ClinicalTrials.gg
RecruitingNCT07776691Updated Nov 5, 2026

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 interventional study of R-DXd and Bevacizumab in Ovarian Cancer, Ovarian Neoplasms and Peritoneal Cancer, sponsored by Merck Sharp & Dohme LLC. Recruiting at 13 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 5, 2026First sites in South Korea, Taiwan and United Kingdom10 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
802
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Ovarian Neoplasms by Merck Sharp & Dohme LLC — 6 open to participants now, 7 under way, 5 of them phase 3. Ovarian Neoplasms · Merck Sharp & Dohme LLC.

Planned enrollment
3rd of 21
802 · median 160
Started
2026
with 3 others
Phase 3
6 of 23
4 open now
Registered
22nd of 23
by date

Among the 23 studies in Ovarian Neoplasms by Merck Sharp & Dohme LLC, this one is the 3rd largest by planned enrollment of the 21 interventional ones, is one of 4 that started in 2026, is one of 6 in phase 3, and was the 22nd registered.

By phase

23 studies; the count open now beside each. This study's row is marked.

Phase 26 · 0 open
Phase 3this study6 · 4 open
Phase 15 · 1 open
Observational2 · 0 open
Phase 1/22 · 1 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 1999; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 160 across the 21 interventional studies, 189 across the 2 observational. Of the 16 that completed or were terminated, 10 (63%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 23 studies in Ovarian Neoplasms by Merck Sharp & Dohme LLC, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Ovarian Cancer
  • Ovarian Neoplasms
  • Peritoneal Cancer
  • Fallopian Tube Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has a new, 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 (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
  • (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)

Exclusion criteria

Exclusion Criteria:

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 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
  • Has active inflammatory bowel disease requiring 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, bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam
  • -infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease
  • Has known additional that is progressing or has required active treatment within the past 3 years
  • Has active infection requiring systemic therapy
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
802 participants (estimated)

Study arms

  • Experimental
    Arm 1: R-DXd with or without bevacizumab

    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

  • Active comparator
    Arm 2: Standard of care (bevacizumab or observation only)

    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.

    Drug: Bevacizumab

Interventions

  • BiologicalR-DXd

    R-DXd administered as an intravenously (IV) infusion

  • Administered as an intravenously IV infusion

    Also known as: Avastin®, MVASI®, Altuzan®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 4 years

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Time frame: Up to approximately 5.5 years

Secondary outcomes

  1. 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

    Time frame: Up to approximately 5.5 years

  2. 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.

    Time frame: Baseline and up to approximately 4 years

  3. 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.

    Time frame: Baseline and up to approximately 4 years

  4. 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.

    Time frame: Up to approximately 4 years

  5. 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.

    Time frame: Up to approximately 4 years

07

Study locations

13 of 13 sites recruiting
  • MedStar Washington Hospital Center ( Site 0026)
    Washington D.C., District of Columbia 20010, United States
    Recruiting
    • Study Coordinator · Contact202-877-9386
  • Lahey Hospital & Medical Center ( Site 0031)
    Burlington, Massachusetts 01805, United States
    Recruiting
    • Study Coordinator · Contact781-744-3421
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
    Eugene, Oregon 97401, United States
    Recruiting
    • Study Coordinator · Contact541-683-5001
  • Texas Oncology - West Texas ( Site 8009)
    Amarillo, Texas 79124, United States
    Recruiting
    • Study Coordinator · Contact325-692-0188
  • Texas Oncology - Central/South Texas ( Site 8002)
    Austin, Texas 78731, United States
    Recruiting
    • Study Coordinator · Contact512-427-9400
  • Texas Oncology - DFW ( Site 8005)
    Fort Worth, Texas 76104, United States
    Recruiting
    • Study Coordinator · Contact817-413-1500
  • Texas Oncology - Northeast Texas ( Site 8004)
    Tyler, Texas 75702, United States
    Recruiting
    • Study Coordinator · Contact903-535-4688
  • Rambam Health Care Campus ( Site 1402)
    Haifa, 3109601, Israel
    Recruiting
    • Study Coordinator · Contact+97247772688
  • Sourasky Medical Center ( Site 1403)
    Tel Aviv, 6423906, Israel
    Recruiting
    • Study Coordinator · Contact03-6973494
  • Seoul National University Hospital ( Site 2301)
    Seoul, 03080, South Korea
    Recruiting
    • Study Coordinator · Contact+82220724863
  • Samsung Medical Center ( Site 2303)
    Seoul, 06351, South Korea
    Recruiting
    • Study Coordinator · Contact+82-2-3410-1382
  • National Cheng Kung University Hospital ( Site 2601)
    Tainan, 704, Taiwan
    Recruiting
    • Study Coordinator · Contact+88662353535
  • Royal Lancaster Infirmary ( Site 2808)
    Lancaster, Lancashire LA1 4RP, United Kingdom
    Recruiting
    • Study Coordinator · Contact01524516485
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Timeline

