A window of opportunity trial evaluating intratumoral injection of Copaxone® in patients with percutaneously accessible tumors

Background This window of opportunity trial evaluated the safety of intratumoral Copaxone® and profiled immune markers in biopsies before and after treatment. Methods Patients with percutaneously accessible malignancies scheduled for surgical resection with curative intent were eligible to participate. Adverse events from one, two, or three injections of Copaxone® were monitored leading up to surgical resection. Using RNA sequencing and spatial protein profiling of immune-related targets, changes in mRNA and protein expression patterns, respectively were assessed in tumor biopsy samples pre- and post-treatment. Results Adverse events at the injection site were mild and consistent with historic subcutaneous administration of Copaxone®. Increased intratumoral immune activity was evident in most patients, including the upregulation of genes associated with immune stimulation and targets of checkpoint inhibitor therapy. Conclusions Intratumoral injection of Copaxone® was well tolerated, and immune profile changes in the tumor microenvironment warrant its further evaluation as human intratumoral immunotherapy. Trial registration clinicaltrials.gov, NCT03982212 First posted June 11 th , 2019