Study design, patient population, procedures, and outcomes
The phase Ib NIBIT-M4 study (NCT02608437) was conducted in accordance with the ethical principles of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice. The protocol was approved by the independent ethics committee of the University Hospital of Siena (Siena, Italy). All participating patients (or their legal representatives) provided signed informed consent before enrollment.We conducted a milestone, 5-year follow-up analysis of patients enrolled in the NIBIT-M4 study; the study design, patient eligibility criteria, and treatment regimen have already been described