Ovarian CancerPhase 2STROBENCT06377267
Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)
A Phase 2 study testing Bevacizumab and Olaparib in people with Ovarian Cancer, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2024to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with newly diagnosed high- grade serous or endometrioid Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer. I-3-3 At an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification (see appendix 1).
- Patient who has completed prior to enrollment first line platinum-taxane chemotherapy:
- Platinum-taxane based regimen must have consisted of
- 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 toxicityspecificallyrelated to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
- 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.
- Patient must be prior to enrollment without evidence of disease (NED) or in complete response (CR) or partial response (PR) from the first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout he first line treatment and prior to study enrollment.
Show all 10Show fewer
- Patient must be randomized at least 4 weeks and no more than 8 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from theprevious chemotherapy must have resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy).
- Patient must have normal organ and bone marrow function:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see appendix 3)
- Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification.
Who cannot join
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
- Ovarian tumors of low malignant potential (e.g. borderline tumors) or mucinous carcinoma.
- Other malignancy within the last 5 years except:
- Patient with myelodysplastic syndrome/acute myeloid leukemia history.
- Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery.
- Any previous treatment with PARP inhibitor, including olaparib.
Show all 21Show fewer
- Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
- Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
- Clinically significant (e.g. active) cardiovascular disease, including:
- Myocardial infarction or unstable angina within ≤ 6 months of enrollment,
- New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF) (see appendix 5).
- Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG,
- Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to enrollment.
- History or evidence of hemorrhagic disorders within 6 months prior to enrollment.
- History or clinical suspicion of brain metastases or spinal cord compression.
- Significant traumatic injury during 4 weeks prior to enrollment.
- Non-healing wound, active ulcer or bone fracture.
- History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.
- Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
- Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron Institute of Oncology
Barcelona
Ana Oaknin
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Bevacizumab, Olaparib
- Keywords
- HRD status
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab dosing is at 15 mg/kg every 3 weeks as an intravenous infusion.
OlaparibDrug
Olaparib dosing is oral at 300 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| HRD positive arm | Experimental | Patient with harboring HRD tumor, that will receive olaparib in combination with bevacizumab Receives: Drug: Bevacizumab; Drug: Olaparib |
| HRD negative arm | Other | Control group receiving bevacizumab alone as standard of care.Patient with non harboring HRD tumor, that will receive bevacizumab Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution
The primary outcome measure description would outline the method used to evaluate the agreement in HRD status identification between the VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution. This would include details on how HRD status is determined and compared between the two tests, along with any statistical analyses employed to measure the level of agreement.
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (5)
Performance Assessment of VHIO-CARD-300 Test for HR Status Identification
This secondary outcome measure focuses on evaluating the performance of the VHIO-CARD-300 test as a diagnostic tool for identifying HR status. The assessment will include determining the sensitivity, specificity, and predictive positive and negative values of the VHIO-CARD-300 test, with the SOPHiA DDM™ Dx HRD Solution serving as the reference standard.
Measured: Through study completion, an average of 1.5 years
Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes.
To assess the relationship between the HRD positive and HRD negative groups identified by the VHIO-CARD-300 test and treatment efficacy outcomes.
Measured: Through study completion, an average of 1.5 years
Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases
This outcome measure aims to assess the efficacy outcomes in cases where there is a discrepancy between the results obtained from the VHIO-CARD-300 test and the SOPHiA DDM™ Dx HRD Solution. Specifically, it focuses on cases where a patient is classified as HRD positive by one test but HRD negative by the other, and vice versa. The primary efficacy endpoints, progression-free survival (PFS) and overall survival (OS), will be analyzed in these discrepant cases to evaluate the impact of the discordant results on clinical outcomes
Measured: Through study completion, an average of 1.5 years
Safety and Tolerability of Olaparib Plus Bevacizumab
Assessment of adverse events (AEs) graded by the National Cancer Institute (NCI) CTCAE v5.0, serious adverse events (SAEs), abnormal vital signs, abnormal ECG results, and evaluation of laboratory parameters
Measured: Through study completion, an average of 1.5 years
To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution.
Percentage of inconclusive results will be estimated for each test
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start6 Feb 2024
- Primary completion1 Mar 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Oaknin, Principal investigator, Vall d'Hebron Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377267
- Sponsor's protocol ID
- ESR-20-21103
- Acronym
- STROBE
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377267
- Acronym / sponsor ID
- STROBE / ESR-20-21103
- Conditions
- Ovarian Cancer
- Keywords
- HRD status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRD positive arm | Experimental | Drug: Bevacizumab, Drug: OlaparibPatient with harboring HRD tumor, that will receive olaparib in combination with bevacizumab |
| HRD negative arm | Other | Drug: BevacizumabControl group receiving bevacizumab alone as standard of care.Patient with non harboring HRD tumor, that will receive bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with newly diagnosed high- grade serous or endometrioid Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer. I-3-3 At an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification (see appendix 1).
- Patient who has completed prior to enrollment first line platinum-taxane chemotherapy:
- Patient must be prior to enrollment without evidence of disease (NED) or in complete response (CR) or partial response (PR) from the first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout he first line treatment and prior to study enrollment.
- Patient must be randomized at least 4 weeks and no more than 8 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from theprevious chemotherapy must have resolved to CTCAE grade 1 or better (except alopecia and peripheral neuropathy).
- Patient must have normal organ and bone marrow function:
Key exclusion criteria (21 listed)
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
- Ovarian tumors of low malignant potential (e.g. borderline tumors) or mucinous carcinoma.
- Other malignancy within the last 5 years except:
- Patient with myelodysplastic syndrome/acute myeloid leukemia history.
- Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabBevacizumab dosing is at 15 mg/kg every 3 weeks as an intravenous infusion. | Drug | HRD negative arm, HRD positive arm |
| OlaparibOlaparib dosing is oral at 300 mg twice daily | Drug | HRD positive arm |
Primary outcome
Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution
Time frame: Through study completion, an average of 1.5 years
The primary outcome measure description would outline the method used to evaluate the agreement in HRD status identification between the VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution. This would include details on how HRD status is determined and compared between the two tests, along with any statistical analyses employed to measure the level of agreement.
5 secondary outcomes
Performance Assessment of VHIO-CARD-300 Test for HR Status Identification
Time frame: Through study completion, an average of 1.5 years
Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes.
Time frame: Through study completion, an average of 1.5 years
Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases
Time frame: Through study completion, an average of 1.5 years
Safety and Tolerability of Olaparib Plus Bevacizumab
Time frame: Through study completion, an average of 1.5 years
To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution.
Time frame: Through study completion, an average of 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Oaknin principal investigator
Vall d'Hebron Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Olaparib in people with Ovarian Cancer, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Oaknin (+34 934893000 ext. 2658, aoaknin@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution (time frame: Through study completion, an average of 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.