Study on Raludotatug Deruxtecan for Treating Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06843447

This clinical trial is exploring a new treatment called Raludotatug Deruxtecan (R-DXd) for people with high-grade serous ovarian cancer that has returned after treatment. The study aims to find out if R-DXd is safe and effective when used with standard treatments like chemotherapy and targeted therapy.

Patient Parameters

Program Overview

Researchers are testing a new treatment option for people with high-grade serous ovarian cancer that has come back after treatment. This type of cancer grows and spreads quickly and starts in the cells covering the ovaries, the lining of the belly, or the fallopian tubes. The usual treatments include chemotherapy, which uses medicine to kill cancer cells, and targeted therapy, which controls how cancer cells grow. Raludotatug Deruxtecan (R-DXd) is a new treatment being studied. It works by attaching to a protein on cancer cells and delivering medicine directly to them. The study will see if R-DXd is safe and can be used together with standard treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Have measurable cancer based on specific medical criteria.
  • For some participants: Cancer has returned after 1 to 3 previous treatments and has shown signs of growth at least 6 months after the last platinum-based treatment (platinum-sensitive).
  • For other participants: Cancer has returned after 1 to 3 previous treatments and has shown signs of growth less than 6 months after the last platinum-based treatment (platinum-resistant).
  • Eligible for treatment with bevacizumab.
  • Provided a tumor sample from a biopsy.
  • In good general health with a performance status score of 0 or 1.
  • If HIV-positive, must have well-controlled HIV with medication.
  • If hepatitis B positive, must have been treated for at least 4 weeks and have no detectable virus.
  • If previously infected with hepatitis C, must have no detectable virus at screening.

Exclusion Criteria

  • Had a stroke, mini-stroke, or other serious blood clot event in the past 6 months.
  • Have uncontrolled or serious heart disease.
  • Have severe lung problems from other illnesses or conditions.
  • Have significant nerve damage (Grade 2 or higher).
  • Have been treated with cadherin-6-targeted drugs before.
  • Have had cancer treatment, including experimental drugs, within 4 weeks or 5 half-lives before starting the study.
  • Have had radiation therapy within 2 weeks before starting the study or have side effects from radiation needing steroids.
  • Are on long-term steroid treatment.
  • Have another active cancer that is growing or needed treatment in the past 3 years.
  • Have active cancer spread to the brain or spinal cord.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • If HIV-positive, have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.

Locations

FACILITYZIPCITYSTATE
START Mountain Region ( Site 0008)84119West Valley CityUtah

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