While treatment with immune checkpoint inhibitors (ICI) is generally expected to positively impact the length and quality of patients’ lives, up to 72 percent of patients whose cancer is being treated using ICIs experience dermatological immune related adverse events (D-irAEs) that can cause painful skin conditions. Biomarkers that lead to better monitoring and treatments for the subset of patients who experience D-irAEs are needed, but the clinical and immunologic characteristics that predict risk must be defined. In addition, research evaluating irAEs has historically been in small studies, which are limited in their ability to definitively prove the validity and generalizability of a biomarker to predict D-irAEs in multiple cancer contexts.

To address this need, the D-irAEs team proposes a multi-institutional translational research project to create unified disease definitions for D-irAEs and to characterize D-irAEs clinically, histologically and immunophenotypically. The project is expected to use a combination of real-world health data and biospecimens from cancer patients with D-irAEs to identify risk factors of and biomarkers associated with D-irAEs, helping tailor future ICI therapies to cancer patients. The partnership will include co-Principal Investigators from multiple research institutions to lead each aim, leadership from Project Data Sphere, contribution of valuable, existing sample resources by the National Cancer Institute’s (NCI) Alliance Biorepository to increase the scale of the results, and project management by the Foundation for the National Institutes of Health (FNIH). If successful, the results from this work will allow oncologists to monitor at-risk patients in order to tailor future cancer immunotherapies, alleviate prevalent adverse drug reactions, and minimize interruption of treatment.

  • The aim of this project is to develop and validate new methods of D-irAE classification and management in ICI-treated patients.

  • 1. Clinical phenotyping: Accrue and analyze a first-in-class, multi-institutional registry of patients and associated biobank of clinical specimens with D-irAEs from ICI-treated patients that include factors most pertinent to clinical care.

  • 2. Germline risk profiling: Integrate clinical and genomic risk prediction models of development of D-irAEs in patients and downstream clinical outcomes.

  • 3. Digital pathology: Mechanism-focused cell and molecular analysis of lesional skin of ICI-treated patients with specific D-irAES.

  • The D-irAEs project is expected to advance understanding of the pathogenesis of D-irAEs, improve risk assessment of patients receiving cancer immunotherapy in order to better direct resources, develop less invasive methods for the differential diagnosis of D-irAEs, and improve clinical care of patients receiving cancer immunotherapies.

Partner with Us

The FNIH actively seeks private-sector funding and budget-relieving in-kind resources to support the D-irAEs project. The project requires $3.4M in private funds over two years. The below chart outlines the contributions necessary for participation as a full-funding partner. The range of necessary financial contributions is ultimately dependent upon the number of participating funding partners.

Full-funding partners may have multiple participants on the Project Team and may cast one vote per organization on project decisions. Throughout the life of the project, the FNIH will work to ensure that all partners have ample opportunity to provide input and share valuable expertise. Active participation and broad acknowledgment of all private partners will be facilitated through:

  • Participation on the Project Team and in regular Project Team teleconferences
  • Progress reports provided by the Project PIs and at least one face-to-face meeting per year
  • Collaboration with FNIH staff to ensure recognition in press releases, project-related print materials, the FNIH annual report, and the fnih.org website.

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