Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| INCB123667 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group A (TGA)
- description
- Bevacizumab plus INCB123667 at the protocol defined dose.
- interventionNames
- Drug: INCB123667
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Treatment Group B (TGB)
- description
- Bevacizumab plus matching placebo at the protocol defined dose.
- interventionNames
- Drug: Bevacizumab
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) by BICR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available