First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients

NCT06121401 | Active Not Recruiting Phase 4

• 1 other identifier: IRFMN-OVA-8542
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.

Conditions

Carcinoma, Ovarian Epithelial

Outcome Measures

Primary Outcomes (2)

• Proportion of patients treated with olaparib

  Define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics

  42 months

• Efficacy of olaparib

  Confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy. The efficacy will be evaluated in terms of PFS rate at 24 months. PFS will be defined as the time from the start of olaparib therapy until disease progression or death whichever comes first

  42 months

Study Arms (1)

Olaparib - Bevacizumab

OTHER

Olaparib 300 mg 2\*daily + Bevacizumab 15mg/kg (q3w)

Drug: Olaparib; Drug: Bevacizumab

Interventions

Olaparib DRUG

Olaparib is considered the study treatment. Olaparib tablets will be taken at the dose of 300 mg (2 x 150 mg tablet) twice daily adding to bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks

Also known as: Lynparza

Olaparib - Bevacizumab

Bevacizumab DRUG

Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks

Olaparib - Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who has completed first line platinum-taxane chemotherapy
• Patient on treatment with bevacizumab (patient must have received at least 1 cycle of bevacizumab in combination with chemotherapy). Bevacizumab treatment should have been administered at a dose of 15mg/kg q3 weeks.
• Patient must be without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment.
• Patients with histologically confirmed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer and HRD-positive tumor according to the Myriad Mychoice CDx Plus evaluation.
• Patients must have normal organ and bone marrow function values measured within 28 days before administration of olaparib
• Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg
• \. Patients must have a life expectancy ≥ 16 weeks. 9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start.

You may not qualify if:

• Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
• Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required
• Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Patients with known active hepatitis (i.e. Hepatitis B or C).
• Any previous treatment with PARP inhibitor, including Olaparib.
• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib.
• Major surgery within 2 weeks of starting olaparib and patients must have recovered from any effects of any major surgery
• Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
• Concomitant use of known strong CYP3A inhibitors
• Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• Patients with a known hypersensitivity to olaparib or any of the excipients of the product.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• AstraZeneca: collaborator

Study Sites (2)

Azienda Socio Sanitaria Territoriale (ASST) Lariana

San Fermo della Battaglia, Como, 22042, Italy

Location

Istituto Oncologico Veneto IRCCS

Padua, Italy, 35128, Italy

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

olaparib; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Federica Tomao

  Università degli Studi di Roma "La Sapienza", Viale del Policlinico 155, Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 7, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

IT (2)