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

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT06377267
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab dosing is at 15 mg/kg every 3 weeks as an intravenous infusion.
  • Olaparib — DRUG
    Olaparib dosing is oral at 300 mg twice daily

Study Details

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.

Key Dates

Start date
Feb 6, 2024
Status verified
May 2024
Primary completion
Mar 1, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HRD positive arm
    Patient with harboring HRD tumor, that will receive olaparib in combination with bevacizumab
  • Other: HRD negative arm
    Control group receiving bevacizumab alone as standard of care.Patient with non harboring HRD tumor, that will receive bevacizumab

Primary Outcome Measure

Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution [ Time Frame: Through study completion, an average of 1.5 years ]

Central Contacts

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