The anti-PD1 antibody nivolumab is an established well tolerated, effective agent in mRCC. Given its favorable tolerability profile and proven ability to increase survival in more advanced disease, nivolumab is a rational option to investigate earlier in the micrometastatic setting, which is characterized by lower disease burden and a potentially more intact immune system.
The trial design is shown in figure 1. This will be a phase 3 open-label randomized study that is not placebo-controlled. The primary endpoint will be recurrence-free survival. Furthermore, the authors will assess safety, tolerability, and quality of life endpoints. There will also be additional correlative science with immunohistochemistry and immunofluorescence analyses, assessment of the impact of inflamed vs. non-inflamed tumor, and assessment of the induction of tumor PD-L1 expression. Whole exome sequencing will be done to identify neoepitope signatures and characterize mutational patterns and frequency. Finally, quality of life will be measured and assessed as well.
Figure 1 – Trial scheme:
Presented by: Lauren Harshman, MD, ECOG - ACRIN Research group, Assistant Professor, Medicine, Harvard Medical School, Assistant Professor, Medical Oncology, Dana-Farber Cancer Institute, Dana-Farber Cancer Institute
Written By: Gina B. Carithers Founder and Publisher at UroToday.com
Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA