A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07743164
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 alone or in combination with bevacizumab administered via IV infusion
  • Bevacizumab — DRUG
    Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
  • Carboplatin — DRUG
    Carboplatin area under the curve (AUC) 5 mg/mL\*min or AUC 4 mg/mL\*min administered on day 1 q3w for a maximum of 8 cycles
  • Paclitaxel — DRUG
    Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles
  • Pegylated liposomal doxorubicin (PLD) — DRUG
    PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles

Study Details

Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes. The usual treatment for high-grade OC may include one or both of these: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing. * Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels. Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells. The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.

Key Dates

First listed
Aug 3, 2026
Start date
Oct 5, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

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

Arms

  • Experimental: R-DXd +/- 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: Standard of Care
    Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab. Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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