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New treatment option for Ovarian Cancer Recurrent
Official title A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
ClinicalTrials.gov ID: NCT06843447
What this study is testing
What is Raludotatug Deruxtecan?
Raludotatug Deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer recurrent.
Also referred to as MK-5909, R-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6...
- Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression...
- Participants in Cohort B-1 and Cohort B-2: Is a candidate for bevacizumab treatment
You likely can't join if
- Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial...
- Has uncontrolled or significant cardiovascular disease
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary...
- 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...
See the full 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 Arms 2 and 3: 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...
- Participants in Cohort B-1 and Cohort B-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...
- Participants in Cohort B-1 and Cohort B-2: 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/randomization
- 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...
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants in Cohort C-1 and Cohort D: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie...
- Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie...
- Has any of the following within 6 months before allocation/randomization: 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...
- 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 any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Charlottesville, Virginia, United States
- Montreal, Quebec, Canada
- Haifa, Israel
- Jerusalem, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- L'Hospitalet de Llobregat, Barcelona, Spain
- Majadhonda, Madrid, Spain
- Madrid, Madrid, Comunidad de, Spain
- Valencia, Valenciana, Comunitat, Spain
- Barcelona, Spain
- Madrid, Spain
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States; New York, New York, United States; Oklahoma City, Oklahoma, United States; Fort Worth, Texas, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.