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 - INDUCE-4

Ishibashi Hideyasu0 个研究点目标入组 640 人开始时间: 2020年12月3日最近更新: 2024年5月27日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 640

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•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.

排除标准

•- 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

研究者

发起方

Ishibashi Hideyasu

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