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)
Condition(s) studied
Investigational drug(s) / intervention(s)
R-DXd: R-DXd alone or in combination with bevacizumab administered via IV infusion
Bevacizumab: Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
Carboplatin: 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: Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles
Gemcitabine: 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): PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to approximately 3 years
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Disease progression 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 demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered disease progression. PFS as assessed by blinded independent central review (BICR) will be presented. - Overall Survival (OS) — Up to approximately 4 years
OS is defined as the time from randomization to death due to any cause.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| MemorialCare Orange Coast Medical Center ( Site 0032) | Fountain Valley | California | Recruiting |
| Orlando Health Cancer Institute ( Site 0018) | Orlando | Florida | Recruiting |
| Sourasky Medical Center ( Site 2701) | Tel Aviv | Israel | Recruiting |
| National Cheng Kung University Hospital ( Site 5304) | Tainan | Taiwan | 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 NCT07743164 on ClinicalTrials.gov ↗ ← All trials in the USA