January 12 2022
Cervical cancer accounts for approximately 266,000 deaths globally each year and patients diagnosed with locally-advanced cervical cancer have a higher risk of recurrence and worse survival than early stage patients. Additionally, patients presenting with para-aortic lymph node (PALN) metastases represent a poor prognostic group with only a 5-year survival of approximately 40% across the stages. The NRG Oncology clinical trial NRG-GY017 was designed to address the need for a therapeutic treatment option for this patient population.
NRG Oncology’s clinical trial NRG-GY017 completed accrual and is currently compiling and analyzing data. The outcomes from this study are to be presented as a Plenary Session presentation at the upcoming Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in March 2022.
NRG-GY017 observed the anti-PD-L1, atezolizumab, as an immune system activation for women with node-positive, locally advanced cervical cancer. Women on this trial received atezolizumab either before and/or concurrent with cisplatin chemotherapy and the standard of care radiotherapy with image-guided brachytherapy.
The primary goal of NRG-GY017 is to determine whether the difference in sequencing for the addition of atezolizumab to chemoradiotherapy results in differential immune activation for trial participants. Differential immune activation will be determined by clonal expansion of T cell receptor beta repertoires in peripheral blood on day 21 of treatment.
Other objectives include: investigating the feasibility of administrating atezolizumab as an immune primer and concurrent with chemoradiotherapy, the nature and degree of toxicity from atezolizumab prior and concurrent with chemoradiotherapy, changes in the T cell receptor clonality, diversity, and frequency in peripheral blood and tissue and the correlation of these changes to clinical outcomes, and lastly the predictive value of baseline and PD-L1 expression in tissue in each treatment arms for clinical outcomes. Exploratory objectives are to explore biomarkers that could predict a response to the combination therapy and to explore the response of assessment on the exploratory and optional post-treatment PET-CT scan, and the clinical 2-year disease free survival.
“This trial is of paramount importance to understand the optimal sequencing and underlying immune mechanism when immunotherapy is added to the standard of care chemoradiation in locally advanced cervical cancer,” mentioned the trial’s Study Chairs, Jyoti Mayadev, MD, of the University of California, San Diego and Russell Schilder, MD, of Thomas Jefferson University, and Dmitiry Zamarin, MD, PhD, of Memorial Sloan Kettering Cancer Center.
More information:
ClinicalTrials.gov: NCT03738228