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

Description

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.

Conditions

Ovarian Cancer Recurrent

Study Overview

Study Details

Study overview

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.

A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

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

Condition
Ovarian Cancer Recurrent
Intervention / Treatment

-

Contacts and Locations

West Valley City

START Mountain Region ( Site 0008), West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, 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 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease).
  • * Participants in Cohort B-1: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \<6 months (\<180 days) after the last 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 not previously irradiated
  • * Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessed within 7 days before allocation
  • * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy
  • * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation
  • * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • * Has any of the following within 6 months before allocation: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
  • * 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, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, 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 agents within 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 treatment within the past 3 years
  • * Has known active CNS metastases and/or carcinomatous meningitis
  • * Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
  • * Has active infection requiring systemic therapy
  • * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-03-27