Study on Raludotatug Deruxtecan With or Without Bevacizumab for First-Line Maintenance in Advanced Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07776691

This clinical trial is exploring whether a new treatment, raludotatug deruxtecan, with or without bevacizumab, can help patients with advanced ovarian cancer live longer without the disease worsening compared to standard care.

Patient Parameters

Program Overview

This study is investigating a new approach to treating advanced ovarian cancer. After initial surgery and chemotherapy, patients often receive maintenance treatment to prevent the cancer from growing or returning. Bevacizumab is a common maintenance therapy that targets cancer cells. This study is testing a new drug, raludotatug deruxtecan (R-DXd), to see if it can help patients live longer without their cancer getting worse, either on its own or combined with bevacizumab, compared to the usual care options.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced ovarian cancer (Stage III or IV), fallopian tube cancer, or primary peritoneal cancer.
  • Have had surgery to remove as much of the cancer as possible.
  • Completed first-line platinum-based chemotherapy with stable disease, partial response, complete response, or no evidence of disease.
  • Provided tumor tissue that has not been treated with radiation.
  • Recovered from side effects of previous cancer treatments to a mild level or baseline, except for hair loss or skin changes.
  • If HIV-positive, must have well-controlled HIV on antiretroviral therapy.

Exclusion Criteria

  • Have a type of ovarian cancer that is not high-grade serous or endometrioid.
  • Have received first-line chemotherapy without bevacizumab and have stable or partially responding disease at screening.
  • Have had other systemic cancer treatments besides the required first-line chemotherapy.
  • Not fully recovered from major surgery or have ongoing surgical issues.
  • Have a tumor with a specific genetic feature (HRD-positive) or unknown status.
  • Have active inflammatory bowel disease needing medication or a history of it.
  • Have severe lung issues from other illnesses or past lung surgery.
  • Have a bowel obstruction or related issues due to ovarian cancer.
  • HIV-positive with a history of certain cancers like Kaposi's sarcoma.
  • Have another progressing cancer or one treated in the last 3 years.
  • Have an active infection needing treatment.

Locations

FACILITYZIPCITYSTATE
MedStar Washington Hospital Center ( Site 0026)20010Washington D.C.District of Columbia
Texas Oncology - DFW ( Site 8005)76104Fort WorthTexas

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