A Phase 3 interventional study of R-DXd and Bevacizumab in Ovarian Cancer, Peritoneal Cancer and Fallopian Tube Cancer, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.
The usual treatment for high-grade OC may include one or both of these:
Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 646 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
The main exclusion criteria include but are not limited to the following:
Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd) with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation
Biological: R-DXd · Drug: Bevacizumab
Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab. Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation
Drug: Bevacizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Gemcitabine · Drug: Pegylated liposomal doxorubicin (PLD)
R-DXd alone or in combination with bevacizumab administered via IV infusion
Also known as: raludotatug deruxtecan, MK-5909, DS-6000a
Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
Also known as: AVASTIN®, MVASI®
Carboplatin area under the curve (AUC) 5 mg/mL\*min or AUC 4 mg/mL\*min administered on day 1 q3w for a maximum of 8 cycles
Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles
Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles
PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered disease progression. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 4 years
Number of Participants who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 3 years
Number of Participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 3 years
Duration of Response (DOR)
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, disease progression (DP) is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered DP.
Time frame: Up to approximately 3 years
Progression-free Survival 2 (PFS2)
PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
Time to First Subsequent Anticancer Treatment (TFST)
TFST is defined as the time from randomization to initiation of first subsequent anticancer treatment or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire 30- (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Time frame: Baseline and at designated time points up to approximately 3 years
Change from Baseline in EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28) Abdominal/Gastrointestinal (GI) Scale
EORTC QLQ-OV28 is an ovarian cancer-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
Time frame: Baseline and at designated time points up to approximately 3 years
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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