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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04128696
Registration number
NCT04128696
Ethics application status
Date submitted
15/10/2019
Date registered
16/10/2019
Date last updated
7/02/2024
Titles & IDs
Public title
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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Scientific title
A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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Secondary ID [1]
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2019-002263-99
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Secondary ID [2]
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209229
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Universal Trial Number (UTN)
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Trial acronym
INDUCE-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
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0
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0
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Kidney
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Cancer
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0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - feladilimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo
Experimental: Participants receiving feladilimab and pembrolizumab - Participants were administered feladilimab (humanized anti-ICOS immunoglobulin G4 [IgG4] monoclonal antibody [mAb]) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an intravenous (IV) infusion once every three weeks.
Active Comparator: Participants receiving placebo and pembrolizumab - Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion once every three weeks.
Treatment: Drugs: feladilimab
feladilimab is available as an intravenous infusion.
Treatment: Drugs: Pembrolizumab
Pembrolizumab is available as an intravenous infusion.
Treatment: Drugs: Placebo
Placebo is available as an intravenous infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) =1 Population
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Assessment method [1]
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OS was defined as the time from the date of randomization to the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [1]
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Up to approximately 16 months
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Primary outcome [2]
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OS in the PD-L1 Expression High (CPS =20) Population
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Assessment method [2]
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OS was defined as the time from the date of randomization to the date of death due to any cause. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [2]
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Up to approximately 16 months
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Primary outcome [3]
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS =1 Population
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Assessment method [3]
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PFS per RECIST version (v)1.1 was defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [3]
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Up to approximately 16 months
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Secondary outcome [1]
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PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS =1 Population
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Assessment method [1]
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PFS per iRECIST was defined as the interval of time from the date of randomization to the date of the first documented disease progression confirmed consecutively per iRECIST based on investigator assessment, or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [1]
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Up to approximately 16 months
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Secondary outcome [2]
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PFS Per RECIST in the PD-L1 CPS =20 Population
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Assessment method [2]
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PFS per RECIST v1.1 was defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [2]
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Up to approximately 16 months
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Secondary outcome [3]
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PFS Per iRECIST (iPFS) in the PD-L1 CPS =20 Population
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Assessment method [3]
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PFS per iRECIST was defined as the interval of time from the date of randomization to the date of the first documented disease progression confirmed consecutively per iRECIST based on investigator assessment, or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [3]
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Up to approximately 16 months
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Secondary outcome [4]
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Milestone OS Rate at 12 Months in the PD-L1 CPS =1 Population
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Assessment method [4]
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Milestone OS rate at 12 months was estimated using the Kaplan-Meier method. Associated 95% confidence intervals are estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Milestone OS Rate at 24 Months in the PD-L1 CPS =1 Population
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Assessment method [5]
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Milestone OS rate at 24 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Milestone OS Rate at 12 Months in the PD-L1 CPS =20 Population
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Assessment method [6]
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Milestone OS rate at 12 months was estimated using the Kaplan-Meier method. Associated 95% confidence intervals are estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Milestone OS Rate at 24 Months in the PD-L1 CPS =20 Population
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Assessment method [7]
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Milestone OS rate at 24 months was not evaluated. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
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Assessment method [8]
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ORR per RECIST v1.1 was defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [8]
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Up to approximately 16 months
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Secondary outcome [9]
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ORR Per RECIST v1.1 in the PD-L1 CPS =20 Population
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Assessment method [9]
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ORR per RECIST v1.1 was defined as the proportion of the participants who have a CR or PR as the best overall response per RECIST v1.1 based upon investigator assessment. As a randomized double-blind study in which primary endpoints are OS and PFS, the confirmation of CR and PR was not required. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [9]
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Up to approximately 16 months
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Secondary outcome [10]
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Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
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Assessment method [10]
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DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD=15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [10]
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Up to approximately 16 months
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Secondary outcome [11]
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DCR Per RECIST v1.1 in the PD-L1 CPS =20 Population
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Assessment method [11]
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DCR per RECIST v1.1 based upon investigator assessment, was defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 15 weeks. A status of SD=15 weeks will be assigned if the follow-up disease assessment has met the SD criteria at least once after the date of randomization at a minimum of 14 weeks (98 days) considering a one-week visit window. Rate and associated 2-sided 95 percent Exact (Clopper-Pearson) Confidence Intervals are provided for each treatment arm which are unadjusted. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [11]
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Up to approximately 16 months
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Secondary outcome [12]
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Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
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Assessment method [12]
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DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [12]
0
0
Up to approximately 16 months
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Secondary outcome [13]
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DoR Per RECIST v1.1 in the PD-L1 CPS =20 Population
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Assessment method [13]
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DoR per RECIST v1.1 is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. Kaplan-Meier estimate for the median DoR is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [13]
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Up to approximately 16 months
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Secondary outcome [14]
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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [14]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement.
