Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04128696
Registration number
NCT04128696
Ethics application status
Date submitted
15/10/2019
Date registered
16/10/2019
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
Query!
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
Query!
Secondary ID [1]
0
0
2019-002263-99
Query!
Secondary ID [2]
0
0
209229
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
INDUCE-3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Head and neck
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) =1 Population
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to approximately 16 months
Query!
Primary outcome [2]
0
0
OS in the PD-L1 Expression High (CPS =20) Population
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately 16 months
Query!
Primary outcome [3]
0
0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS =1 Population
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to approximately 16 months
Query!
Secondary outcome [1]
0
0
PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS =1 Population
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to approximately 16 months
Query!
Secondary outcome [2]
0
0
PFS Per RECIST in the PD-L1 CPS =20 Population
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately 16 months
Query!
Secondary outcome [3]
0
0
PFS Per iRECIST (iPFS) in the PD-L1 CPS =20 Population
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to approximately 16 months
Query!
Secondary outcome [4]
0
0
Milestone OS Rate at 12 Months in the PD-L1 CPS =1 Population
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
12 months
Query!
Secondary outcome [5]
0
0
Milestone OS Rate at 24 Months in the PD-L1 CPS =1 Population
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
24 months
Query!
Secondary outcome [6]
0
0
Milestone OS Rate at 12 Months in the PD-L1 CPS =20 Population
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
12 months
Query!
Secondary outcome [7]
0
0
Milestone OS Rate at 24 Months in the PD-L1 CPS =20 Population
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
24 months
Query!
Secondary outcome [8]
0
0
Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Up to approximately 16 months
Query!
Secondary outcome [9]
0
0
ORR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Up to approximately 16 months
Query!
Secondary outcome [10]
0
0
Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Up to approximately 16 months
Query!
Secondary outcome [11]
0
0
DCR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Up to approximately 16 months
Query!
Secondary outcome [12]
0
0
Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Up to approximately 16 months
Query!
Secondary outcome [13]
0
0
DoR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Up to approximately 16 months
Query!
Secondary outcome [14]
0
0
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [14]
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. 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.
Query!
Timepoint [14]
0
0
Up to approximately 43 months
Query!
Secondary outcome [15]
0
0
Number of Participants With AEs by Severity
Query!
Assessment method [15]
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 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.
Query!
Timepoint [15]
0
0
Up to approximately 43 months
Query!
Secondary outcome [16]
0
0
Number of Participants With SAEs by Severity
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Up to approximately 43 months
Query!
Secondary outcome [17]
0
0
Number of Participants With Adverse Events of Special Interest (AESI)
Query!
Assessment method [17]
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.
Query!
Timepoint [17]
0
0
Up to approximately 43 months
Query!
Secondary outcome [18]
0
0
Number of Participants With AESI by Severity
Query!
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.
Query!
Timepoint [18]
0
0
Up to approximately 43 months
Query!
Secondary outcome [19]
0
0
Number of Participants With Dose Modifications
Query!
Assessment method [19]
0
0
Number of participants with dose modifications (including dose interruptions, dose delays and treatment discontinuations) were reported by each interventional component.
Query!
Timepoint [19]
0
0
Up to approximately 16 months
Query!
Secondary outcome [20]
0
0
Time to Deterioration (TTD) in Pain in the PD-L1 CPS =1 Population
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Up to approximately 16 months
Query!
Secondary outcome [21]
0
0
TTD in Pain in the PD-L1 CPS =20 Population
Query!
Assessment method [21]
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. 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.
Query!
Timepoint [21]
0
0
Up to approximately 16 months
Query!
Secondary outcome [22]
0
0
TTD in Physical Function in the PD-L1 CPS =1 Population
Query!
Assessment method [22]
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. 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.
Query!
Timepoint [22]
0
0
Up to approximately 16 months
Query!
Secondary outcome [23]
0
0
TTD in Physical Function in the PD-L1 CPS =20 Population
Query!
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.
Query!
Timepoint [23]
0
0
Up to approximately 16 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/11/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/06/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
315
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Blacktown
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - St Leonards
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Darlinghurst
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [7]
0
0
2010 - Darlinghurst
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
South Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Buenos Aires
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
San Juan
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Espírito Santo
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Santa Catarina
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
São Paulo
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Belo Horizonte, Minas Gerais
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
British Columbia
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Guangdong
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Guangxi
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Guizhou
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Hubei
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Jiangxi
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Sichuan
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Bengbu
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Harbin
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Hefei
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shnghai
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Copenhagen
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Bordeaux
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Epagny Metz-Tessy
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Le Mans
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Lille
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lyon cedex 08
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Paris
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Saint Herblain cedex
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Strasbourg
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Toulouse Cedex 9
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Valenciennes Cedex
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Baden-Wuerttemberg
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Nordrhein-Westfalen
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Sachsen
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Berlin
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Hamburg
Query!
Country [48]
0
0
Greece
Query!
State/province [48]
0
0
Heraklion,Crete
Query!
Country [49]
0
0
Greece
Query!
State/province [49]
0
0
Thessaloniki
Query!
Country [50]
0
0
Ireland
Query!
