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Ovarian CancerCancerWomen's healthBiologicalDrugPhase 3

What this study is

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.

What's being tested

  • R-DXd

    Intervention · BIOLOGICAL

    R-DXd alone or in combination with bevacizumab administered via IV infusion

  • Bevacizumab

    Intervention · DRUG

    Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w

  • Carboplatin

    Intervention · 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

    Intervention · DRUG

    Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles

  • Gemcitabine

    Intervention · 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)

    Intervention · 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

Official title
A Phase 3, Open-Label, Multicenter, Randomized Study of Raludotatug Deruxtecan (MK-5909, R-DXd) With or Without Bevacizumab Versus Standard-of-Care Platinum-Based Doublet Chemotherapy With or Without Bevacizumab in Participants With Advanced Platinum-Sensitive High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Progressed During First-Line PARPi Maintenance (ENGOT-ov107 / GOG-3142 / REJOICE-Ovarian05)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Ovarian Cancer · Peritoneal Cancer · Fallopian Tube Cancer
Enrolling
646 people
Starts
2026-10-07
Est. completion
2031-08-31
Design
Single-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