On behalf of the society and the SITC Intratumoral Immunotherapy Clinical Trials Manuscript Development Group, we are pleased to announce the publication of a new manuscript “Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from pre-malignant to metastatic disease” in the Journal for ImmunoTherapy of Cancer.
While intratumoral immunotherapies have the potential to boost anti-tumor immune responses to overcome immunosuppressive tumor microenvironments, phase III trials evaluating them in late-stage disease have had limited success to-date, in part due to the complex nature of these trials not fully adapted to assess local therapies. The aim of this manuscript is to provide guidance on how to design trials with the greatest likelihood of demonstrating the benefits of intratumoral immunotherapy across all stages of pathogenesis, and ultimately bring more effective treatment options to patients.
Expert Panel Recommendations for Trial Design
To address challenges in intratumoral immunotherapy clinical trial design, an Expert Panel comprised of an international group of leaders from academia and industry convened to develop guidance on a variety of design elements including:
• Patient stratification factors
• Exclusion criteria
• Study arm considerations
• Optimal endpoints
• Response assessment
• Patient populations to prioritize
Supplemental Guidance on Localized Therapy Administration
In addition, the manuscript also provides an illustrated supplement that instructs users on the proper administration of localized immunotherapies for solid tumors and lymphomas, subcutaneous lymph nodes from lymphoma or metastatic tumors, accessible head and neck, liver, and breast lesions, and intravesical immunotherapy.