Sacituzumab Tirumotecan With or Without Bevacizumab Versus Standard of Care in Patients With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following Platinum-Based Chemotherapy

The primary objective of this study is to compare the efficacy of sacituzumab tirumotecan maintenance treatment, with or without bevacizumab, against the standard of care in patients with newly diagnosed advanced homologous recombination deficiency-negative ovarian cancer following first-line platinum-based chemotherapy. The evaluation focuses on progression-free survival as determined by RECIST 1.1 through independent central review. Secondary objectives include:

• Comparison of overall survival between the study arms and standard of care.
• Evaluation of progression-free survival 2 as assessed by the investigator.
• Assessment of the safety and tolerability of the maintenance regimens.
• Measurement of changes in health-related quality of life and abdominal/gastrointestinal symptoms using standardized EORTC questionnaires.

The study involves 597 female participants diagnosed with ovarian cancer, including primary peritoneal or fallopian tube cancer. The cohort consists of individuals with histologically confirmed FIGO Stage III or Stage IV disease who have undergone primary debulking surgery or interval debulking surgery. Eligible participants must have completed first-line platinum-based chemotherapy with a documented response of stable disease, partial response, or complete response. Requirements for participation include the provision of non-irradiated tumor tissue and the management of specific viral statuses, such as well-controlled human immunodeficiency virus or undetectable hepatitis B virus and hepatitis C virus viral loads. The age range for this population corresponds to specific clinical classifications.

This Phase 3, randomized, open-label, multicenter study is designed to evaluate the efficacy and safety of sacituzumab tirumotecan maintenance treatment, either alone or in combination with bevacizumab, compared to the standard of care. The study focuses on participants diagnosed with advanced HRD-negative ovarian cancer who have completed first-line platinum-based chemotherapy. The primary endpoint is progression-free survival as assessed by blinded independent central review. Secondary endpoints include overall survival, second progression-free survival, and various measures of quality of life and safety, such as the frequency of adverse events. The trial is estimated to be active through April 2033.

Sacituzumab tirumotecan (MK-2870) is an experimental medication administered as a solution for injection. The treatment is delivered via intravenous infusion at a dosage of 4 mg/kg.

Bevacizumab, provided as either Avastin or MVASI in the form of a solution for infusion, is utilized in this study. This substance is administered through intravenous infusion at a dose of 15 mg/kg.

The primary efficacy endpoint is progression-free survival (PFS), which is evaluated according to RECIST 1.1 and assessed by blinded independent central review (BICR). Secondary endpoints include overall survival (OS), second progression-free survival (PFS2), and the frequency of adverse events (AE) or treatment discontinuation due to an AE.

Patient-reported outcomes are utilized to assess changes from baseline in the following parameters:

• Global Health Status/Quality of Life (GHS/QoL) combined score, measured using the EORTC QLQ-C30 questionnaire.
• Physical Functioning combined score, measured using the EORTC QLQ-C30.
• Role Functioning combined score, measured using the EORTC QLQ-C30.
• Abdominal/Gastrointestinal (GI) symptoms combined score, measured using the EORTC QLQ-Ovarian Cancer Module 28 (OV28).