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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002263-99 | EudraCT Number |
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The trial was stopped by the sponsor based on assessment of the clinical data
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving feladilimab and pembrolizumab | Experimental | 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. |
|
| Participants receiving placebo and pembrolizumab | Active Comparator | Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion once every three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feladilimab | Drug | feladilimab is available as an intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population | 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. | Up to approximately 16 months |
| OS in the PD-L1 Expression High (CPS ≥20) Population | 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. | Up to approximately 16 months |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS ≥1 Population | PFS per iRECIST was defined as the interval of time from the date of randomization to the date of the first documented disease progression confirmed consecutively per iRECIST based on investigator assessment, or death due to any cause, whichever occurs first. CPS was defined as the ratio of the combined number of PD-L1 expressing tumor cells and immune cells (lymphocytes and macrophages) to the total number of viable tumor cells. Kaplan-Meier estimate for the median PFS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method. |
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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:
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
Exclusion Criteria:
Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter
Major surgery 28 days prior to randomization
Has high risk of bleeding
Toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be<= Grade 2)
Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization
Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization
Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:
a. Any other invasive malignancy for which the participant was definitively treated, has been disease-free for 3 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical study
Autoimmune disease or syndrome that required systemic treatment within the past 2 years
Has a diagnosis of immunodeficiency or is receiving systemic steroids (≥10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization
Receipt of any live vaccine within 30 days prior randomization
Prior allogeneic/autologous bone marrow or solid organ transplantation
Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
Recent history of allergen desensitization therapy within 4 weeks of randomization
History or evidence of cardiac abnormalities within the 6 months prior to randomization
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
Active infection requiring systemic therapy
Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection
History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations
Known history of active tuberculosis
Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator
Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from last dose of prior investigational agent), or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to date of randomization
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Duarte | California | 91010 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access 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.
Recruitment in the study was stopped following review of interim safety and efficacy data by the Independent Data Monitoring Committee, after a pre-specified futility analysis. A Dear Investigator Letter (DIL) was issued to stop screening/randomization of further subjects to the study.
A total of 315 participants with recurrent or metastatic head and neck squamous cell carcinoma/cancer (HNSCC) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Feladilimab and Pembrolizumab | Participants were administered feladilimab (GSK3359609-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 (Q3W). |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2021 | Apr 26, 2022 |
This will be a randomized, parallel group treatment study with eligible participants receiving GSK3359609 plus pembrolizumab or placebo plus pembrolizumab.
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This will be a double blind study.
| Pembrolizumab | Drug | Pembrolizumab is available as an intravenous infusion. |
|
| Placebo | Drug | Placebo is available as an intravenous infusion. |
|
| Up to approximately 16 months |
| PFS Per RECIST in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| PFS Per iRECIST (iPFS) in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| Milestone OS Rate at 12 Months in the PD-L1 CPS ≥1 Population | 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. | 12 months |
| Milestone OS Rate at 24 Months in the PD-L1 CPS ≥1 Population | 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. | 24 months |
| Milestone OS Rate at 12 Months in the PD-L1 CPS ≥20 Population | 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. | 12 months |
| Milestone OS Rate at 24 Months in the PD-L1 CPS ≥20 Population | 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. | 24 months |
| Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| ORR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| DCR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| DoR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to approximately 43 months |
| Number of Participants With AEs by Severity | 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. | Up to approximately 43 months |
| Number of Participants With SAEs by Severity | 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. | Up to approximately 43 months |
| Number of Participants With Adverse Events of Special Interest (AESI) | 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. | Up to approximately 43 months |
| Number of Participants With AESI by Severity | 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. | Up to approximately 43 months |
| Number of Participants With Dose Modifications | Number of participants with dose modifications (including dose interruptions, dose delays and treatment discontinuations) were reported by each interventional component. | Up to approximately 16 months |
