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