Study on Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab for Ovarian Cancer That Has Progressed During First Line Maintenance Treatment
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07743164
This clinical trial is exploring a new treatment option for patients with advanced, high-grade ovarian cancer that has continued to grow despite initial maintenance therapy with PARP inhibitors. The study is testing the effectiveness of a drug called R-DXd, used alone or with another drug, bevacizumab, to see if it can help patients live longer and slow down cancer growth.
Patient Parameters
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Program Overview
Researchers are investigating new treatments for advanced ovarian cancer that has spread to other parts of the body and is difficult to remove with surgery. This study focuses on high-grade ovarian cancer, which grows and spreads quickly. The trial includes cancers that began in the ovaries, the lining of the abdomen, or the fallopian tubes.
Typically, treatment for this type of cancer may involve chemotherapy, which uses drugs to kill or stop cancer cells from growing, and bevacizumab, a targeted therapy that controls cancer cell growth and targets blood vessels feeding the tumor.
The trial aims to learn how well a new medicine, raludotatug deruxtecan (R-DXd), works when given alone or with bevacizumab. R-DXd is a special type of drug that targets cancer cells directly to destroy them. The study will compare how long patients live and how well their cancer is controlled with R-DXd, with or without bevacizumab, compared to standard treatments.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MemorialCare Orange Coast Medical Center ( Site 0032) | 92708 | Fountain Valley | California |
| Orlando Health Cancer Institute ( Site 0018) | 32806 | Orlando | Florida |
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