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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: INCB123667; Drug: Bevacizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 590
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group A (TGA); Bevacizumab plus INCB123667 at the protocol defined dose.	Drug: INCB123667; INCB123667 will be administered at the protocol defined dose.; Drug: Bevacizumab; Bevacizumab will be administered at the protocol defined dose.
Experimental: Treatment Group B (TGB); Bevacizumab plus matching placebo at the protocol defined dose.	Drug: Bevacizumab; Bevacizumab will be administered at the protocol defined dose.; Drug: Placebo; Placebo will be administered at the protocol defined dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) by BICR	Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time from randomization until death due to any cause.	Up to approximately 7 years
Progression-Free Survival (PFS) by investigator	Defined as the time from randomization until the first documented disease progression or disease recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause, whichever occurs first.	Up to approximately 5 years
Progression-Free Survival on the First Subsequent Therapy (PFS2)	Defined as the time from randomization until radiologic or clinical disease progression on the first subsequent therapy as assessed by the investigator, or death due to any cause, whichever occurs first.	Up to approximately 7 years
Second Progression-Free Survival (PFS)	Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator.	Up to approximately 7 years
Time to First Subsequent Therapy (TFST)	Defined as the time from randomization until the start of the first subsequent therapy, or death due to any cause, whichever occurs first.	Up to approximately 7 years
Time to Second Subsequent Therapy (TSST)	Defined as the time from randomization until the start of the second subsequent therapy, or death due to any cause, whichever occurs first.	Up to approximately 7 years
Treatment Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.	Up to approximately 13 months
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment	TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.	Up to approximately 13 months
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit	The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in patients with cancer. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.	Up to approximately 5 years
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -Ovarian Cancer 28 (OV28) score at each postbaseline visit	The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer. It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss.	Up to approximately 5 years
Change from baseline in EQ-5D-5L score at each postbaseline visit	The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: INCB123667
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab
• Other Study ID Numbers: INCB123667-302; 2026-526071-30-00 (Registry Identifier: EU CT Number); ENGOT-OV106 (Other Identifier: ENGOT Study Number); GOG-3146 (Other Identifier: GOG Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No