“QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination with a PD-1/PD-L1 Checkpoint Inhibitor in Patients who have Disease Progression Following an Initial Response to Treatment with PD-1/PD-L1 Checkpoint Inhibitor Therapy”
In this research study, you will receive a novel immunostimulatory protein complex called ALT-803/N-803 via subcutaneous injection in combination with any of the following checkpoint inhibitors: Pembrolizumab, Nivolumab, Avelumab, or Atezolizumab, based on your prior treatment regimen. The study treatment period will consist of sixteen 6-week cycles over a nearly 2 year period. Following the study treatment period, you will have an End-of-Study visit to collect follow-up information.
The purpose of this study is to determine the effectiveness and safety profile of this combination therapy in patients with advanced or metastatic cancer who have experienced an initial response to previous checkpoint inhibitor treatment and are now showing signs of disease progression.