Clinical Assessments
Tumors, tumor
TUMORS, ADVERSE EVENT, SYSTEMIC DISEASE, TUMOR
The primary objective was to assess the safety and tolerability of IT GLA-SE in combination with radiotherapy using the Common Terminology Criteria for Adverse Events, version 5.0. Secondary objectives were to assess the clinical efficacy of local and systemic disease control as well the immunologic effects. Assessment of tumor responses was performed for both target and noninjected lesions according to RECIST (Response Evaluation Criteria in Solid Tumors), version 1.1. Imaging and biopsies were performed at baseline before treatment and after the eighth dose. After this, imaging was performed every 6 weeks for 4 scans, then every 12 weeks after that, until progression.