A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-Cell Lymphomas
Primary Objectives: - To determine the anti-tumor activity of combination therapy with CDX-1127 (varlilumab) and nivolumab as compared to nivolumab alone in patients with advanced aggressive B-cell non-Hodgkin lymphomas (NHL) based on the lymphoma response to immunomodulatory therapy criteria or LYRIC (Cheson et al., 2016). Secondary Objectives - To assess the safety and tolerability profile of treatment with a combination of CDX-1127 (varlilumab) and nivolumab in patients with advanced aggressive B-cell NHL. - To evaluate the duration of response, progression-free survival and overall survival Exploratory Objectives - To determine the effect of combination therapy with CDX-1127 (varlilumab) and nivolumab on the immune system as assessed by immunohistochemistry (IHC), mass cytometry (CyTOF), changes in serum cytokine profile and immunogenicity assays. - To describe the pharmacokinetic profile of CDX-1127 (varlilumab) and nivolumab when used in combination -
BMS-936558 (Nivolumab); Nivolumab (Opdivo); Varlilumab ()
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