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

NCT06377267 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab dosing is at 15 mg/kg every 3 weeks as an intravenous infusion.

DRUG

Olaparib

Olaparib dosing is oral at 300 mg twice daily

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Principal Investigators

  • Ana Oaknin · Vall d'Hebron Institute of Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-03-01
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377267 on ClinicalTrials.gov