NCT06161025 · Daiichi Sankyo
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
What this study is about
This study will evaluate the safety and effectiveness of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
View original scientific description
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
Interventions
DRUG
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
DRUG
Paclitaxel
Paclitaxel will be administered as an IV infusion
DRUG
Topotecan
Topotecan will be administered as an IV infusion
DRUG
PLD
PLD will be administered as an IV infusion
Primary outcome measures
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)
Time frame: From date of randomization to data cut off, up to 18 months
The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.
Progression-free Survival (PFS) Based on BICR Assessment (Part B)
Time frame: From date of randomization to data cut off, up to 26 months
PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
- Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.
- Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
- Has received at least 1 but no more than 3 p
Where
- Anchorage, Alaska
- New Haven, Connecticut
- Coral Gables, Florida
- Deerfield Beach, Florida
- Lake Mary, Florida
- Miami, Florida
- Miami Beach, Florida
- Plantation, Florida
- Indianapolis, Indiana
- Edgewood, Kentucky
- Springfield, Massachusetts
- St Louis, Missouri
And 23 more locations — see the full list below.
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations