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

N.N. Alexandrov National Cancer Centre

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Fallopian Tube Cancers; Primary Peritoneal Cancer; Ovarian Cancer

Treatments: Drug: PARP inhibitor + Bevacizumab; Drug: PARP inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07472140

20260012

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

PARPi + Bev

Experimental group

Treatment:

Drug: PARP inhibitor + Bevacizumab

PARPi

Experimental group

Treatment:

Drug: PARP inhibitor