A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Evelyn Cantril, CRA
402-559-7507
ecantril@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06580314?term=NRG-GY036&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine investigator assessed progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (non-inferiority) for one versus (vs.) two years of maintenance olaparib.
SECONDARY OBJECTIVES:
I. To evaluate overall survival (OS360) in the modified intent to treat (ITT) population, with time at risk for progression/death starting 360 days after randomization.
II. To evaluate progression-free survival (PFS), PFS2 and overall survival (OS) in the ITT population.
III. To evaluate PFS, PFS2, and OS in the as-treated population. IV. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population.
EXPLORATORY OBJECTIVE:
I. To evaluate the moderating effect of physician-choice bevacizumab (as stratified) on randomized treatment effect estimates.
TRANSLATIONAL OBJECTIVES:
I. To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid (ctDNA) as a predictor of poor response in the BRCA mutated (BRCAm) population.
II. To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair (HRR) genes with clinical homologous recombination deficiency (HRD) testing and outcomes in the BRCA wildtype (BRCAwt) population.