At a glance
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A Phase II, Open-label, Randomized Controlled Study of PDR001 in Patients With Moderately Differentiated/Undifferentiated Locally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma Who Progressed on Standard Treatment
In Brief
A Phase 2 clinical trial evaluating Spartalizumab and Investigator choice of chemotherapy for Nasopharyngeal Carcinoma. Completed, enrolled 122 participants across 18 sites in 7 countries.
Detailed Summary
The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001 versus investigator's choice of chemotherapy in patients with advanced nasopharyngeal carcinoma (NPC). By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the activation of a T-cell mediated antitumor immune response.
Study Details
Timeline
Interventions
Spartalizumab was administered via intravenous infusion at a dose of 400 mg every 4 weeks (Q4W). Spartalizumab is a humanized anti-PD-1 IgG4 antibody which blocks the binding of PD1 to its ligands PD-L1 and PD-L2.
Commonly used chemotherapy as per investigator's choice. The dose and route of administration was the one described in each drug's label.