NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Not open
Phase: III (Cancer Control)
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07061977?term=NCT07061977&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiation therapy (CCRT) + IO improves progression-free survival (PFS) compared to CCRT+IO alone.
SECONDARY OBJECTIVES:
I. To assess whether induction IO and chemotherapy prior to CCRT+IO improves the overall survival (OS) compared to CCRT+IO alone.
II. To determine the nature and degree of toxicity of induction IO and chemotherapy prior to CCRT + IO as compared to concurrent CCRT+IO as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
III. To determine the impact on CCRT start, CCRT completion time, and number of cycles of cisplatin administered; with induction IO and chemotherapy prior to CCRT+IO arm as compared to CCRT+IO.
IV. To assess the association between allostatic load and PFS/OS. V. To assess the predictive value of the integrated biomarker: PD-L1 expression at baseline for progression free survival.
VI. To assess the prognostic and predictive value of the integrated biomarker: circulating tumor deoxyribonucleic acid (ctDNA) at baseline and at 3 months post radiation therapy (RT) for progression free survival.
VII. To explore radiotherapy quality pretreatment scores conducted by expert review with assistance from artificial intelligence (AI) models and correlation with outcomes.
EXPLORATORY OBJECTIVES:
I. To assess the evolution of T cell receptor (TCR) repertoire on treatment and its correlation with clinical outcomes.
II. To identify pre-treatment tumor microenvironment biomarkers predictive of outcomes.