NCT06377267

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

Non-Randomized, Open-Label, Prospective Phase II Trial to Better Characterize the Status of HRD Leading to a Benefit From Olaparib in Combination With Bevacizumab in Patients With Advanced FIGO Stage III-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer After Standard First-Line Treatment

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vall d'Hebron Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This non-randomized, open-label phase II trial seeks to enhance our understanding of HRD status in patients with advanced ovarian, fallopian tube, or peritoneal cancer. Following standard first-line treatment, participants will be assessed for HRD status using the VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution. Those identified as HRD-positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone as per standard care. The study aims to determine the concordance between the two HRD tests, evaluate the efficacy of the olaparib-bevacizumab combination, and assess safety and tolerability. Efficacy outcomes will be evaluated using RECIST criteria, with a minimum follow-up of 30 months post-enrollment. Secondary objectives include examining treatment accuracy, association with efficacy outcomes, and analyzing discrepant cases. Overall, this trial aims to provide valuable insights into personalized treatment approaches for patients with advanced ovarian cancer.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-06
• Primary completion: 2024-03-01
• Completion: 2025-09-01
• First posted: 2024-04-22
• Last updated: 2024-05-09

Locations

1 site across 1 country: Spain