ClinicalTrials.gg
Not yet recruitingNCT07797283MAESTRA 3Updated Oct 2, 2026

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

A Phase 3 interventional study of INCB123667 and Bevacizumab in Ovarian Cancer, sponsored by Incyte Corporation. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment

Updated Oct 2, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
590
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Ovarian Neoplasms by Incyte Corporation — 3 open to participants now, 3 under way, 2 of them phase 3. Ovarian Neoplasms · Incyte Corporation.

Planned enrollment
Largest of 12
590 · median 143
Started
2026
the only one that year
Phase 3
2 of 12
2 open now
Registered
12th of 12
by date

Among the 12 studies in Ovarian Neoplasms by Incyte Corporation, this one has the largest planned enrollment, is the only one that started in 2026, is one of 2 in phase 3, and was the 12th registered.

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

3 of the 12 studies in Ovarian Neoplasms by Incyte Corporation are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Ovarian Neoplasms by Incyte Corporation, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Ovarian Cancer

Browse trials for

Keywords

  • INCB123667
04

Who can participate

The criteria were revised on the registry on Oct 2, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Newly diagnosed, 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 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 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.
  • performance status of 0, 1, or 2.

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 that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.
  • History of any 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 /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:

    • : \< 100 × 109/L
    • : \< 9 g/dL or \< 5.6 mmol/L
    • ANC: \< 1.5 × 109/L
    • : ≥ 2.5 × or ≥ 5 × ULN for participants with liver
    • AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
    • Total : ≥ 1.5 × ULN
    • Albumin: \< 2.5 g/dL
    • Calculated : \< 45 mL/min
    • Protein in urine: Urine dipstick for proteinuria ≥ 2+

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
590 participants (estimated)

Study arms

  • Experimental
    Treatment Group A (TGA)

    Bevacizumab plus INCB123667 at the protocol defined dose.

    Drug: INCB123667 · Drug: Bevacizumab

  • Experimental
    Treatment Group B (TGB)

    Bevacizumab plus matching placebo at the protocol defined dose.

    Drug: Bevacizumab · Drug: Placebo

Interventions

  • INCB123667 will be administered at the protocol defined dose.

  • Bevacizumab will be administered at the protocol defined dose.

  • DrugPlacebo

    Placebo will be administered at the protocol defined dose.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Defined as the time from randomization until death due to any cause.

    Time frame: Up to approximately 7 years

  2. 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.

    Time frame: Up to approximately 5 years

  3. 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.

    Time frame: Up to approximately 7 years

  4. 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.

    Time frame: Up to approximately 7 years

  5. 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.

    Time frame: Up to approximately 7 years

  6. 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.

    Time frame: Up to approximately 7 years

  7. 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.

    Time frame: Up to approximately 13 months

  8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment

    TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.

    Time frame: Up to approximately 13 months

  9. 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.

    Time frame: Up to approximately 5 years

  10. 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.

    Time frame: Up to approximately 5 years

  11. 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).

    Time frame: Up to approximately 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

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.

Data sharing details ↗ · www.incyte.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for May 2032, 65 months later.

Of 73 industry-sponsored phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 72. This study's planned 65 months is above that.

Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 1, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
May 1, 2032
CompletionEst.
May 1, 2034
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 criterion edited
What changed in the criteria
  • EditedECOG performance status of 0, 1, or 12.
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Eligibility 1 criterion edited
    What changed in the criteria
    • EditedECOG performance status of 0, 1, or 12.
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07797283
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
May 1, 2032 (estimated)
Completion
May 1, 2034 (estimated)
Last update
Oct 2, 2026

Study contacts

Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463
Incyte Corporation Call Center (ex-US)
Contact
eumedinfo@incyte.com
+800 00027423
Incyte Medical Monitor
study director · Incyte Corporation

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: CDK2 Inhibitor INCB123667

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