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Looking for participantsPhase1/Phase2

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06843447

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Raludotatug Deruxtecan (biological), Carboplatin (drug), Paclitaxel (drug), Bevacizumab (biological)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Raludotatug Deruxtecan — biological: IV infusion on Day 1 of every 3-week cycle. · Carboplatin — drug: IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. · Paclitaxel — drug: IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. · Bevacizumab — biological: IV infusion on Day 1 of every 3-week cycle. · Rescue Medication — drug: Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol. · Pembrolizumab — biological: IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles. · Gemcitabine — drug: IV injection on days 1 and 8 of each 3-week Cycle · Pegylated liposomal doxorubicin — drug: IV injection administered on Day 1 of each 4-week cycle · MK-2010 — drug: IV infusion on Day 1 of every 3-week cycle
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
605
Started
2025-04-15
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian cancer recurrent
  • • Phase1/Phase2 - 605 participants
  • • Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian cancer recurrent
  • • Female only

Where?

  • • Brighton - University Hospitals Sussex NHS Foundation Trust ( Site 0404)
  • • Fulham - Royal Marsden Hospital ( Site 0402)
  • • Sutton - The Royal Marsden NHS Foundation Trust. ( Site 0403)
  • • London - Barts Health NHS Trust ( Site 0401)
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

More detail

This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.

Ovarian Cancer Recurrent

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

HRD

Treatment history

Treatments you must have had:

  • ✓ received no more than 1 prior bevacizumab-containing systemic treatment regimen
  • ✓ of therapy

What the study is looking for

  • ✓Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer,...
  • ✓Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has...
  • ✓Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in...
  • ✓Has provided tumor tissue for test result research (all cohorts)
  • ✓Has an activity scale performance status of 0 to 1

Who cannot take part

  • ✗Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient...
  • ✗Has uncontrolled or significant cardiovascular disease
  • ✗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...
See the full criteria
Inclusion Criteria: * Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: 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, platinum-sensitive disease) * 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 (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen * Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment * Has provided tumor tissue for biomarker research (all cohorts) * Has an Eastern Cooperative Oncology Group performance status of 0 to 1 * Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: 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, platinum-sensitive disease) and progressed during prior treatment with poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting * Participants in 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, platinum-sensitive disease) * Participants in Cohort C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant Exclusion Criteria: * 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 disorders with potential pulmonary involvement, or prior pneumonectomy * 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

Where Is This Study? (6 UK sites)

University Hospitals Sussex NHS Foundation Trust ( Site 0404)

Brighton BN2 1ES, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 01273 696 955

Royal Marsden Hospital ( Site 0402)

Fulham SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442078118084

The Royal Marsden NHS Foundation Trust. ( Site 0403)

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442078118084

Barts Health NHS Trust ( Site 0401)

London E1 1RD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 7377 7000

Guy s & St Thomas NHS Foundation Trust ( Site 0400)

London SE1 3SS, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 020 7188 7188

The Christie NHS Foundation Trust ( Site 0405)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441619187689

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10