NCT07472140

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
85mo left

Started Jul 2025

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jul 2025Jun 2033

Study Start

First participant enrolled

July 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2033

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

8 years

First QC Date

March 2, 2026

Last Update Submit

March 11, 2026

Conditions

Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

  • Disease-free survival

    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

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

Secondary Outcomes (3)

  • Disease-free survival 2

    From the first recurrence through study completion, an average of 2 year

  • Time from Randomization to First Subsequent Therapy

    From enrollment through study completion, an average of 2 year

  • The quality of life

    Through study completion, an average of 5 year

Study Arms (2)

PARPi + Bev

EXPERIMENTAL
Drug: PARP inhibitor + Bevacizumab

PARPi

EXPERIMENTAL
Drug: PARP inhibitor

Interventions

PARP inhibitor + BevacizumabDRUG

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.

PARPi + Bev
PARP inhibitorDRUG

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.

PARPi

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.N. Alexandrov National Caner Centre

Minsk, Lesnoy, 223040, Belarus

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Poly(ADP-ribose) Polymerase InhibitorsBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic UsesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Hanna Trukhan

CONTACT

80291985715annavladimir@rambler.ru

Sergey Mavrichev

CONTACT

smavrichev71@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 16, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2033

Study Completion (Estimated)

June 30, 2033

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

BE(1)