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)
Condition(s) studied
Investigational drug(s) / intervention(s)
R-DXd: R-DXd administered as an intravenously (IV) infusion
Bevacizumab: Administered as an intravenously IV infusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to approximately 4 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. - Overall Survival (OS) — Up to approximately 5.5 years
OS is defined as the time from randomization to death due to any cause.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| MedStar Washington Hospital Center ( Site 0026) | Washington D.C. | District of Columbia | Recruiting |
| Texas Oncology - DFW ( Site 8005) | Fort Worth | Texas | Recruiting |
| Rambam Health Care Campus ( Site 1402) | Haifa | Israel | Recruiting |
| Sourasky Medical Center ( Site 1403) | Tel Aviv | Israel | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07776691 on ClinicalTrials.gov ↗ ← All trials in Taiwan