A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07776691
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

  • R-DXd — BIOLOGICAL
    R-DXd administered as an intravenously (IV) infusion
  • Bevacizumab — DRUG
    Administered as an intravenously IV infusion

Study Details

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Key Dates

First listed
Aug 20, 2026
Start date
Sep 22, 2026
Status verified
Aug 2026
Primary completion
Mar 19, 2032
Completion
Oct 22, 2034

Study Design

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

Arms

  • Experimental: Arm 1: R-DXd with or without bevacizumab
    Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd)with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation.
  • Active Comparator: Arm 2: Standard of care (bevacizumab or observation only)
    Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]

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