Raludotatug Deruxtecan with or without Bevacizumab for advanced ovarian, peritoneal, or fallopian tube cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating R-DXd, an antibody-drug conjugate, given with or without bevacizumab, in patients with advanced high-grade ovarian or related cancers who progressed on PARP-inhibitor maintenance after platinum therapy. Participants may also receive standard chemotherapy agents such as carboplatin, paclitaxel, or gemcitabine as part of treatment regimens. The study aims to determine whether adding R-DXd improves outcomes compared with regimens without it. Eligibility includes high-grade serous or endometrioid histology, platinum-sensitive disease, and adequate recovery from prior therapies. Exclusions include certain non-target histologies and specific prior treatment considerations.

Why it matters

Who can join: the full rules

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.

Where it's running

• MemorialCare Orange Coast Medical Center ( Site 0032)
  Fountain Valley, California, United States Recruiting
• Orlando Health Cancer Institute ( Site 0018)
  Orlando, Florida, United States Recruiting
• Lahey Clinic ( Site 0042)
  Burlington, Massachusetts, United States Recruiting
• JPS Oncology and Infusion Center ( Site 0019)
  Fort Worth, Texas, United States Recruiting
• Hadassah Medical Center ( Site 2700)
  Jerusalem, Israel Recruiting
• Sourasky Medical Center ( Site 2701)
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.