Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario (BeLIVE)

February 14, 2025 updated by: Consorzio Oncotech

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study

This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026.

  • Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.
  • Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination status using a validated HRD test between January 2021 and January 2026:

Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.

Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice. Alive patients who have finished the first line treatment (including maintenance) with or without disease progression while signing the informed consent form will be enrolled retrospectively. Alive patients candidate to receive a first line therapy will be enrolledprospectively as soon as molecular data (BRCA status and HRD) are available.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Università degli Studi di Napoli "Federico II"
        • Contact:
          • Roberto B Roberto Bianco, MD
          • Phone Number: 081 7461111 081 7461111
          • Email: robianco@unina.it
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
        • Contact:
    • BA
      • Bari, BA, Italy, 70124
        • Recruiting
        • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
        • Contact:
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola-Malpighi
        • Contact:
    • CN
      • Cuneo, CN, Italy, 12100
    • CT
      • Catania, CT, Italy, 95100
        • Recruiting
        • Azienda Ospedaliera Per L'Emergenza Cannizzaro
        • Contact:
    • FC
      • Meldola, FC, Italy, 47014
        • Recruiting
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
        • Contact:
    • FI
      • Firenze, FI, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitario Careggi
        • Contact:
    • GE
    • MB
      • Monza, MB, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori (Monza)
        • Contact:
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)
        • Contact:
      • Milano, MI, Italy, 20133
    • PD
      • Padova, PD, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto (IOV)
        • Contact:
    • PG
      • Perugia, PG, Italy, 06156
    • PN
      • Aviano, PN, Italy, 33081
        • Recruiting
        • Centro di riferimento oncologico - CRO di Aviano
        • Contact:
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Roma, RM, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena - Roma
        • Contact:
    • SV
      • Savona, SV, Italy, 17100
    • TO
      • Torino, TO, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano Umberto I
        • Contact:
    • UD
      • Udine, UD, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
        • Contact:
    • VE
      • Mestre, VE, Italy, 30174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with advanced high grade ovarian cancer who have received a homologous recombination analysis using validated HRD test between January 2021 and January 2026 are eligible. Patients resulted HRD and treated with Olaparib plus Bevacizumab will be included in Cohort A while patient with HRP tumors will be included in the Cohort B. Patients enrolled in the "compassionate use" of Olaparib (CNN program) can be included as well as patients who have received therapies according to clinical practice.

Description

Inclusion Criteria:

  • Female, age ≥ 18 years at the time of diagnosis

  • Patients diagnosed with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer undergone to Homologous Recombination test with the MyChoice HRD assay, FoundationOne DX assay or another validated HRD test, between January 2021 and January 2026:

    • Patients with HRD score > 42 or Loss of Heterozygosity (LOH) score high or defined as HR deficient with other tests and treated with Bevacizumab and Olaparib after first line platinumbased chemotherapy will be retrospectively or prospectively enrolled in Cohort A
    • Patients with HRD score < 42 or Loss of Heterozygosity (LOH) score low or defined as HR proficient with other tests and treated with first line platinum-based chemotherapy with or without bevacizumab or others targeted agents will be retrospectively or prospectively enrolled in Cohort B
  • Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Exclusion Criteria:

  • Patients who have not performed a validated Homologous Recombination test on tumor sample.
  • Patients with germline or somatic BRCA 1 or 2 mutations
  • Patients death at the time of inclusion in the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort A: Homologous Recombination Deficient (HRD)
Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.
Cohort B: Homologous Recombination Proficient (HRP)
Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the clinical outcomes
Time Frame: Until 3 years from enrollment

The clinical outcomes that will be measured in both study cohorts are:

progression-free survival (PSF) as the time from treatment's start to disease progression or death for any cause
Until 3 years from enrollment
Evaluate the clinical outcomes
Time Frame: Until 3 years from enrollment

The clinical outcomes that will be measured in both study cohorts are:

overall survival (OS) as the time from treatment's start to death for any cause
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Toxicity evaluated according to CTCAE vers 5.0
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Percentage of patients with dose reductions
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Percentage of patients with dose interruptions due to toxicity
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Percentage of patients with treatment discontinuations due to toxicity
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Toxicity according to initial dose of targeted agents
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Time Frame: Until 3 years from enrollment
Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi
Until 3 years from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the clinical outcomes
Time Frame: Until 3 years from enrollment
according to disease stage
Until 3 years from enrollment
Describe the clinical outcomes
Time Frame: Until 3 years from enrollment
according to surgical timing
Until 3 years from enrollment
Describe the clinical outcomes
Time Frame: Until 3 years from enrollment
according to residual disease after surgery in each cohort
Until 3 years from enrollment
Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
Time Frame: Until 3 years from enrollment
Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
Until 3 years from enrollment
Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)
Time Frame: Until 3 years from enrollment
Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)
Until 3 years from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Oncotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeLIVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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