OncoMatch/Clinical Trials/NCT06377267
Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)
Is NCT06377267 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bevacizumab and Olaparib for ovarian cancer.
Treatment: Bevacizumab · Olaparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: BRCA1 testing required
FFPE tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification
Required: BRCA2 testing required
FFPE tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification
Disease stage
Required: Stage IIIB, IIIC, IV
Grade: high-grade
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (platinum, taxane) — first line
Patient who has completed prior to enrollment first line platinum-taxane chemotherapy: minimum of 6 treatment cycles and a maximum of 8. However, if platinum-based therapy must be discontinued early as a result of non-hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
Must have received: VEGF-targeted therapy (bevacizumab) — in combination with last 3 cycles of platinum-based chemotherapy
Patient must have received prior to enrollment a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Only in case of interval debulking surgery, it is allowed to realize only 2 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy.
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with PARP inhibitor, including olaparib
Lab requirements
Blood counts
normal organ and bone marrow function required
Kidney function
normal organ and bone marrow function required
Liver function
normal organ and bone marrow function required
Patient must have normal organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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