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Not Yet Recruiting NCT07797283

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

Conditions: Ovarian Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 590
Sponsor: Incyte Corporation

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07797283). StuddyBuddy aggregates publicly available trial information.