4 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Mar 2032, 66 months after the start.

Of 73 industry-sponsored phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 72. This study's planned 66 months is above that.

Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Sep 18, 2026
Primary completionEst.
Mar 19, 2032
CompletionEst.
Oct 22, 2034
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
10 sites added — first sites in South Korea, Taiwan and United Kingdom
Show 10 added (5 United States, 2 South Korea, 1 Israel, 1 Taiwan, 1 United Kingdom)
  • Rambam Health Care Campus ( Site 1402) · Haifa, Israel
  • Texas Oncology - Northeast Texas ( Site 8004) · Tyler, United States
  • Samsung Medical Center ( Site 2303) · Seoul, South Korea
  • National Cheng Kung University Hospital ( Site 2601) · Tainan, Taiwan
  • Lahey Hospital & Medical Center ( Site 0031) · Burlington, United States
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000) · Eugene, United States
  • Texas Oncology - Central/South Texas ( Site 8002) · Austin, United States
  • Seoul National University Hospital ( Site 2301) · Seoul, South Korea
  • Texas Oncology - West Texas ( Site 8009) · Amarillo, United States
  • Royal Lancaster Infirmary ( Site 2808) · Lancaster, United Kingdom
across 4 updates, Oct 6, 2026 – Nov 5, 2026
Show all 4 updates
  1. Nov 5, 2026
    2 sites added — first site in United Kingdom
    Show 2 added (1 United States, 1 United Kingdom)
    • Texas Oncology - West Texas ( Site 8009) · Amarillo, United States
    • Royal Lancaster Infirmary ( Site 2808) · Lancaster, United Kingdom
    + 1 other change: verification date
  2. Oct 29, 2026
    4 sites added
    Show 4 added (3 United States, 1 South Korea)
    • Lahey Hospital & Medical Center ( Site 0031) · Burlington, United States
    • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000) · Eugene, United States
    • Texas Oncology - Central/South Texas ( Site 8002) · Austin, United States
    • Seoul National University Hospital ( Site 2301) · Seoul, South Korea
  3. Oct 21, 2026
    3 sites added — first sites in South Korea and Taiwan
    Show 3 added (1 United States, 1 South Korea, 1 Taiwan)
    • Texas Oncology - Northeast Texas ( Site 8004) · Tyler, United States
    • Samsung Medical Center ( Site 2303) · Seoul, South Korea
    • National Cheng Kung University Hospital ( Site 2601) · Tainan, Taiwan
  4. Oct 6, 2026
    1 site added
    Show site
    • Rambam Health Care Campus ( Site 1402) · Haifa, Israel
    + 1 other change: verification date

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 ↗

10

Registry details

Key details

Study ID
NCT07776691
Collaborators
Daiichi Sankyo
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Sep 18, 2026
Primary completion
Mar 19, 2032 (estimated)
Completion
Oct 22, 2034 (estimated)
Last update
Nov 5, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Raludotatug deruxtecan

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