State/province [50]
0
0
Dublin
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Jerusalem
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Petah Tikva
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Ramat Gan
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Emilia-Romagna
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Lombardia
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Piemonte
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Veneto
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Chiba
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Ehime
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Fukuoka
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Hokkaido
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Hyogo
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Ibaraki
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Iwate
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Kagawa
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Kanagawa
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Miyagi
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Niigata
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Osaka
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Saitama
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Shizuoka
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Tokyo
Query!
Country [73]
0
0
Korea, Republic of
Query!
State/province [73]
0
0
Busan
Query!
Country [74]
0
0
Korea, Republic of
Query!
State/province [74]
0
0
Hwasun,Jeollanam-do
Query!
Country [75]
0
0
Korea, Republic of
Query!
State/province [75]
0
0
Incheon
Query!
Country [76]
0
0
Korea, Republic of
Query!
State/province [76]
0
0
Seongnam-si, Gyeonggi-do
Query!
Country [77]
0
0
Korea, Republic of
Query!
State/province [77]
0
0
Seoul,
Query!
Country [78]
0
0
Korea, Republic of
Query!
State/province [78]
0
0
Seoul
Query!
Country [79]
0
0
Mexico
Query!
State/province [79]
0
0
Coahuila
Query!
Country [80]
0
0
Mexico
Query!
State/province [80]
0
0
Jalisco
Query!
Country [81]
0
0
Netherlands
Query!
State/province [81]
0
0
Maastricht
Query!
Country [82]
0
0
Netherlands
Query!
State/province [82]
0
0
Rotterdam
Query!
Country [83]
0
0
Norway
Query!
State/province [83]
0
0
Bergen
Query!
Country [84]
0
0
Norway
Query!
State/province [84]
0
0
Oslo
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Bydgoszcz
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Gdynia
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Gliwice
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Krakow
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Olsztyn
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Tomaszow Mazowiecki
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Warszawa
Query!
Country [92]
0
0
Portugal
Query!
State/province [92]
0
0
Coimbra
Query!
Country [93]
0
0
Portugal
Query!
State/province [93]
0
0
Lisboa
Query!
Country [94]
0
0
Portugal
Query!
State/province [94]
0
0
Matosinhos
Query!
Country [95]
0
0
Portugal
Query!
State/province [95]
0
0
Porto
Query!
Country [96]
0
0
Romania
Query!
State/province [96]
0
0
Brasov
Query!
Country [97]
0
0
Romania
Query!
State/province [97]
0
0
Bucuresti
Query!
Country [98]
0
0
Romania
Query!
State/province [98]
0
0
Cluj Napoca
Query!
Country [99]
0
0
Romania
Query!
State/province [99]
0
0
Cluj-Napoca
Query!
Country [100]
0
0
Romania
Query!
State/province [100]
0
0
Constanta
Query!
Country [101]
0
0
Romania
Query!
State/province [101]
0
0
Craiova
Query!
Country [102]
0
0
Romania
Query!
State/province [102]
0
0
Floresti
Query!
Country [103]
0
0
Romania
Query!
State/province [103]
0
0
Iasi
Query!
Country [104]
0
0
Romania
Query!
State/province [104]
0
0
Oradea
Query!
Country [105]
0
0
Romania
Query!
State/province [105]
0
0
Otopeni
Query!
Country [106]
0
0
Romania
Query!
State/province [106]
0
0
Satu Mare
Query!
Country [107]
0
0
Romania
Query!
State/province [107]
0
0
Suceava
Query!
Country [108]
0
0
Russian Federation
Query!
State/province [108]
0
0
Moscow
Query!
Country [109]
0
0
Russian Federation
Query!
State/province [109]
0
0
Poselok Kuzmolovsky
Query!
Country [110]
0
0
Russian Federation
Query!
State/province [110]
0
0
Pushkin
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Saint-Petersburg
Query!
Country [112]
0
0
Russian Federation
Query!
State/province [112]
0
0
St. Petersburg
Query!
Country [113]
0
0
Russian Federation
Query!
State/province [113]
0
0
Yaroslavl
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Barcelona
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Madrid
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Málaga
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Pozuelo De Alarcón/Madrid
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Santiago de Compostela
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Valencia
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Zaragoza
Query!
Country [121]
0
0
Switzerland
Query!
State/province [121]
0
0
St Gallen
Query!
Country [122]
0
0
Switzerland
Query!
State/province [122]
0
0
Zuerich
Query!
Country [123]
0
0
Taiwan
Query!
State/province [123]
0
0
Changhua
Query!
Country [124]
0
0
Taiwan
Query!
State/province [124]
0
0
Kaohsiung City
Query!
Country [125]
0
0
Taiwan
Query!
State/province [125]
0
0
Taipei
Query!
Country [126]
0
0
Taiwan
Query!
State/province [126]
0
0
Taoyuan City
Query!
Country [127]
0
0
United Kingdom
Query!
State/province [127]
0
0
Lancashire
Query!
Country [128]
0
0
United Kingdom
Query!
State/province [128]
0
0
London
Query!
Country [129]
0
0
United Kingdom
Query!
State/province [129]
0
0
Nottingham
Query!
Country [130]
0
0
United Kingdom
Query!
State/province [130]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Merck Sharp & Dohme LLC
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04128696
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Query!
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a data sharing agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/96/NCT04128696/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT04128696/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04128696