| Time to Deterioration (TTD) in Pain in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| TTD in Pain in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| TTD in Physical Function in the PD-L1 CPS ≥1 Population | 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. | Up to approximately 16 months |
| TTD in Physical Function in the PD-L1 CPS ≥20 Population | 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. | Up to approximately 16 months |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| GSK Investigational Site | St. Petersburg | Florida | 33705 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
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| GSK Investigational Site | Meldola (FC) | Emilia-Romagna | 47014 | Italy |
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| GSK Investigational Site | Bydgoszcz | 85-796 | Poland |
| GSK Investigational Site | Gdynia | 81-519 | Poland |
| GSK Investigational Site | Gliwice | 44-101 | Poland |
| GSK Investigational Site | Krakow | 31-826 | Poland |
| GSK Investigational Site | Olsztyn | 10-228 | Poland |
| GSK Investigational Site | Tomaszów Mazowiecki | 97-200 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Coimbra | 3000-075 | Portugal |
| GSK Investigational Site | Lisbon | 1649-035 | Portugal |
| GSK Investigational Site | Matosinhos Municipality | 4454-509 | Portugal |
| GSK Investigational Site | Porto | 4200-072 | Portugal |
| GSK Investigational Site | Porto | 4200-319 | Portugal |
| GSK Investigational Site | Brasov | 500283 | Romania |
| GSK Investigational Site | Bucharest | 021389 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400015 | Romania |
| GSK Investigational Site | Constanța | 900591 | Romania |
| GSK Investigational Site | Craiova | 200347 | Romania |
| GSK Investigational Site | Floreşti | 407280 | Romania |
| GSK Investigational Site | Iași | 700106 | Romania |
| GSK Investigational Site | Oradea | 410469 | Romania |
| GSK Investigational Site | Otopeni | 075100 | Romania |
| GSK Investigational Site | Satu Mare | 440055 | Romania |
| GSK Investigational Site | Suceava | 720284 | Romania |
| GSK Investigational Site | Moscow | 111123 | Russia |
| GSK Investigational Site | Poselok Kuzmolovsky | 188663 | Russia |
| GSK Investigational Site | Pushkin | 196603 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Saint Petersburg | 198255 | Russia |
| GSK Investigational Site | Yaroslavl | 150054 | Russia |
| GSK Investigational Site | Busan | 49241 | South Korea |
| GSK Investigational Site | Hwasun,Jeollanam-do | 58128 | South Korea |
| GSK Investigational Site | Incheon | 21565 | South Korea |
| GSK Investigational Site | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| GSK Investigational Site | Seoul | 02841 | South Korea |
| GSK Investigational Site | Seoul | 03080 | South Korea |
| GSK Investigational Site | Seoul | 05505 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08908 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28223 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Valencia | 46009 | Spain |
| GSK Investigational Site | Zaragoza | 50009 | Spain |
| GSK Investigational Site | Sankt Gallen | 9007 | Switzerland |
| GSK Investigational Site | Zurich | 8091 | Switzerland |
| GSK Investigational Site | Changhua | 50006 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 833 | Taiwan |
| GSK Investigational Site | Taipei | 10002 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Taipei | 11490 | Taiwan |
| GSK Investigational Site | Taoyuan City | 333 | Taiwan |
| GSK Investigational Site | Manchester | Lancashire | M20 4BX | United Kingdom |
| GSK Investigational Site | London | SW3 6JJ | United Kingdom |
| GSK Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| GSK Investigational Site | Sutton | SM2 5PT | United Kingdom |
| Participants Receiving Placebo and Pembrolizumab |
Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W. |
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| Modified Intent to Treat (mITT) Population | 2 participants (1 from each arm) were dosed after the date of DIL requesting immediate discontinuation of feladilimab/placebo and were not included in the mITT population. |
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| Safety Population | Two participants were initially randomized to placebo+pembrolizumab arm but were dosed with feladilimab. Therefore, they were included in the in the feladilimab+pembrolizumab arm of the safety population. The 2 participants enrolled but excluded from the mITT population (one from each arm) were both included in the placebo+pembrolizumab arm for the safety population, as both participants were only dosed with pembrolizumab. |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Feladilimab and Pembrolizumab | Participants were administered feladilimab (GSK3359609-humanized anti-ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W. |
| BG001 | Participants Receiving Placebo and Pembrolizumab | Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population | 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. | mITT: All randomized participants, whether or not randomized intervention was administered, excluding those who were first dosed or randomized after the date of DIL requesting immediate discontinuation of feladilimab /placebo. This analysis was based on the study intervention to which the participant was randomized. All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Primary | OS in the PD-L1 Expression High (CPS ≥20) Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Secondary | PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Secondary | PFS Per RECIST in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Secondary | PFS Per iRECIST (iPFS) in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Median | 95% Confidence Interval | Week | Up to approximately 16 months |
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| Secondary | Milestone OS Rate at 12 Months in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
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| Secondary | Milestone OS Rate at 24 Months in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were to be analyzed. Data for this endpoint were not collected as all participants were on the study for < 24 months, the maximum duration of follow-up was approximately 16 months. | Posted | 24 months |
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| Secondary | Milestone OS Rate at 12 Months in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
