A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

Last updated: April 25, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Ovarian Cysts

Treatment

Raludotatug Deruxtecan

Bevacizumab

Carboplatin

Clinical Study ID

NCT06843447
5909-003
MK-5909-003
U1111-1308-2821
2024-514674-47
  • Ages > 18
  • Female

Study Summary

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.

Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include:

  • Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing

  • Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread

Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with standard treatment and if people tolerate them together.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has pathologically documented diagnosis of high-grade serous epithelial ovariancancer, primary peritoneal cancer, or fallopian tube cancer

  • Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1

  • Participants in Cohort A-1 Arm 1 and Arm 2: Has relapsed disease after 1 to 3 priorlines of therapy and radiographic evidence of disease progression ≥6 months (≥180days) after the last dose of platinum-based therapy (ie, platinum-sensitivedisease).

  • Participants in Cohort B-1: Has relapsed disease after 1 to 3 prior lines of therapyand radiographic evidence of disease progression <6 months (<180 days) after thelast dose of platinum-based therapy (ie, platinum-resistant disease).

  • Participants in Cohort B-1: Is a candidate for bevacizumab treatment

  • Has provided tumor tissue from a core or excisional biopsy of a tumor lesion notpreviously irradiated

  • Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessedwithin 7 days before allocation

  • Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on anti-retroviral therapy

  • Participants who are hepatitis B surface antigen positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and haveundetectable HBV viral load prior to allocation

  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening

Exclusion

Exclusion Criteria:

  • Has any of the following within 6 months before allocation: cerebrovascularaccident, transient ischemic attack, or other arterial thromboembolic event

  • Has uncontrolled or significant cardiovascular disease

  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses including, but not limited to, any underlying pulmonary disorder, and anyautoimmune, connective tissue, or inflammatory disorders with potential pulmonaryinvolvement, or prior pneumonectomy

  • Has ≥Grade 2 peripheral neuropathy

  • Has received prior treatment with cadherin-6-targeted agents

  • Has received prior systemic anticancer therapy including investigational agentswithin 4 weeks or 5 half-lives (whichever is shorter) before allocation

  • Has received prior radiotherapy within 2 weeks of the start of study intervention,or has radiation-related toxicities, requiring corticosteroids

  • Receives chronic steroid treatment

  • Has known additional malignancy that is progressing or has required active treatmentwithin the past 3 years

  • Has known active CNS metastases and/or carcinomatous meningitis

  • Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) thatrequired steroids or has current pneumonitis/ILD

  • Has active infection requiring systemic therapy

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease

Study Design

Total Participants: 78
Treatment Group(s): 4
Primary Treatment: Raludotatug Deruxtecan
Phase: 1/2
Study Start date:
April 15, 2025
Estimated Completion Date:
March 27, 2029

Connect with a study center

  • Rambam Health Care Campus ( Site 0202)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 0201)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0200)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • START Mountain Region ( Site 0008)

    West Valley City, Utah 84119
    United States

    Active - Recruiting

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