| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Is your age greater than or equal to 18 yrs? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have any of these conditions: Do you have head and neck cancer?? |
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| Do you have head and neck cancer? |
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| Gender: Male or Female |
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| Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies |
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| Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx |
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| 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) |
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| Measurable disease |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 |
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| Adequate organ function |
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| Life expectancy of at least 12 weeks |
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| 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 |
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| 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 |
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| 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 |
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| Have PD-L1 IHC CPS status by central laboratory testing |
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| Have results from testing of human papilloma virus (HPV) status for oropharyngeal cancer |
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| Prior therapy with an anti-PD-1/L1/L2, anti-Inducible T Cell Co-Stimulatory Receptor (ICOS ) directed agent |
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| Systemic approved or investigational anticancer therapy within 30 days or 5 half lives of the drug, whichever is shorter |
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| Has high risk of bleeding |
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| Active tumor bleeding |
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| Grade 3 or Grade 4 hypercalcemia |
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| Major surgery <=28 days prior to randomization |
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| 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) |
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| Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization |
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| 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 |
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| 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 |
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| Autoimmune disease or syndrome that required systemic treatment within the past 2 years |
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| 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 |
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| Receipt of any live vaccine within 30 days prior randomization |
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| Prior allogeneic/autologous bone marrow or solid organ transplantation |
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| Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents |
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| Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions |
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| Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess |
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| Recent history of allergen desensitization therapy within 4 weeks of randomization |
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| History or evidence of cardiac abnormalities within the 6 months prior to randomization which include |
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| 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 |
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| Active infection requiring systemic therapy |
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| 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 |
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| History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation |
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| Known history of active tuberculosis |
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| Any serious and/or unstable pre-existing medical condition (aside from malignancy) |
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| 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 |
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| 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 |
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