day16 (24hours post-dose),Day22 (pre-dose),Day57 (pre-dose,10minutes,4hours post-dose),Day58 (24hours post dose), Day64 (pre-dose,10minutes post-dose),10minutes post-dose on Day78 and every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of Cmax. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion.

  10. Cmax of GSK1795091-Part 2 [ Time Frame: Day1 (pre-dose, 10minutes, 2, 4, 6hours post-dose), Day8 (pre-dose), Day22 (10minutes post-dose), Day43 (pre-dose, 10minutes, 4 hours post-dose), Day50 (pre-dose, 10minutes post-dose), 10minutes post-dose on Day64, Day85 and then every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of Cmax. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion. For Days 8 and 50, pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK1795091 injection.

  11. Area under the concentration-time curve over the dosing interval (AUC [0-tau]) GSK1795091-Part 1 [ Time Frame: Day15 (pre-dose,10minutes,4hours post-dose),Day16 (24hours post-dose),Day22 (pre-dose),Day57 (pre-dose,10minutes,4hours post-dose),Day58 (24hours post-dose), Day64 (pre-dose,10minutes post-dose),10minutes post-dose on Day78 and every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of AUC (0-tau). Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion.

  12. AUC (0-tau) of GSK1795091-Part 2 [ Time Frame: Day1 (pre-dose, 10minutes, 2, 4, 6hours post-dose), Day8 (pre-dose), Day22 (10minutes post-dose), Day43 (pre-dose, 10minutes, 4 hours post-dose), Day50 (pre-dose, 10minutes post-dose), 10minutes post-dose on Day64, Day85 and then every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of AUC (0-tau). Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion. For Days 8 and 50, pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK1795091 injection.

  13. Trough plasma concentrations (Ctrough) of GSK1795091-Part 1 [ Time Frame: Day15 (pre-dose,10minutes,4hours post-dose),Day16 (24hours post-dose),Day22 (pre-dose),Day57 (pre-dose,10minutes,4hours post-dose),Day58 (24hours post-dose), Day64 (pre-dose,10minutes post-dose),10minutes post-dose on Day78 and every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of Ctrough. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion.

  14. Ctrough of GSK1795091-Part 2 [ Time Frame: Day1 (pre-dose, 10minutes, 2, 4, 6hours post-dose), Day8 (pre-dose), Day22 (10minutes post-dose), Day43 (pre-dose, 10minutes, 4 hours post-dose), Day50 (pre-dose, 10minutes post-dose), 10minutes post-dose on Day64, Day85 and then every 12weeks for 2years ]
    Blood samples will be collected at indicated time points for determination of Ctrough. Pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK3174998, GSK3359609, or pembrolizumab infusion. For Days 8 and 50, pre-dose indicates the blood sample will be collected within 60 minutes before the start of the GSK1795091 injection.

  15. Number of subjects who develop detectable antidrug antibody (ADA) against GSK3174998 [ Time Frame: Up to 2 years ]
    Serum samples will be collected and tested for the presence of antibodies that bind to GSK3174998.

  16. Number of subjects who develop ADA against GSK3359609 [ Time Frame: Up to 2 years ]
    Serum samples will be collected and tested for the presence of antibodies that bind to GSK3359609.

  17. Number of subjects who develop ADA against pembrolizumab [ Time Frame: Up to 2 years ]
    Serum samples will be collected and tested for the presence of antibodies that bind to pembrolizumab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447314


Locations
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United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63110
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1Z6
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Sevilla, Spain, 41009
Sponsors and Collaborators
GlaxoSmithKline
Iqvia Pty Ltd
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03447314    
Other Study ID Numbers: 204686
2017-003545-23 ( EudraCT Number )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
pembrolizumab
GSK1795091
Dose-escalation
204686
Immunotherapies
GSK3359609
Phase I
anticancer agent
OX40
201212
204691
ICOS
TLR4
GSK3174998
Advanced Solid Tumors
Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents