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

NCT07797283 | Not Yet Recruiting Phase 3 FDA Drug

• 4 other identifiers: INCB123667-3022026-526071-30-00ENGOT-OV106GOG-3146
• Study Type: interventional
• Target: 590
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer

Keywords

INCB123667

Outcome Measures

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.

  Up to approximately 5 years

Secondary Outcomes (11)

• Overall Survival (OS)

  Up to approximately 7 years

• Progression-Free Survival (PFS) by investigator

  Up to approximately 5 years

• Progression-Free Survival on the First Subsequent Therapy (PFS2)

  Up to approximately 7 years

• Second Progression-Free Survival (PFS)

  Up to approximately 7 years

• Time to First Subsequent Therapy (TFST)

  Up to approximately 7 years

Study Arms (2)

Treatment Group A (TGA)

EXPERIMENTAL

Bevacizumab plus INCB123667 at the protocol defined dose.

Drug: INCB123667; Drug: Bevacizumab

Treatment Group B (TGB)

EXPERIMENTAL

Bevacizumab plus matching placebo at the protocol defined dose.

Drug: Bevacizumab; Drug: Placebo

Interventions

INCB123667 DRUG

INCB123667 will be administered at the protocol defined dose.

Treatment Group A (TGA)

Bevacizumab DRUG

Bevacizumab will be administered at the protocol defined dose.

Treatment Group A (TGA); Treatment Group B (TGB)

Placebo DRUG

Placebo will be administered at the protocol defined dose.

Treatment Group B (TGB)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 1, or 2.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Related Links

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

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2034
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.