Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies A Multicenter Cancer Biospecimen Collection Study

What this Trial Is About

Researchers are collecting de-identified tumor samples along with clinical and demographic data from cancer patients who have had or are scheduled for a tumor biopsy before starting treatment with PD-1/PD-L1 inhibitors. The study aims to use these samples and information to develop and validate a diagnostic test that may help predict how patients respond to immunotherapy. This observational study involves multiple types of cancer including head and neck, lung, breast, and others. Participants are included if they have one of several specified cancers and have undergone or will undergo a tumor biopsy before beginning anti-PD-1/PD-L1 treatment. The study does not require extra biopsies beyond those collected as part of standard care. Patients must have had medical imaging of the tumor before treatment and provide consent for their tissue and data to be used in related future studies. The main diagnostic tool studied is the OncoPrism™ assay, which analyzes the immune components of tumor tissue. During the study, participants' tumor specimens and medical data are collected and de-identified to protect privacy. Researchers will review how patients respond to PD-1/PD-L1 inhibitors over six months. No additional treatments or procedures are required beyond standard care and consent. The study is sponsored by Cofactor Genomics, Inc., and participation involves tracking tumor biopsy samples and clinical outcomes over time until the study ends in February 2027.

A Multicenter Cancer Biospecimen Collection Study