A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors
Mené sur 51 patients atteints d'un carcinome du rhinopharynx de stade avancé ou récidivant ou d'une autre tumeur solide, cet essai de phase I/II évalue la dose maximale tolérée du nivolumab et analyse ses caractéristiques pharmacocinétiques
Background : This phase I/II study investigated the safety and pharmacokinetics (PK) of nivolumab (anti‐programmed cell death‐1 monoclonal antibody) in Chinese patients with nasopharyngeal carcinoma (NPC) and other solid tumors. Methods : A dose evaluation phase (3 mg/kg once every 2 weeks [Q2W]) was followed by a cohort expansion phase (3 mg/kg Q2W or flat doses of 240 mg Q2W or 360 mg once every 3 weeks). Results : In the dose evaluation phase, 8/8 patients completed one cycle with no dose‐limiting toxicities. At data cutoff, 46/51 patients were evaluable for safety (all cohorts). Treatment‐related adverse events (TRAEs) occurred in 35 (76%) patients and were primarily grade 1–2; one patient (3 mg/kg Q2W) discontinued because of study drug toxicity. Intensive PK profiles at 3 mg/kg, 240 mg, and 360 mg were well characterized at single and multiple doses of nivolumab. An objective response was determined in six (6/46) patients, four (4/32) of whom had NPC tumors. Conclusion : Nivolumab monotherapy at 3 mg/kg and flat doses of 240 mg and 360 mg were well tolerated in this Chinese patient population, with PK profiles at 3 mg/kg being similar to those of global patients. Preliminary efficacy results showed promising antitumor activity of nivolumab in advanced NPC.
The Oncologist 2019