Immune correlates in peripheral blood samples in a preoperative window of opportunity randomized trial of nivolumab with or without tadalafil in resectable squamous cell carcinoma of the head and neck (SCCHN)
Abstract
Abstract Background Immune checkpoint inhibitor therapy is approved for the management of recurrent/metastatic SCCHN. However, only a subset of patients derive clinical benefit from these therapies. As an exploratory analysis in the context of a window-of-opportunity randomized trial of nivolumab in combination with the PDE5 inhibitor tadalafil, an agent that has been reported to shift immune bias in SCCHN patients, we probed immune signatures in peripheral blood and tumor samples. The complete clinical trial results as well as analysis of tumor tissue samples are reported separately. Methods Blood and fresh tumor samples were collected from 28 patients receiving either nivolumab alone (n = 12) or nivolumab and tadalafil (n = 16) for 4 weeks prior to surgery. Immune cell phenotypes were obtained from PBMC after red blood cell lysis using fluorescent-based flow cytometry. Plasma and short-term culture supernatant from pre-treatment biopsies and surgical specimens were analyzed by multiplex luminex analyses. Patients were segregated based on treatment group or radiographic response. Results Over the 4-week treatment period nivolumab altered levels of a broad range of immune mediators and this signature was slightly affected by tadalafil. Preliminary principal component analysis suggest predictive pre-treatment immune signatures consistent with T cell activation, type 1 immunity, and soluble forms of immune checkpoint receptors. As determined by FACS analysis those patients who…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 28 participants or records.
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