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Taking people in United KingdomPhase 1/2

Tests raludotatug deruxtecan, alone or with other drugs, in ovarian cancer

Tests a targeted antibody drug in adults with returned high-grade serous ovarian cancer.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Brighton, Fulham, London, Manchester, and Sutton, United KingdomSee the 6 sitesAlso in 8 other countries, 36 sites
Trial code
Registry title
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Status
Recruiting
Phase
Phase 1/2
People taking part
605 people, planned
Started
15 Apr 2025
Expected to end
7 Feb 2031
Type of study
Interventional, 14 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Raludotatug Deruxtecan
  • Carboplatin
  • Paclitaxel
  • Bevacizumab
  • Rescue Medication
  • Pembrolizumab
  • Gemcitabine
  • Pegylated liposomal doxorubicin
  • MK-2010
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with advanced high-grade serous or high-grade endometrioid ovarian, primary peritoneal or fallopian tube cancer. Which group a person joins depends on how the cancer came back after earlier treatment.

Age
18 years and older
Sex
Women only
Disease stage
High-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. Most groups need a cancer that came back after 1 to 3 earlier treatments and can be measured on scans. One group needs a new Stage III or Stage IV diagnosis that is non-HRD-positive.
Earlier treatment
Depends on the group. Some groups need the cancer to have grown 6 months or more after platinum-based treatment. Others need it to have grown less than 6 months after. Some need it to have grown during earlier PARP inhibitor treatment. No more than 1 earlier bevacizumab treatment in some groups. Cannot have had cadherin-6-targeted treatment.
Biomarker or test result
A tumour tissue sample must be given for biomarker research. The new-diagnosis group needs non-HRD-positive disease.

Main reasons for not taking part

  • Stroke, mini-stroke or other artery blood clot in the last 6 months
  • Uncontrolled or significant heart disease
  • Any history of interstitial lung disease or pneumonitis, or severe lung problems
  • Peripheral neuropathy of Grade 2 or higher
  • Active brain metastases or carcinomatous meningitis

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
  • 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 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 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 uncontrolled or significant cardiovascular disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has ≥Grade 2 peripheral neuropathy
  • Has known active CNS metastases and/or carcinomatous meningitis

Where in United Kingdom

Also in 8 other countries, 36 sites

  • University Hospitals Sussex NHS Foundation Trust (Site 0404)Brighton, United KingdomContact: Study CoordinatorTaking people
  • Royal Marsden Hospital (Site 0402)Fulham, United KingdomContact: Study CoordinatorTaking people
  • Barts Health NHS Trust (Site 0401)London, United KingdomContact: Study CoordinatorTaking people
  • Guy s & St Thomas NHS Foundation Trust (Site 0400)London, United KingdomContact: Study CoordinatorTaking people
  • The Christie NHS Foundation Trust (Site 0405)Manchester, United KingdomContact: Study CoordinatorTaking people
  • The Royal Marsden NHS Foundation Trust. (Site 0403)Sutton, United KingdomContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 14 groups in the trial

  • Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)Treatment being tested

    Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Carboplatin, and Rescue Medication

  • Cohort A-1 Arm 2 (R-DXd + Paclitaxel)Treatment being tested

    Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Paclitaxel, and Rescue Medication

  • Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2)Treatment being tested

    Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Carboplatin, and Rescue Medication

  • Cohort B-1 (R-DXd + Bevacizumab)Treatment being tested

    Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Bevacizumab, and Rescue Medication

  • Cohort B-2 (R-DXd RP2D + Bevacizumab)Treatment being tested

    Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Bevacizumab, and Rescue Medication

  • Cohort C-1 (R-DXd + Pembrolizumab)Treatment being tested

    Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Rescue Medication, and Pembrolizumab

  • Cohort D (R-DXd +/- Bevacizumab)Treatment being tested

    Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Bevacizumab, and Rescue Medication

  • Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab)Treatment being tested

    Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Carboplatin, Bevacizumab, and Rescue Medication

  • Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab)Treatment being tested

    Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Paclitaxel, Bevacizumab, and Rescue Medication

  • Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab)Existing treatment, for comparison

    Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation.

    Treatment: Carboplatin, Paclitaxel, Bevacizumab, Gemcitabine, and Pegylated liposomal doxorubicin

  • Cohort E-1 (R-DXd + MK-2010)Treatment being tested

    Participants receive escalating doses of IV R-DXd in combination with MK-2010. Participants can receive up to a maximum of thirty-five 3-week cycles of MK-2010 (approximately 2 years) and will receive R-DXd until disease progression or discontinuation.

    Treatment: Raludotatug Deruxtecan, Rescue Medication, and MK-2010

  • Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab)Treatment being tested

    Participants will receive carboplatin (Dose 1 or Dose 2), paclitaxel (five 3-week cycles), and pembrolizumab during the induction phase. During the maintenance phase, participants will receive RP2D of IV R-DXd (up to 2 years; participants with PR or SD at 2 years may continue until disease progression) in combination with pembrolizumab (up to thirty-five 3-week cycles).

    Treatment: Raludotatug Deruxtecan, Carboplatin, Paclitaxel, and Pembrolizumab

  • Cohort C-2 Arm 2 (Carboplatin + Paclitaxel)Treatment being tested

    Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation.

    Treatment: Carboplatin and Paclitaxel

  • Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab)Treatment being tested

    Participants with PSROC will receive RP2D of R-DXd in combination with pembrolizumab (up to thirty-five 3-week cycles) and bevacizumab until progressive disease.

    Treatment: Raludotatug Deruxtecan, Bevacizumab, and Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With Advanced High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian02)
Plain-language title
Tests raludotatug deruxtecan, alone or with other drugs, in ovarian cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 November 2026