Advances in immunotherapy have shown efficacy in various cancers. Immunotherapeutic approaches are becoming the new treatment modality in some cancer types. However, clinical efficacy is still limited to a marginal number of patients due to a newly developing understanding of the complex tumor microenvironment and a limited ability to appropriately select patients who have specific biomarker signatures and have the potential to optimally respond to specific immunotherapy or combination strategies. An additional challenge in assessment of biomarkers that show clinical utility to predict patient benefit includes the use of different methodologies and platforms that make it difficult to make accurate conclusions on the biomarkers in question. Thus, optimized biomarker strategies that can overcome immune barriers will allow tailoring of the therapeutic approaches and result in bold interventions that would be most beneficial to individual patients. The National Cancer Moonshot was launched in 2016 with the goal of boldly combating cancer beyond incremental advances leading to the creation of a ?Cancer Immunotherapy Translational Science Network? that would facilitate translational research and clinical advances in immunotherapy. Our proposal to create a resource center, named Translational Cancer Immune Monitoring and Analysis Center (TCIMAC) that will be a critical resource capable of serving any of the NCI-supported clinical trial networks. The TCIMAC will be co-led by Drs. Ignacio Wistuba, renowned cancer surgical and molecular pathologist, Elizabeth Mittendorf, well-known breast cancer surgeon and immunologist, and Chantale Bernatchez, cancer immunologist. They will be supported by a team that encompasses a multidisciplinary group of world-class and highly collaborative experts on cancer and immunotherapy. The main goals of TCIMAC are to: 1) provide centralized and harmonized services for sample collection, processing and quality assurance, and 2) use analytically-validated and standardized assays and platforms to offer state-of-the-art analyses for patients enrolled on NCI- sponsored early phase immunotherapy clinical trials.
In Aim 1, we will assist in standardizing bio-banking activities and share/develop standard operation procedures (SOPs) for biospecimen collection, processing, quality assessment, and storage of biospecimens collected from NCI-sponsored early phase immunotherapy clinical trials and to link the specimens to relevant clinical, pathological, immune and molecular data within the TCIMAC-CIDC Network.
In Aim 2, we will provide services to conduct both routine and innovative pathological, immunological and molecular analyses using standardized and validated assays to aid the completion of NCI- sponsored trials.
In Aim 3, we will provide comprehensive biostatistics and computational services for data collection and analysis for each analytical platform, and to perform analyses, interpretation and predictive modeling of high dimensional (`omic?) data in the context of clinical outcomes. We envision that the TCIMAC will be an indispensable element as we make meaningful progress in cancer immunotherapeutic approaches.
Novel immunotherapies show promise in some cancers in which they have demonstrated a significant clinical benefit although evidenced only in a minority of patients. Current immunotherapeutic approaches are mostly unsuccessful due to limited understanding of the tumor microenvironment, limited clinical utility of current immune markers and inconsistent use of assays or technologies that produce meaningful interpretations in studies. The Translational Cancer Immune Monitoring and Analysis Center (TCIMAC) will provide centralized and harmonized services for sample collection, processing and quality assurance and use analytically-validated and standardized assays and platforms to offer state-of-the-art analyses for phenotypic, genomic, and functional characterization of responses of patients enrolled on NCI-sponsored early phase immunotherapy clinical trial leading to the identification of biomarkers that will ultimately improve the therapeutic strategies for cancer patients.