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NCT Number: NCT07472140

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancers Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

N.N. Alexandrov National Caner Centre

Minsk, Lesnoy, 223040, Belarus

Location status: Recruiting

Location contact

Hanna Trukhan

CONTACT

[email protected]

80291985715

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PARP inhibitor + Bevacizumab

Drug

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.

PARP inhibitor

Drug

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.

Primary outcomes

  1. 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

  2. The frequency of adverse events

    Time frame: From date of first immunotherapy dose through 60 months, or date of last patient contact

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Trukhan

CONTACT

[email protected]

80291985715

Sergey Mavrichev

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

N.N. Alexandrov National Cancer Centre

Other Gov

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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