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

Korábbi kezelés

• Eligible for treatment with a PARPi as maintenance therapy.
• History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization.
• 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.

Más betegség

• Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer.
• Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.

Laborértékek

• 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.

Egyéb

• Deleterious tumor BRCA mutation per local test.
• Clinically significant gastrointestinal abnormality.

• 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, 1, or 2.