NCT06843447RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
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)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 605 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 27 Mar 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ovarian cancer
- NCT number
- NCT06843447
- EU CT number
- 2024-514674-47-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 605
- From 15 Apr 2025 to the primary completion date, 27 Mar 2029
- 40 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Has ≥Grade 2 peripheral neuropathy
- Has known active CNS metastases and/or carcinomatous meningitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Western Health-Sunshine & Footscray Hospitals ( Site 1002) Coordinator of this site? Confirm its status | St Albans | Australia | Recruiting |
| Centre Hospitalier de l'Université de Montréal ( Site 0102) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Centre ( Site 0100) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Princess Margaret Cancer Centre ( Site 0101) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802) Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| CHUV (centre hospitalier universitaire vaudois) ( Site 0800) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| HOCH Health Ostschweiz ( Site 0801) Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| University Hospitals Sussex NHS Foundation Trust ( Site 0404) Coordinator of this site? Confirm its status | Brighton | United Kingdom | Recruiting |
| Royal Marsden Hospital ( Site 0402) Coordinator of this site? Confirm its status | Fulham | United Kingdom | Recruiting |
| Guy s & St Thomas NHS Foundation Trust ( Site 0400) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Barts Health NHS Trust ( Site 0401) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust ( Site 0405) Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| The Royal Marsden NHS Foundation Trust. ( Site 0403) Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Rambam Health Care Campus ( Site 0202) Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center ( Site 0201) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center ( Site 0203) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba Medical Center ( Site 0200) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| National Cancer Center ( Site 2004) Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Asan Medical Center ( Site 2003) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 2002) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital ( Site 2000) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| National Taiwan University Hospital ( Site 3001) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Dana-Farber Cancer Institute ( Site 0015) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Virginia Health System ( Site 0011) Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Texas Oncology - DFW ( Site 8000) Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Houston Methodist Hospital ( Site 0010) Coordinator of this site? Confirm its status | Houston | United States | Completed |
| The University of Louisville, James Graham Brown Cancer Center ( Site 0009) Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019) Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 0003) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| OU Health University of Oklahoma Medical Center ( Site 7000) Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| TRIALS 365 ( Site 0020) Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| START Mountain Region ( Site 0008) Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.