Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) - Trial NCT06377267

Timeline & Enrollment

Primary Outcome

Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution

Summary

Background:
 
 The study aims to address the challenge of accurately identifying patients with ovarian
 cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance
 therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown
 significant benefits from PARPi treatment, the efficacy in homologous recombination deficient
 (HRD) patients remains inconclusive. Current assays used to estimate HR status do not
 effectively differentiate between patients who benefit most from PARPi and those who do not,
 making it inefficient to treat all patients. There is a need for a more accurate HR status
 testing method to optimize PARPi benefit. This study aims to assess the performance of the
 VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.
 
 Summary:
 
 The study is a prospective, non-randomized trial designed to evaluate the concordance of the
 VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution.
 Additionally, it aims to assess the association between HRD status determined by the
 VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high
 grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to
 participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx
 HRD Solution. Patients classified as HRD positive will receive olaparib in combination with
 bevacizumab, while others will receive bevacizumab alone. Treatment will be administered
 according to approved doses, with follow-up evaluations conducted until RECIST progression.

ICD-10 Classifications