Actively Recruiting
Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-05-09
100
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with newly diagnosed high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer at advanced FIGO stage IIIB, IIIC, or IV
- Completed first-line platinum-taxane chemotherapy with 6 to 8 cycles, or at least 4 cycles if stopped early due to non-hematological toxicity
- Received at least 3 cycles of bevacizumab combined with the last 3 cycles of platinum chemotherapy, or 2 cycles in case of interval debulking surgery
- No evidence of disease or in complete or partial response after first-line treatment with no progression detected
- Randomized between 4 to 8 weeks after last chemotherapy dose with all major toxicities resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy)
- Normal organ and bone marrow function
- ECOG performance status of 0 or 1
- Available formalin fixed, paraffin embedded tumor sample for central BRCA testing with results for stratification
You will not qualify if you...
- Non-epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., germ cell tumors)
- Ovarian tumors of low malignant potential, including borderline tumors or mucinous carcinoma
- Other malignancy within the last 5 years except specified exceptions
- History of myelodysplastic syndrome or acute myeloid leukemia
- Major surgery within 4 weeks before study treatment without full recovery
- Prior treatment with any PARP inhibitor, including olaparib
- Using potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin, or nelfinavir
- History of hypertensive crisis or hypertensive encephalopathy
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, NYHA grade 2 or higher heart failure, poorly controlled arrhythmia, or severe peripheral vascular disease
- Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within 6 months
- History or signs of hemorrhagic disorders within 6 months
- Brain metastases or spinal cord compression
- Significant traumatic injury within 4 weeks prior to enrollment
- Non-healing wounds, active ulcers, or bone fractures
- History of abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding related to VEGF therapy within 6 months
- Current clinically relevant bowel obstruction related to disease
- Evidence of unexplained abdominal free air
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vall d'Hebron Institute of Oncology
Barcelona, Spain
Actively Recruiting
Research Team
A
Ana Oaknin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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