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

A Phase 3, Double-Blind, Randomized, Controlled Study of 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 (MAESTRA 3)

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.

Inclusion Criteria:

• 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.
  • Received at least 2 infusions of bevacizumab concurrently with the last 2 to 3 cycles of chemotherapy.

• No clinical evidence of disease recurrence (ie, NED following surgery) or progression (ie, CR/PR/SD per RECIST v1.1) on completion of platinum-based chemotherapy.

• Tumor overexpresses cyclin E1.

• Has a local HRD (positive or negative) or BRCA test result available. Participants with BRCA wild-type must have a local HRD result based on a validated test.

• ECOG performance status of 0 or 1.

Exclusion Criteria:

• 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.

• History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization.

• Clinically significant gastrointestinal abnormality.

• History of thromboembolism and having been on therapeutic anticoagulation for less than 2 weeks prior to randomization.

• Current treatment with any strong CYP3A4/CYP3A5 inhibitor or inducer or treatment with a strong CYP3A4/CYP3A5 inhibitor or inducer within 5 half-lives or 28 days (whichever is shorter) prior to randomization.

• Exclusionary Laboratory Values:

  • Platelets: < 100 × 109/L
  • Hemoglobin: < 9 g/dL or < 5.6 mmol/L
  • ANC: < 1.5 × 109/L
  • ALT: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
  • AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
  • Total bilirubin: ≥ 1.5 × ULN
  • Albumin: < 2.5 g/dL
  • Calculated CrCl: < 45 mL/min
  • Protein in urine: Urine dipstick for proteinuria ≥ 2+

Other protocol-defined Inclusion/Exclusion Criteria may apply.