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Timepoint [14]
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Up to approximately 16 months
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Secondary outcome [15]
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Number of Participants With AEs by Severity
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Assessment method [15]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of each AE was reported during the study and was assigned a grade according to the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE). AEs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE.
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Timepoint [15]
0
0
Up to approximately 16 months
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Secondary outcome [16]
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Number of Participants With SAEs by Severity
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Assessment method [16]
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An SAE was 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, any other situation such as important medical events according to medical or scientific judgement. Severity of each SAE was reported during the study and was assigned a grade according to the NCI-CTCAE. SAEs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing SAEs of Grade =3 have been presented.
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Timepoint [16]
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Up to approximately 16 months
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Secondary outcome [17]
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Number of Participants With Adverse Events of Special Interest (AESI)
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Assessment method [17]
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AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated.
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Timepoint [17]
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Up to approximately 16 months
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Secondary outcome [18]
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Number of Participants With AESI by Severity
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Assessment method [18]
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AESI were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Such events recently reported after treatment with other immune modulatory therapy include colitis, uveitis, hepatitis, pneumonitis, diarrhea, endocrine disorders, and specific cutaneous toxicities, as well as other events that may be immune mediated. Severity of each AESI was reported during the study and was assigned a grade according to the NCI-CTCAE. AESIs severity were graded on a 5-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, 3 = severe; inability to work or perform normal daily activity, 4 = life-threatening consequences and 5 = death related to AE. Data of participants experiencing AESIs of Grade =3 have been presented.
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Timepoint [18]
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Up to approximately 16 months
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Secondary outcome [19]
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Number of Participants With Dose Modifications
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Assessment method [19]
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Number of participants with dose modifications (including dose interruptions, dose delays and treatment discontinuations) were reported by each interventional component.
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Timepoint [19]
0
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Up to approximately 16 months
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Secondary outcome [20]
0
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Time to Deterioration (TTD) in Pain in the PD-L1 CPS =1 Population
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Assessment method [20]
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TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the European Organization for Research and Treatment of Cancer Item Library(EORTC IL51) pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC Quality of Life Questionnaire 35-Item Head and Neck Module (QLQ-H&N35) is a head and neck specific module with multi-item scales. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [20]
0
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Up to approximately 16 months
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Secondary outcome [21]
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TTD in Pain in the PD-L1 CPS =20 Population
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Assessment method [21]
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TTD in pain is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the EORTC IL51 pain domain, i.e. an increase from baseline of at least 8.33 observed at all subsequent non-missing visits. The EORTC QLQ-H&N35 is a head and neck specific module with multi-item scales. The mouth pain, swallowing, speech problems, opening mouth, coughing, feeding tube, and trouble with social eating domains were administered and referred to as the EORTC IL51. The questionnaire scores for each scale and single-item measure are averaged and transformed linearly to present a score ranging from 0-100. A high score represents a high/healthy level of functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [21]
0
0
Up to approximately 16 months
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Secondary outcome [22]
0
0
TTD in Physical Function in the PD-L1 CPS =1 Population
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Assessment method [22]
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TTD in physical function is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c. The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [22]
0
0
Up to approximately 16 months
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Secondary outcome [23]
0
0
TTD in Physical Function in the PD-L1 CPS =20 Population
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Assessment method [23]
0
0
TTD in physical function is defined as the time from randomization to the first definitive meaningful deterioration from baseline in the PF T-score, i.e. a decrease from baseline of at least 2.4 observed at all subsequent non-missing visits, as measured by the PROMIS PF 8c. The PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It includes a 5-point scale with three sets of response options. Scores on the PROMIS PF 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. Data are presented for the PD-L1 CPS >=1 participants from mITT population. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells.
