Ovarian CancerPhase 3NCT07776691
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
A Phase 3 study testing R-DXd and Bevacizumab in people with Ovarian Cancer and Ovarian Neoplasms, run by Merck Sharp & Dohme LLC at 7 sites in 4 countries.
Trial summary
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Peritoneal Cancer
- What is being tested?
- R-DXd and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 18 Sep 2026to 22 Oct 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer
- Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)
- Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol
- Has provided tumor tissue that is not previously irradiated
- Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and undifferentiated carcinoma
- Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening
- Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
- Has not recovered from major surgery or has ongoing surgical complications
- Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
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- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy
- Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam
- HIV-infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active infection requiring systemic therapy
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United States3 sites, 3 recruiting
- Recruiting
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, 76104
Study Coordinator, 817-413-1500
- Recruiting
Texas Oncology - Northeast Texas ( Site 8004)
Tyler, Texas, 75702
Study Coordinator, 903-535-4688
- Recruiting
MedStar Washington Hospital Center ( Site 0026)
Washington D.C., District of Columbia, 20010
Study Coordinator, 202-877-9386
Israel2 sites, 2 recruiting
- Recruiting
Rambam Health Care Campus ( Site 1402)
Haifa, 3109601
Study Coordinator, +97247772688
- Recruiting
Sourasky Medical Center ( Site 1403)
Tel Aviv, 6423906
Study Coordinator, 03-6973494
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center ( Site 2303)
Seoul, 06351
Study Coordinator, +82-2-3410-1382
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital ( Site 2601)
Tainan, 704
Study Coordinator, +88662353535
About this study
Official title: A Phase 3, Randomized, Open-label Study of Raludotatug Deruxtecan (MK-5909, R-DXd) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly-Diagnosed Advanced Non-HRD-Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (ENGOT-ov102/MITO/GOG-3141/ REJOICE-Ovarian 04)
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
- Being tested
- R-DXd, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-DXdBiological
R-DXd administered as an intravenously (IV) infusion
BevacizumabDrug
Also called Avastin®, MVASI®, Altuzan®
Administered as an intravenously IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: R-DXd with or without bevacizumab | Experimental | 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. Receives: Biological: R-DXd; Drug: Bevacizumab |
| Arm 2: Standard of care (bevacizumab or observation only) | Active comparator | Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD 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 have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Measured: Up to approximately 4 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5.5 years
Secondary outcomes (5)
Progression-Free Survival 2 (PFS2)
PFS2 as assessed by investigator is defined from time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first
Measured: Up to approximately 5.5 years
Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Score (Item 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
The 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 score will be presented.
Measured: Baseline and up to approximately 4 years
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)
EORTC QLQ-OV28 is an OC-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.
Measured: Baseline and up to approximately 4 years
Number of Participants who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 4 years
Number of Participants who Discontinue Study Treatment due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start18 Sep 2026
- Primary completion19 Mar 2032 (estimated)
- Study completion22 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776691
- Sponsor's protocol ID
- 5909-006
- Other IDs
- U1111-1331-2704, 2025-524592-22-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf