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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/NCT04428333
Registration number
NCT04428333
Ethics application status
Date submitted
9/06/2020
Date registered
11/06/2020
Date last updated
15/02/2024
Titles & IDs
Public title
Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With 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 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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Secondary ID [1]
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2019-003981-42
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Secondary ID [2]
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209227
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Universal Trial Number (UTN)
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Trial acronym
INDUCE-4
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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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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
Treatment: Drugs - Platinum based chemotherapy
Treatment: Drugs - Fluorouracil (5FU)
Experimental: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapy -
Placebo Comparator: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy -
Treatment: Drugs: Feladilimab
Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Treatment: Drugs: Pembrolizumab
Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb
Treatment: Drugs: Placebo
Sterile normal saline
Treatment: Drugs: Platinum based chemotherapy
Cisplatin/carboplatin
Treatment: Drugs: Fluorouracil (5FU)
5-fluorouracil
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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 mITT 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. 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 7 months
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Primary outcome [2]
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OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) =1 Population
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Assessment method [2]
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OS was defined as the time from the date of randomization until 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 7 months
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Primary outcome [3]
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Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population
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Assessment method [3]
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PFS per Response Evaluation Criteria in Solid Tumors (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. 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 7 months
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Secondary outcome [1]
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PFS Per RECIST v1.1 in the PD-L1 CPS =1 Population
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Assessment method [1]
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PFS per RECIST v1.1 was defined as the time from the date of randomization until the date of 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 [1]
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Up to approximately 7 months
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Secondary outcome [2]
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Milestone OS Rate at 12, 24 and 36 Months in mITT Population
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Assessment method [2]
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Milestone OS rate at 12, 24, and 36 months was not evaluated.
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Timepoint [2]
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Months 12, 24 and 36
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Secondary outcome [3]
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Milestone OS Rate at 12, 24 and 36 Months in PD-L1 CPS =1 Population
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Assessment method [3]
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Milestone OS rate at 12, 24, and 36 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 [3]
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Months 12, 24 and 36
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Secondary outcome [4]
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Overall Response Rate (ORR) Per RECIST v1.1 in mITT Population
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Assessment method [4]
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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.
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Timepoint [4]
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0
Up to approximately 7 months
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Secondary outcome [5]
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ORR Per RECIST v1.1 in PD-L1 CPS =1 Population
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Assessment method [5]
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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 [5]
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0
Up to approximately 7 months
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Secondary outcome [6]
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Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population
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Assessment method [6]
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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.
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Timepoint [6]
0
0
Up to approximately 7 months
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Secondary outcome [7]
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DCR Per RECIST v1.1 in PD-L1 CPS =1 Population
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Assessment method [7]
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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 [7]
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0
Up to approximately 7 months
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Secondary outcome [8]
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Duration of Response (DoR) Per RECIST v1.1 in mITT Population
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Assessment method [8]
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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.
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Timepoint [8]
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0
Up to approximately 7 months
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Secondary outcome [9]
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DoR Per RECIST v1.1 in PD-L1 CPS =1 Population
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Assessment method [9]
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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 [9]
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Up to approximately 7 months
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Secondary outcome [10]
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Number of Participants With Adverse Events (AEs) in Safety Population
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Assessment method [10]
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An AE is 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
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Timepoint [10]
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Up to approximately 7 months
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Secondary outcome [11]
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Number of Participants With Serious Adverse Events (SAEs) in Safety Population
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Assessment method [11]
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SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement.
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Timepoint [11]
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Up to approximately 7 months
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Secondary outcome [12]
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Number of Participants With Adverse Events of Special Interest (AESI) in Safety Population
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Assessment method [12]
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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 [12]
0
0
Up to approximately 7 months
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Secondary outcome [13]
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Number of Participants With AEs in PD-L1 CPS =1 Population
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Assessment method [13]
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Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. 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]
0
0
Up to approximately 7 months
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Secondary outcome [14]
0
0
Number of Participants With SAEs in PD-L1 CPS =1 Population
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Assessment method [14]
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0
SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other situations according to medical or scientific judgement. 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 [14]
0
0
Up to approximately 7 months
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Secondary outcome [15]
0
0
Number of Participants With AESIs in PD-L1 CPS =1 Population
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Assessment method [15]
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0
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. 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 [15]
0
0
Up to approximately 7 months
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Secondary outcome [16]
0
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Severity of AEs in Safety Population
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Assessment method [16]
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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 for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity.
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Timepoint [16]
0
0
Up to approximately 7 months
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Secondary outcome [17]
0
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Severity of SAEs in Safety Population
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Assessment method [17]
0
0
A 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 for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade >= 3 have been presented.
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Timepoint [17]
0
0
Up to approximately 7 months
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Secondary outcome [18]
0
0
Severity of AESIs in Safety Population
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Assessment method [18]
0
0
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]
0
0
Up to approximately 7 months
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Secondary outcome [19]
0
0
Severity of AEs in PD-L1 CPS =1 Population
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Assessment method [19]
0
0
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 for each AE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing AEs of Grade >= 3 have been presented. 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 [19]
0
0
Up to approximately 7 months
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Secondary outcome [20]
0
0
Severity of SAEs in PD-L1 CPS =1 Population
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Assessment method [20]
0
0
A 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 for each SAE was reported during the study and assigned a grade according to the NCI-CTCAE v5.0. from Grade 1 through Grade 5. Grade 1= mild toxicity; Grade 2 = moderate toxicity; Grade 3 = severe toxicity; Grade 4 = life-threatening or disabling toxicity, Grade 5 = death related to toxicity. Data of participants experiencing SAEs of Grade >= 3 have been presented. 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
0
Up to approximately 7 months
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Secondary outcome [21]
0
0
Severity of AESI in PD-L1 CPS =1 Population
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Assessment method [21]
0
0
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 [21]
0
0
Up to approximately 7 months
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Secondary outcome [22]
0
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Number of Participants With Dose Modifications in Safety Population
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Assessment method [22]
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0
Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component.
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Timepoint [22]
0
0
Up to approximately 7 months
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Secondary outcome [23]
0
0
Number of Participants With Dose Modifications in PD-L1 CPS =1 Population
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Assessment method [23]
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0
Number of participants with dose modifications (including dose interruptions, dose delays, dose reductions and treatment discontinuations) were reported by each interventional component. 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]
0
0
Up to approximately 7 months
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Secondary outcome [24]
0
0
Time to Deterioration (TTD) in Pain in mITT Population
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Assessment method [24]
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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) Questionnaire 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 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. Kaplan-Meier estimate for the median TTD is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
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Timepoint [24]
0
0
Up to approximately 7 months
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Secondary outcome [25]
0
0
TTD in Pain in PD-L1 CPS =1 Population
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Assessment method [25]
0
0
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. Kaplan-Meier estimate for the median TTD 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 to the total number of viable tumor cells.
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Timepoint [25]
0
0
Up to approximately 7 months
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Secondary outcome [26]
0
0
TTD in Physical Function in mITT Population
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Assessment method [26]
0
0
TTD in physical function (PF) 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 Patient-Reported Outcomes Measurement Information System - Physical Function (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.
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Timepoint [26]
0
0
Up to approximately 7 months
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Secondary outcome [27]
0
0
TTD in Physical Function in PD-L1 CPS =1 Population
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Assessment method [27]
0
0
TTD in PF 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 [27]
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Up to approximately 7 months
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Eligibility
Key inclusion criteria
- Capable of giving signed informed consent
- Male or female, age >=18 years
- HNSCC that was diagnosed as recurrent or metastatic and 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 (with
the exception of systemic therapy completed >6 months prior if given as part of
multimodal treatment for locally advanced disease and no disease
progression/recurrence within 6 months of the completion of curatively intended
systemic treatment).
- Measurable disease per RECIST version 1.1 guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status (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 be either not a
woman of childbearing potential (WOCBP); or be a WOCBP who agrees to use a highly
effective 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 periods.
- 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 IHC CPS 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, anti-Inducible T Cell Co-Stimulatory Receptor
(ICOS) directed agent.
- Systemic approved or investigational anticancer therapy within 30 days or 5 half lives
of the drug, whichever is shorter. At least 14 days must have elapsed between the last
dose of prior anticancer agent and the date of randomization. - Has high risk of
bleeding (examples include but not limited to tumors encasing or infiltrating a major
vessel [i.e. carotid, jugular, bronchial artery] and/or exhibits other high-risk
features such as an arteriovenous fistula)
- Active tumor bleeding - Grade 3 or Grade 4 hypercalcemia.
- Major surgery less than or equal to (<=) 28 days prior to randomization.
- Participants must have also fully recovered from any surgery (major or minor) and/or
its complications before randomization
- Toxicity from previous anticancer treatment that includes: a. Grade 3/Grade 4 toxicity
considered related to prior immunotherapy and that led to treatment discontinuation
and b. 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 with the exception of: a. any other invasive malignancy for
which the participant was definitively treated, has been disease-free for <=3 years.
b. curatively treated non-melanoma skin cancer or successfully treated in situ
carcinoma and/or. c. low-risk early stage prostate cancer defined as: Stage T1c or T2a
with a Gleason score <=6 and prostatic-specific antigen less than (<)10 nanograms per
milliliter (ng/mL) either treated with definitive intent or untreated in active
surveillance that has been stable for the past year prior to randomization.
- Autoimmune disease or syndrome that required systemic treatment within the past 2
years.
- Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 milligram
[mg] oral prednisone 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 which include: a. Serious, uncontrolled cardiac arrhythmia or clinically
significant electrocardiogram 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. c. Congestive heart failure (Class II, III, or IV) as defined by
the New York Heart Association functional classification system. d. Symptomatic
pericarditis.
- 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.
- Active infection requiring systemic therapy.
- Known human immunodeficiency virus (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 to the chemotherapies
under investigation including any ingredient used in the formulation.
