AK105-304: This study is evaluating the safety and effectiveness of chemotherapy plus targeted therapy, compared to chemotherapy plus placebo, in people with recurrent or metastatic nasopharyngeal cancer.A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Exclusion

• Subjects with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
• Subjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
• Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
• Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
• Active autoimmune disease requiring systemic treatment within 2 years prior to initial administration, or as an autoimmune disease that can recur or for which treatment is planned determined by the investigator.
• Active or past history of definite inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
• History of immunodeficiency; those who test positive for HIV antibody; current chronic use of systemic corticosteroids or immunosuppressive agents.
• Known active tuberculosis (TB) (suspected of having active TB need to undergo clinical examination for exclusion of such possibility); known active syphilis infection.
• Known history of allotransplantation and allogeneic hematopoietic stem cell transplantation.
• Has known active Hepatitis B or Hepatitis C.
• Active or untreated CNS metastases.
• Subjects with peripheral neuropathy.
• Unresolved toxicity from prior anti-tumor therapy, defined as toxicity that has not recovered .
• Received a live vaccine within 30 days before the first dose or planned to receive a live vaccine during the study.
• Known allergy to any study drug component; known history of serious hypersensitivity to other monoclonal antibodies.
• Pregnant or nursing (lactating) women.