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Timepoint [23]
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Up to approximately 16 months
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Eligibility
Key inclusion criteria
- Capable of giving signed informed consent
- Male or female, age >=18 years
- Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma
(HNSCC) that is considered incurable by local therapies
- Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx
- No prior systemic therapy administered in the recurrent or metastatic setting (except
for systemic therapy given as part of multimodal treatment for locally advanced
disease)
- Measurable disease per RECIST version 1.1 guidelines
- ECOG Performance PS score of 0 or 1
- Adequate organ function
- Life expectancy of at least 12 weeks
- Female participants: must not be pregnant, not breastfeeding, and at least one of the
following conditions apply:
1. Not a woman of childbearing potential (WOCBP)
2. A WOCBP who agrees to use a method of birth control from 30 days prior to
randomization and for at least 120 days after the last dose of study treatment
- Male participants with female partners of child-bearing potential: must agree to use a
highly effective contraception while receiving study treatment and for at least 120
days after the last dose of study treatment and refrain from donating sperm during
this period
- Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone
biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1
immunohistochemistry (IHC) testing by central laboratory
- Have PD-L1 Immunohistochemistry (IHC) CPS 1 status by central laboratory testing
- Have results from testing of Human Papilloma Virus (HPV) status for oropharyngeal
cancer
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
- Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives
of the drug, whichever is shorter
- Major surgery 28 days prior to randomization
- Has high risk of bleeding
- Toxicity related to prior treatment that has not resolved to <=Grade 1 (except
alopecia, hearing loss, endocrinopathy managed with replacement therapy, and
peripheral neuropathy which must be<= Grade 2)
- Received transfusion of blood products or administration of colony stimulating factors
within 14 days prior to randomization
- Central nervous system (CNS) metastases, with the following exception: Participants
with asymptomatic CNS metastases who are clinically stable and have no requirement for
steroids for at least 14 days prior to randomization
- Invasive malignancy or history of invasive malignancy other than disease under study
within the last 3 years, except as noted below:
a. Any other invasive malignancy for which the participant was definitively treated,
has been disease-free for 3 years and in the opinion of the principal investigator and
GSK Medical Monitor will not affect the evaluation of the effects of the study
treatment on the currently targeted malignancy, may be included in this clinical study
- Autoimmune disease or syndrome that required systemic treatment within the past 2
years
- Has a diagnosis of immunodeficiency or is receiving systemic steroids (=10 mg oral
prednisone per day or equivalent) or other immunosuppressive agents within 7 days
prior to randomization
- Receipt of any live vaccine within 30 days prior randomization
- Prior allogeneic/autologous bone marrow or solid organ transplantation
- Has current pneumonitis or history of non-infectious pneumonitis that required
steroids or other immunosuppressive agents
- Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural
or pericardial effusions
- Recent history (within the past 6 months) of gastrointestinal obstruction that
required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal
abscess
- Recent history of allergen desensitization therapy within 4 weeks of randomization
- History or evidence of cardiac abnormalities within the 6 months prior to
randomization
- Cirrhosis or current unstable liver or biliary disease per investigator assessment
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,
esophageal or gastric varices, or persistent jaundice
- Active infection requiring systemic therapy
- Known HIV infection, or positive test for hepatitis B active infection (presence of
hepatitis B surface antigen), or hepatitis C active infection
- History of severe hypersensitivity to monoclonal antibodies or any ingredient used in
the study treatment formulations
- Known history of active tuberculosis
- Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric
disorder, or other condition that could interfere with participant's safety, obtaining
informed consent, or compliance to the study procedures in the opinion of the
investigator
- Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from
last dose of prior investigational agent), or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks prior to
date of randomization
- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/06/2023
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Sample size
Target
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Accrual to date
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Final
315
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
0
0
GSK Investigational Site - Blacktown
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Recruitment hospital [2]
0
0
GSK Investigational Site - St Leonards
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Recruitment hospital [3]
0
0
GSK Investigational Site - Herston
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Recruitment hospital [4]
0
0
GSK Investigational Site - Heidelberg
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Recruitment hospital [5]
0
0
GSK Investigational Site - Melbourne
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Recruitment hospital [6]
0
0
GSK Investigational Site - Nedlands
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Recruitment hospital [7]
0
0
GSK Investigational Site - Darlinghurst
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Recruitment postcode(s) [1]
0
0
2148 - Blacktown
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Recruitment postcode(s) [2]
0
0
2065 - St Leonards
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Recruitment postcode(s) [3]
0
0
4029 - Herston
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Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [5]
0
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3000 - Melbourne
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6009 - Nedlands
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2010 - Darlinghurst
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Porto
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Russian Federation
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Russian Federation
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Pushkin
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Zuerich
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Changhua
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Taiwan
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Taoyuan City
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United Kingdom
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Lancashire
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Ethics approval
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Summary
Brief summary
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as
first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or
metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized,
double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T
cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo
in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score
(CPS) >=1 R/M HNSCC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04128696
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04128696
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