drugset / Trial / NCT07743164

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)

NCT07743164 ↗

Phase 3 Not yet recruiting 646 enrolled Merck Sharp & Dohme LLC Daiichi Sankyo · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2026-10-05
Primary completion
2031-08-31
Completion
2031-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Comparator Carboplatin Small molecule 4 unknown —
Comparator Carboplatin Small molecule 5 unknown —
Comparator Gemcitabine Small molecule 1000 mg/ml Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Comparator Pegylated liposomal doxorubicin (PLD) Unknown 30 mg/m2 Intravenous
Subject R-DXd Unknown — Intravenous