Raludotatug Deruxtecan With or Without Bevacizumab as First‑Line Maintenance in Advanced Ovarian 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 phase 3 study evaluates raludotatug deruxtecan as maintenance therapy after initial debulking surgery and platinum-based chemotherapy for high-risk epithelial ovarian cancer and related peritoneal cancers. Participants are assigned to receive either raludotatug deruxtecan alone or with bevacizumab, or standard maintenance care, to see which approach best prolongs progression-free survival. The trial includes patients who have undergone surgery and responded to platinum therapy, and requires tumor samples not previously irradiated. Key safety monitoring will track treatment-related adverse events and recovery from any prior toxicities. Enrollment is limited to sites in the United States where experienced ovarian cancer teams can manage targeted therapy regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer
* Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)
* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol
* Has provided tumor tissue that is not previously irradiated
* Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator
* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and undifferentiated carcinoma
* Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening
* Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
* Has not recovered from major surgery or has ongoing surgical complications
* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy
* Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam
* HIV-infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has active infection requiring systemic therapy

Where it's running

• MedStar Washington Hospital Center ( Site 0026)
  Washington D.C., District of Columbia, United States Recruiting
• Lahey Hospital & Medical Center ( Site 0031)
  Burlington, Massachusetts, United States Recruiting
• Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
  Eugene, Oregon, United States Recruiting
• Texas Oncology - West Texas ( Site 8009)
  Amarillo, Texas, United States Recruiting
• Texas Oncology - Central/South Texas ( Site 8002)
  Austin, Texas, United States Recruiting
• Texas Oncology - DFW ( Site 8005)
  Fort Worth, Texas, United States 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.

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

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• Comparing Niraparib alone versus Niraparib with Bevacizumab for advanced ovarian cancer treatment

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• Sac-TMT maintenance for people with non-HRD advanced ovarian cancer

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• Personalized timing of interval debulking surgery for advanced ovarian, fallopian tube, and peritoneal cancer.

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  Recruiting Phase 2 The University of Hong Kong · Hong Kong · NCT07022535

• Evaluating a new treatment for recurrent ovarian cancer

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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.