Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377267
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-10
Brief Title:
Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab STROBE Trial
Sponsor:
Vall dHebron Institute of Oncology
Organization:
Vall dHebron Institute of Oncology
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STROBE
Brief 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 BRCA12-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
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 BRCA12-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None