Clinical Trials List
Protocol Number209227
NCT Number(ClinicalTrials.gov Identfier)NCT04428333
2020-12-01 - 2021-06-29
Phase II/III
Recruiting1
Terminated6
ICD-9V10.21
Personal history of malignant neoplasm of larynx
A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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Sponsor
GlaxoSmithKline
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳宇欽 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 蔡文銓 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 賴學緯 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 戴明燊 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HUAI-CHENG HUANG Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- YA-FANG CHEN Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- Sheng-Yu Chen Division of Hematology & Oncology
- Ling-Wei Wang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tung-Chieh Chang Division of Radiation Therapy
- Chi-Ting Liau Division of Hematology & Oncology
- Tzu-Chen Yen Division of Nuclear Medicine
- 廖俊達 Division of Hematology & Oncology
- Pei-Wei Huang Division of Hematology & Oncology
- Li-Yu Lee Division of Others -
- Chia-Hsun Hsieh Division of Hematology & Oncology
- Shu-Hang Ag Division of Radiology
- Cheng-Lung Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Objectives
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx. Approximately 640 participants will be enrolled in the study.
Test Drug
GSK3359609
Active Ingredient
GSK3359609
Dosage Form
IV injection
Dosage
10 mg/ml
Endpoints
Overall Survival (OS) in total population [ Time Frame: Up to 66 months ]
OS in the total population, defined as the time from the date of randomization until the date of death due to any cause.
OS in programmed death receptor-ligand 1 (PD-L1) combined positive score (CPS) >=1 population [ Time Frame: Up to 66 months ]
OS in the PD-L1 CPS >=1 population, defined as the time from the date of randomization until the date of death due to any cause
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in total population [ Time Frame: Up to 48 months ]
PFS per RECIST v1.1 in the total population, defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first.
OS in the total population, defined as the time from the date of randomization until the date of death due to any cause.
OS in programmed death receptor-ligand 1 (PD-L1) combined positive score (CPS) >=1 population [ Time Frame: Up to 66 months ]
OS in the PD-L1 CPS >=1 population, defined as the time from the date of randomization until the date of death due to any cause
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in total population [ Time Frame: Up to 48 months ]
PFS per RECIST v1.1 in the total population, defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first.
Inclution Criteria
Inclusion Criteria:
Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies.
Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease and no disease progression/recurrence within 6 months of the completion of curatively intended systemic treatment).
Measurable disease.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
Adequate organ function.
Life expectancy of at least 12 weeks.
Female participants: must not be pregnant, not breastfeeding, and be either not a woman of childbearing potential (WOCBP); or be a WOCBP who agrees to use a highly effective method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment.
Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this periods.
Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory.
Have PD-L1 IHC CPS status by central laboratory testing.
Have results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies.
Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease and no disease progression/recurrence within 6 months of the completion of curatively intended systemic treatment).
Measurable disease.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
Adequate organ function.
Life expectancy of at least 12 weeks.
Female participants: must not be pregnant, not breastfeeding, and be either not a woman of childbearing potential (WOCBP); or be a WOCBP who agrees to use a highly effective method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment.
Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this periods.
Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory.
Have PD-L1 IHC CPS status by central laboratory testing.
Have results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
Exclusion Criteria
Exclusion Criteria:
Prior therapy with an anti-PD-1/L1/L2, anti-Inducible T Cell Co-Stimulatory Receptor (ICOS ) directed agent.
Systemic approved or investigational anticancer therapy within 30 days or 5 half lives of the drug, whichever is shorter.
Has high risk of bleeding.
Active tumor bleeding
Grade 3 or Grade 4 hypercalcemia.
Major surgery <=28 days prior to randomization.
Toxicity from previous anticancer treatment that includes: a. Grade 3/Grade 4 toxicity related to prior immunotherapy and that led to treatment discontinuation and toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <=Grade 2).
Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization.
Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization.
Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years with the exception of any other invasive malignancy for which the participant was definitively treated, has been disease-free for <=3 years, curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma and/or low-risk early stage prostate cancer.
Autoimmune disease or syndrome that required systemic treatment within the past 2 years.
Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 milligram (mg) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to randomization.
Receipt of any live vaccine within 30 days prior randomization.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents.
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions .
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
Recent history of allergen desensitization therapy within 4 weeks of randomization.
History or evidence of cardiac abnormalities within the 6 months prior to randomization which include.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Active infection requiring systemic therapy.
Known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.
History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation.
Known history of active tuberculosis.
Any serious and/or unstable pre-existing medical condition (aside from malignancy).
Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the date of randomization.
Prior therapy with an anti-PD-1/L1/L2, anti-Inducible T Cell Co-Stimulatory Receptor (ICOS ) directed agent.
Systemic approved or investigational anticancer therapy within 30 days or 5 half lives of the drug, whichever is shorter.
Has high risk of bleeding.
Active tumor bleeding
Grade 3 or Grade 4 hypercalcemia.
Major surgery <=28 days prior to randomization.
Toxicity from previous anticancer treatment that includes: a. Grade 3/Grade 4 toxicity related to prior immunotherapy and that led to treatment discontinuation and toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <=Grade 2).
Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization.
Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization.
Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years with the exception of any other invasive malignancy for which the participant was definitively treated, has been disease-free for <=3 years, curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma and/or low-risk early stage prostate cancer.
Autoimmune disease or syndrome that required systemic treatment within the past 2 years.
Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 milligram (mg) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to randomization.
Receipt of any live vaccine within 30 days prior randomization.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents.
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions .
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
Recent history of allergen desensitization therapy within 4 weeks of randomization.
History or evidence of cardiac abnormalities within the 6 months prior to randomization which include.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Active infection requiring systemic therapy.
Known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.
History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation.
Known history of active tuberculosis.
Any serious and/or unstable pre-existing medical condition (aside from malignancy).
Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the date of randomization.
The Estimated Number of Participants
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Taiwan
8 participants
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Global
640 participants