- Known history of active tuberculosis.
- Any serious (>=Grade 3) and/or unstable pre-existing medical condition (aside from
malignancy).
- Any 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 or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the date of
randomization.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
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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Query!
Query!
Query!
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
Query!
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
13/08/2020
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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
19/09/2023
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Sample size
Target
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Accrual to date
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Final
118
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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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 - Woolloongabba
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Recruitment hospital [3]
0
0
GSK Investigational Site - Heidelberg
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Recruitment hospital [4]
0
0
GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
0
0
2148 - Blacktown
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Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [3]
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0
3084 - Heidelberg
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Recruitment postcode(s) [4]
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0
3000 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Entre Ríos
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Country [3]
0
0
Argentina
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State/province [3]
0
0
Santa Fe
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Tucumán
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Country [5]
0
0
Argentina
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State/province [5]
0
0
Ciudad Autonoma de Buenos Aires
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Ciudad Autónoma de Buenos Aires
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Bruxelles
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Edegem
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Country [9]
0
0
Brazil
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State/province [9]
0
0
Espírito Santo
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Country [10]
0
0
Brazil
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State/province [10]
0
0
Paraná
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Country [11]
0
0
Brazil
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State/province [11]
0
0
São Paulo
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Country [12]
0
0
Canada
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State/province [12]
0
0
Alberta
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Country [13]
0
0
Canada
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State/province [13]
0
0
Ontario
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Country [14]
0
0
Canada
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State/province [14]
0
0
Quebec
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Country [15]
0
0
Denmark
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State/province [15]
0
0
Koebenhavn Oe
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Country [16]
0
0
France
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State/province [16]
0
0
Bordeaux
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Country [17]
0
0
France
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State/province [17]
0
0
Lyon cedex 08
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Country [18]
0
0
France
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State/province [18]
0
0
Paris
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Country [19]
0
0
France
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State/province [19]
0
0
Poitiers cedex
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Country [20]
0
0
France
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State/province [20]
0
0
Strasbourg
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Country [21]
0
0
Germany
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State/province [21]
0
0
Baden-Wuerttemberg
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Country [22]
0
0
Germany
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State/province [22]
0
0
Niedersachsen
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Country [23]
0
0
Germany
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State/province [23]
0
0
Sachsen
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Country [24]
0
0
Germany
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State/province [24]
0
0
Berlin
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Country [25]
0
0
Hungary
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State/province [25]
0
0
Nyíregyháza
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Country [26]
0
0
Ireland
Query!
State/province [26]
0
0
Dublin
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Country [27]
0
0
Italy
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State/province [27]
0
0
Campania
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Country [28]
0
0
Italy
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State/province [28]
0
0
Lazio
Query!
Country [29]
0
0
Italy
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State/province [29]
0
0
Liguria
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Country [30]
0
0
Italy
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State/province [30]
0
0
Lombardia
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Country [31]
0
0
Italy
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State/province [31]
0
0
Toscana
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Country [32]
0
0
Japan
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State/province [32]
0
0
Osaka
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Country [33]
0
0
Japan
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State/province [33]
0
0
Tokyo
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Country [34]
0
0
Korea, Republic of
Query!
State/province [34]
0
0
Daegu-si
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Country [35]
0
0
Korea, Republic of
Query!
State/province [35]
0
0
Gyeonggi-do
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Country [36]
0
0
Korea, Republic of
Query!
State/province [36]
0
0
Hwasun-gun, Jeollanam-do
Query!
Country [37]
0
0
Korea, Republic of
Query!
State/province [37]
0
0
Seoul
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Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Bydgoszcz
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Gdynia
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Gliwice
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Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Lublin
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Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Tomaszow Mazowiecki
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Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Warszawa
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Country [44]
0
0
Romania
Query!
State/province [44]
0
0
Bucuresti
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Country [45]
0
0
Romania
Query!
State/province [45]
0
0
Cluj Napoca
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Country [46]
0
0
Romania
Query!
State/province [46]
0
0
Craiova
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Country [47]
0
0
Romania
Query!
State/province [47]
0
0
Floresti
Query!
Country [48]
0
0
Romania
Query!
State/province [48]
0
0
Otopeni
Query!
Country [49]
0
0
Romania
Query!
State/province [49]
0
0
Suceava
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Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Pushkin
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Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Barcelona
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Country [52]
0
0
Spain
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State/province [52]
0
0
Madrid
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Country [53]
0
0
Spain
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State/province [53]
0
0
Valencia
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Country [54]
0
0
Sweden
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State/province [54]
0
0
Stockholm
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Country [55]
0
0
United Kingdom
Query!
State/province [55]
0
0
London
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Country [56]
0
0
United Kingdom
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State/province [56]
0
0
Nottingham
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Country [57]
0
0
United Kingdom
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State/province [57]
0
0
Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
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Address
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Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Merck Sharp & Dohme LLC
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in
combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab
combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic
(R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase
II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum
chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in
participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx
or larynx.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04428333
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04428333
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