PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer

March 11, 2026 updated by: N.N. Alexandrov National Cancer Centre

To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.

This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

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

  • Belarus
    • Lesnoy
      • Minsk, Lesnoy, Belarus, 223040
        • Recruiting
        • N.N. Alexandrov National Caner Centre
        • Contact:

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

Description

Inclusion Criteria:

  • Age ≥18-≤75 years.
  • Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Possibility of performing diagnostic laparoscopy or cytoreductive surgery.
  • Presence of homologous recombination deficiency (HRD).
  • No contraindications to chemotherapy, or bevacizumab.
  • Signed informed consent to participate in the study.

Exclusion Criteria:

  • Presence of another active malignant invasive neoplasm.
  • Pregnancy or lactation period.
  • Disease progression during treatment.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PARPi + Bev
Drug: PARP inhibitor + Bevacizumab
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel + bevacizumab (≥3 cycles) every 21 days. In case of a complete or partial response maintenance therapy is carried out until disease progression or intolerable toxicity or for 2 years to the regimen of PARP inhibitor + bevacizumab.
Experimental: PARPi
Drug: PARP inhibitor
Patients will receive 6 courses of chemotherapy according to the regimen of platinum drug + paclitaxel every 21 days. In case of a complete or partial response maintenance therapy of PARP inhibitor is carried out until disease progression or intolerable toxicity or for 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: From enrollment through study completion, an average of 2 year
Time from randomization to any sign or symptom of the cancer or death from the disease
From enrollment through study completion, an average of 2 year
The frequency of adverse events
Time Frame: From date of first immunotherapy dose through 60 months, or date of last patient contact
From date of first immunotherapy dose through 60 months, or date of last patient contact

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival 2
Time Frame: From the first recurrence through study completion, an average of 2 year
Time from the first recurrence when patient remains free of cancer signs or symptoms to any sign or symptom of the cancer or death from the disease
From the first recurrence through study completion, an average of 2 year
Time from Randomization to First Subsequent Therapy
Time Frame: From enrollment through study completion, an average of 2 year
Time from randomization to the initiation of the next (second-line) therapy, most often due to disease progression.
From enrollment through study completion, an average of 2 year
The quality of life
Time Frame: Through study completion, an average of 5 year
Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scales range from 0 to 100; higher scores indicate better outcomes on functional and global health scales, but worse outcomes on symptom scales
Through study completion, an average of 5 year

Collaborators and Investigators

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

Sponsor

N.N. Alexandrov National Cancer Centre

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)

July 1, 2025

Primary Completion (Estimated)

June 30, 2033

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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