NCT07743164RecruitingPhase 3
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)
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)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 646 (estimated)
- First submitted
- 29 Jul 2026
- Start date
- 7 Oct 2026
- Primary completion date
- 31 Aug 2031
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ovarian cancer
- NCT number
- NCT07743164
- EU CT number
- 2025-525130-59-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 646
- From 7 Oct 2026 to the primary completion date, 31 Aug 2031
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- The main inclusion criteria include but are not limited to the following:
- Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Has received 1 line of platinum-based therapy with a minimum of 4 cycles of platinum-doublet chemotherapy and have platinum-sensitive disease.
- Has received a poly (ADP-ribose) polymerase inhibitor (PARPi) as maintenance treatment after the first line platinum-based chemotherapy course and experienced radiographic progression during treatment or within 42 days of the last dose of PARPi.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization.
- Has recovered from any AEs due to previous anticancer therapies.
- The main exclusion criteria include but are not limited to the following:
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer.
- Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active GI bleeding within 6 months before randomization.
- Has uncontrolled or significant cardiovascular disease.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.
- Has received chronic steroid treatment, with some exceptions.
- Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial ovarian cancer, abdominal fistula or GI perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah Medical Center (Site 2700) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sourasky Medical Center (Site 2701) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| National Cheng Kung University Hospital (Site 5304) Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| JPS Oncology and Infusion Center (Site 0019) Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| MemorialCare Orange Coast Medical Center (Site 0032) Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Orlando Health Cancer Institute (Site 0018) Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.