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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
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

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Western Health-Sunshine & Footscray Hospitals ( Site 1002)
Coordinator of this site? Confirm its status
St AlbansAustraliaRecruiting
Centre Hospitalier de l'Université de Montréal ( Site 0102)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
McGill University Health Centre ( Site 0100)
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Princess Margaret Cancer Centre ( Site 0101)
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)
Coordinator of this site? Confirm its status
BaselSwitzerlandRecruiting
CHUV (centre hospitalier universitaire vaudois) ( Site 0800)
Coordinator of this site? Confirm its status
LausanneSwitzerlandRecruiting
HOCH Health Ostschweiz ( Site 0801)
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clinica Universidad de Navarra
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Coordinator of this site? Confirm its status
MajadahondaSpainRecruiting
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
University Hospitals Sussex NHS Foundation Trust ( Site 0404)
Coordinator of this site? Confirm its status
BrightonUnited KingdomRecruiting
Royal Marsden Hospital ( Site 0402)
Coordinator of this site? Confirm its status
FulhamUnited KingdomRecruiting
Guy s & St Thomas NHS Foundation Trust ( Site 0400)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Barts Health NHS Trust ( Site 0401)
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust ( Site 0405)
Coordinator of this site? Confirm its status
ManchesterUnited KingdomRecruiting
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting
Rambam Health Care Campus ( Site 0202)
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center ( Site 0201)
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Rabin Medical Center ( Site 0203)
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
Sheba Medical Center ( Site 0200)
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
National Cancer Center ( Site 2004)
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
Asan Medical Center ( Site 2003)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System ( Site 2002)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital ( Site 2000)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
National Taiwan University Hospital ( Site 3001)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Dana-Farber Cancer Institute ( Site 0015)
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Virginia Health System ( Site 0011)
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
Texas Oncology - DFW ( Site 8000)
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Houston Methodist Hospital ( Site 0010)
Coordinator of this site? Confirm its status
HoustonUnited StatesCompleted
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center ( Site 0003)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
OU Health University of Oklahoma Medical Center ( Site 7000)
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
TRIALS 365 ( Site 0020)
Coordinator of this site? Confirm its status
ShreveportUnited StatesRecruiting
START Mountain Region ( Site 0008)
Coordinator of this site? Confirm its status
West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.