Niraparib maintenance therapy for advanced ovarian cancer after chemotherapy

Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial

This study is testing if a drug called niraparib can help women with advanced ovarian cancer stay healthy longer after they respond to chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: bevacizumab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06141265 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of niraparib as a maintenance therapy for women with HRD-positive advanced epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers, who have responded to initial chemotherapy combined with bevacizumab. The study is a multicenter, open-label, single-arm phase II trial aiming to enroll 116 patients. Participants must have undergone primary tumor surgery and completed at least two cycles of bevacizumab with platinum-based chemotherapy, achieving a complete or partial response. The trial will assess the impact of niraparib on disease progression in this patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 or older with HRD-positive advanced epithelial ovarian cancer who have responded to front-line chemotherapy.

Not a fit: Patients with non-HRD-positive tumors or those who have not responded adequately to initial chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve progression-free survival for patients with advanced ovarian cancer.

How similar studies have performed: Previous studies have shown promising results for niraparib in similar patient populations, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. The written informed consent form shall be signed before proceeding with any study-related procedure.
2. Participants shall be a female, aged 18 years or older.
3. Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma。
4. FIGO staging is Stage III or IV.
5. Patients who have undergone primary tumor reductive surgery or intermittent tumor reductive surgery (patients who have used neoadjuvant therapy), regardless of postoperative residual lesion status
6. Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab in combination with platinum-based chemotherapy.
7. Participants must have completed front-line, platinum-based chemotherapy with CR, PR, or NED assessed by RECIST v1.1.
8. Participant must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase \> 15% from nadir).
9. Participants must have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy.
10. Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.
11. Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤2.
12. Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cell count ≥3×10\^9/L; Neutrophil count ≥1.5×10\^9/L; Platelet count ≥100×10\^9/L; Total bilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit; Serum creatinine is not more than 1.5 times the normal upper limit.

Exclusion Criteria:

1. Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer.
2. Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.
3. Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes, uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within the past 6 months, or other circulatory system diseases.
4. Any other significant complications or functional impairments in organ systems, as determined by the investigator, that may affect the safety of the participant or interfere with the evaluation of the investigational drug.
5. Expected survival less than 3 months.
6. Other than ovarian cancer, the participant has been diagnosed a second primary tumor within the past 2 years and currently undergoing treatment.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hong Zheng, M.D.

Conditions Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma