Ovarian CancerPhase 3MAESTRA 3NCT07797283
Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1
A Phase 3 study testing INCB123667 and Bevacizumab in people with Ovarian Cancer, run by Incyte Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- INCB123667 and Bevacizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 May 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Ovarian Cancer
- Being tested
- INCB123667, Bevacizumab, Placebo
- Keywords
- INCB123667
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB123667Drug
INCB123667 will be administered at the protocol defined dose.
BevacizumabDrug
Bevacizumab will be administered at the protocol defined dose.
PlaceboDrug
Placebo will be administered at the protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A (TGA) | Experimental | Bevacizumab plus INCB123667 at the protocol defined dose. Receives: Drug: INCB123667; Drug: Bevacizumab |
| Treatment Group B (TGB) | Experimental | Bevacizumab plus matching placebo at the protocol defined dose. Receives: Drug: Bevacizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 5 years
Secondary outcomes (11)
Overall Survival (OS)
Defined as the time from randomization until death due to any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 May 2032 (estimated)
- Study completion1 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797283
- Sponsor's protocol ID
- INCB123667-302
- Other IDs
- 2026-526071-30-00, ENGOT-OV106, GOG-3146
- Acronym
- MAESTRA 3
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07797283
- Acronym / sponsor ID
- MAESTRA 3 / INCB123667-302
- Conditions
- Ovarian Cancer
- Keywords
- INCB123667
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 May 2032 (estimated)
- Study completion
- 1 May 2034 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A (TGA) | Experimental | Drug: INCB123667, Drug: BevacizumabBevacizumab plus INCB123667 at the protocol defined dose. |
| Treatment Group B (TGB) | Experimental | Drug: Bevacizumab, Drug: PlaceboBevacizumab plus matching placebo at the protocol defined dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB123667INCB123667 will be administered at the protocol defined dose. | Drug | Treatment Group A (TGA) |
| BevacizumabBevacizumab will be administered at the protocol defined dose. | Drug | Treatment Group A (TGA), Treatment Group B (TGB) |
| PlaceboPlacebo will be administered at the protocol defined dose. | Drug | Treatment Group B (TGB) |
Primary outcome
Progression-Free Survival (PFS) by BICR
Time frame: Up to approximately 5 years
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.
11 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 7 years
Progression-Free Survival (PFS) by investigator
Time frame: Up to approximately 5 years
Progression-Free Survival on the First Subsequent Therapy (PFS2)
Time frame: Up to approximately 7 years
Second Progression-Free Survival (PFS)
Time frame: Up to approximately 7 years
Time to First Subsequent Therapy (TFST)
Time frame: Up to approximately 7 years
Time to Second Subsequent Therapy (TSST)
Time frame: Up to approximately 7 years
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 13 months
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time frame: 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
Time frame: 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
Time frame: Up to approximately 5 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INCB123667 and Bevacizumab in people with Ovarian Cancer, run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by BICR (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.