A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
- Histologically or cytologically confirmed nasopharyngeal carcinoma.
- Subjects with primary metastatic (nasopharyngeal carcinoma, stage IVB defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System edition 8) nasopharyngeal carcinoma who are not suitable for local treatment or radical treatment; or nasopharyngeal carcinoma subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the end of previous radical treatment (radiotherapy with induction, concurrent, adjuvant chemotherapy)；No systemic treatment has been received for recurrent or metastatic nasopharyngeal carcinoma, and local regional recurrence is not suitable for local treatment or has received local treatment.
- Subjects with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
- Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
- Active or untreated CNS metastases.
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