Can a new drug extend remission in advanced ovarian cancer?

NCT ID NCT07797283

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests whether adding an experimental drug called INCB123667 to the standard maintenance therapy bevacizumab can delay cancer recurrence in people with advanced ovarian, fallopian tube, or primary peritoneal cancer. Participants must have completed initial chemotherapy and surgery. The study compares the combination against bevacizumab alone, measuring how long people live without their cancer progressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INCB123667 combined with bevacizumab
What this could lead to
If it works, this combination could delay cancer recurrence and extend survival for people with advanced ovarian cancer who have finished initial chemotherapy.
What could go wrong
This is a phase 3 trial, but the drug is still experimental. It may not improve outcomes, and adding it could increase side effects compared to bevacizumab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Contacts and locations

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