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| Secondary | Milestone OS Rate at 24 Months in the PD-L1 CPS ≥20 Population | 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. | Participants with PD-L1 CPS ≥20 in the mITT population were to be analyzed. Data for this endpoint were not collected as all participants were on the study for <24 months, the maximum duration of follow-up was approximately 16 months. | Posted | 24 months |
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| Secondary | Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 16 months |
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| Secondary | ORR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 16 months |
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| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 16 months |
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| Secondary | DCR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 16 months |
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| Secondary | Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population | 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. | Data for participants with a best overall response of CR or PR in the mITT population with PD-L1 CPS ≥1 are presented. | Posted | Median | 95% Confidence Interval | Weeks | Up to approximately 16 months |
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| Secondary | DoR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population | 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. | Data for participants with a best overall response of CR or PR in the mITT population with PD-L1 CPS ≥20 are presented. | Posted | Median | 95% Confidence Interval | Weeks | Up to approximately 16 months |
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| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population: All randomized participants who take at least 1 dose of study intervention. Participants were assigned to the actual study intervention group of feladilimab + pembrolizumab if the participant received any dose of feladilimab. Participants were analyzed according to the actual study intervention received. | Posted | Count of Participants | Participants | Up to approximately 43 months |
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| Secondary | Number of Participants With AEs by Severity | 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. | Safety Population: All randomized participants who take at least 1 dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 43 months |
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| Secondary | Number of Participants With SAEs by Severity | 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. | Safety Population: All randomized participants who take at least 1 dose of study intervention | Posted | Count of Participants | Participants | Up to approximately 43 months |
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| Secondary | Number of Participants With Adverse Events of Special Interest (AESI) | 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. | All participants in the safety population were analyzed | Posted | Count of Participants | Participants | Up to approximately 43 months |
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| Secondary | Number of Participants With AESI by Severity | 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. | All participants in the safety population were analyzed | Posted | Count of Participants | Participants | Up to approximately 43 months |
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| Secondary | Number of Participants With Dose Modifications | Number of participants with dose modifications (including dose interruptions, dose delays and treatment discontinuations) were reported by each interventional component. | All participants in the safety population were analyzed | Posted | Count of Participants | Participants | Up to approximately 16 months |
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| Secondary | Time to Deterioration (TTD) in Pain in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 16 months |
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| Secondary | TTD in Pain in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 16 months |
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| Secondary | TTD in Physical Function in the PD-L1 CPS ≥1 Population | 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. | All participants with PD-L1 CPS ≥1 in the mITT population were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 16 months |
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| Secondary | TTD in Physical Function in the PD-L1 CPS ≥20 Population | 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. | Data for participants with PD-L1 CPS ≥20 in mITT population are presented. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 16 months |
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All cause mortality, non-SAEs and SAEs were collected from Day 1 to up to approximately 43 months.
2 participants were initially randomized to placebo+pembrolizumab arm but were dosed with feladilimab. Therefore, they were included in feladilimab+pembrolizumab arm of the safety population. The 2 participants enrolled but excluded from the mITT population (1 from each arm) were both included in placebo+pembrolizumab arm for the safety population, as both were only dosed with pembrolizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Receiving Feladilimab and Pembrolizumab | Participants were administered feladilimab (GSK3359609-humanized anti-ICOS IgG4 mAb) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W. | 116 | 159 | 52 | 159 | 125 | 159 |
| EG001 | Participants Receiving Placebo and Pembrolizumab | Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion Q3W. | 97 | 156 | 53 | 156 | 128 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fistula discharge | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2021 | Apr 26, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| ≥85 years |
|
| Male |
|
| Asian - East Asian Heritage |
|
| Asian - Japanese Heritage |
|
| Black or African American |
|
| Missing |
|
| Mixed White Race |
|
| Multiple |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Native Hawaiian or Other Pacific Islander |
|
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