Second Look Laparoscopy for Disease Evaluation in Patients Who Have Completed Initial Chemotherapy for Advanced Ovarian Cancer

PRIMARY OBJECTIVE:

I. To evaluate the safety and feasibility of SLL in patients completing first-line therapy for advanced ovarian cancer.

SECONDARY OBJECTIVES:

I. To describe the progression free survival (PFS) and PFS at 12 months (PFS 12) for patients with homologous recombination deficient (HRD) or homologous recombination proficient (HRP) ovarian cancer and minimal residual disease (MRD) determined at time of SLL versus (vs) no MRD determined at time of SLL, treated in the front-line/maintenance.

II. To describe overall survival for all patients and for patients with or without MRD identified at time of SLL.

EXPLORATORY OBJECTIVES:

I. Development of organoids, generated from biopsies performed at progression of disease, to inform future planned interventional arms for those patients with resistant disease.

II. Association of MRD detected by SLL with other detection methods including ca-125 levels and circulating cell-free deoxyribonucleic acid (cfDNA) levels, and their association with PFS/overall survival (OS).

III. Description of PFS and OS for Longitudinal and Safety Analysis Dataset patient populations.

OUTLINE:

Within 12 weeks of completion of initial standard of care chemotherapy, patients undergo second look laparoscopy with biopsy. Patients then receive standard of care maintenance therapy or observation per their treating physician. Patients also undergo blood sample collection throughout the study and undergo computed tomography (CT) on study and during follow up.

After completion of the study intervention, patients are followed up every 3 months for the first 24 months, every 6 months for the next 36 months and then yearly thereafter.