January 18 2023
Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer (NCT#03738228)
The NRG-GY017 was designed to assess whether differing sequences of atezolizumab and chemoradiation help boost immune activity and improve outcomes for women with node-positive, locally advanced cervical cancer. This trial recently completed accrual and preliminary results were reported as a plenary oral session at the Society of Gynecology Oncology (SGO) 2022 meeting in the spring.The updated translational data and analysis will be presented by Dr. Dmitriy Zamarin, MD, PhD, principal translational PI on the study, as a plenary oral session at this year’s SGO 2023 meeting.
Patients with locally-advanced cervical cancer typically have a higher risk of recurrence and worse survival outcomes than patients who present at an earlier stage. Typically, patients with this disease type are treated with cisplatin chemotherapy and radiation followed by internal radiation or brachytherapy. Only 30-40% of patients are alive or cancer-free at 5 years following treatment with the standard of care. Due to the correlation between cervical cancer and infections by viral subtypes such as human papilloma virus (HPV), there is demonstrated evidence in this disease type that the addition of a checkpoint inhibitor has the ability to restore T cell function and immune T cell priming.
“NRG-GY017 aims to utilize atezolizumab and translational science to better understand which patients respond to checkpoint inhibition to potentially improve outcomes for this high risk for recurrence patient population,” stated Jyoti Mayadev, MD, of the University of California, San Diego and the Principal Investigator of the NRG-GY017 study. “We also want to determine the best timing and method for delivering the study drug in conjunction with the chemotherapy and radiation used.”
NRG-GY017 accrued 40 patients 18 or older with newly-diagnosed, node-positive, advanced cervical cancer that were not recommended for surgery. Trial participants were randomly assigned to receive either atezolizumab 3 weeks prior to chemoradiation and atezolizumab on day 0 and 21 of the radiation, or atezolizumab on the first day of chemoradiation and day 21 and 42 of the chemoradiation.
In addition to assessing the different sequencing of atezolizumab relative to chemoradiation, NRG-GY017 will test the feasibility, nature and degree of toxicity for administration of atezolizumab as an immune primer and concurrent with chemoradiation, examine the changes in TCR clonality, diversity, and frequency in peripheral blood and tissue and correlate this to clinical outcomes, and determine the predictive value of baseline and on-treatment PD-L1 expression in tissue in each treatment arms for clinical outcomes.
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website