The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.
Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer.
Underwent debulking surgery prior to randomization (either PDS or IDS).
Completed first-line platinum-based chemotherapy in combination with bevacizumab prior to randomization.
Received a minimum of 6 cycles (and no more than 8 cycles) of platinum-taxane chemotherapy.
Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer.
Deleterious tumor BRCA mutation per local test.
Eligible for treatment with a PARPi as maintenance therapy.
Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.
Parallel
INCB123667
DrugINCB123667 will be administered at the protocol defined dose.
Bevacizumab
DrugBevacizumab will be administered at the protocol defined dose.
Placebo
DrugPlacebo will be administered at the protocol defined dose.
Progression-Free Survival (PFS) by BICR
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.
Overall Survival (OS)
Defined as the time from randomization until death due to any cause.
Progression-Free Survival (PFS) by investigator
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.
Progression-Free Survival on the First Subsequent Therapy (PFS2)
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.
Second Progression-Free Survival (PFS)
Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator.
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