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Study of Pembrolizumab n Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer
||A Two-arm, Open-label, Randomized Phase II Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)
Head and Neck Cancer
||Robert Martell, MD
This is a study of pembrolizumab versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.
The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.
- Must have non-keratinizing differentiated NPC or undifferentiated NPC
- Must have metastatic disease or incurable locally recurrent disease
- Must have had treatment with prior platinum therapy
- Must not be currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug
- Must not have diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Must not be experiencing adverse events due to therapy more than 4 weeks earlier
Subjects will receive treatment in in 3-week cycles for maximum 35 cycles. Tumor tissue will be obtained (if there is on archival tissue available) at screening. Blood for genetics and biomarker studies will be collected during Cycles 1, 2, 3 and at discontinuation. Tumor imaging will be done at screening, Cycles 2, 4, 6, discontinuation and follow-up visits.