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

Sponsor
Incyte Corporation
Study ID
NCT07797283
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB123667 — DRUG
    INCB123667 will be administered at the protocol defined dose.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at the protocol defined dose.
  • Placebo — DRUG
    Placebo will be administered at the protocol defined dose.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
May 1, 2032
Completion
May 1, 2034

Study Design

Enrollment
590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A (TGA)
    Bevacizumab plus INCB123667 at the protocol defined dose.
  • Experimental: Treatment Group B (TGB)
    Bevacizumab plus matching placebo at the protocol defined dose.

Primary Outcome Measure

Progression-Free Survival (PFS) by BICR [ Time Frame: Up to approximately 5 years ]

Central Contacts

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