Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)

Bevacizumab plus INCB123667 at the protocol defined dose.

INCB123667 will be administered at the protocol defined dose.

Bevacizumab will be administered at the protocol defined dose.

Bevacizumab plus matching placebo at the protocol defined dose.

Bevacizumab will be administered at the protocol defined dose.

Placebo will be administered at the protocol defined dose.

Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.

Defined as the time from randomization until death due to any cause.

Defined as the time from randomization until the first documented disease progression or disease recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

Defined as the time from randomization until radiologic or clinical disease progression on the first subsequent therapy as assessed by the investigator, or death due to any cause, whichever occurs first.

Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator.

Defined as the time from randomization until the start of the first subsequent therapy, or death due to any cause, whichever occurs first.

Defined as the time from randomization until the start of the second subsequent therapy, or death due to any cause, whichever occurs first.

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.

TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.

The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in patients with cancer. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.

The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer. It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss.

The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).