NCT06843447Recruiting

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

Summary

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Recruiting
Phase: Phase 1 · Phase 2
Study type: Interventional
Countries: Switzerland, United States, Canada, Israel, South Korea, Spain, Taiwan, United Kingdom
Sponsor: Merck Sharp & Dohme LLC(Industry)
Protocol no.: 5909-003
Conditions: Ovarian Cancer Recurrent
Interventions: Biological, Drug

Treatments studied

Raludotatug Deruxtecan
Carboplatin
Paclitaxel
Bevacizumab
Rescue Medication
Pembrolizumab
Gemcitabine
Pegylated liposomal doxorubicin
MK-2010

Collaborators

Daiichi Sankyo

Locations · 38

Basel, SwitzerlandUniversity Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)Recruiting at this site
Lausanne, SwitzerlandCHUV (centre hospitalier universitaire vaudois) ( Site 0800)Recruiting at this site
Sankt Gallen, SwitzerlandHOCH Health Ostschweiz ( Site 0801)Recruiting at this site
New Haven, United StatesYale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)Recruiting at this site
Louisville, United StatesThe University of Louisville, James Graham Brown Cancer Center ( Site 0009)Recruiting at this site
Shreveport, United StatesTRIALS 365 ( Site 0020)Recruiting at this site
Boston, United StatesDana-Farber Cancer Institute ( Site 0015)Recruiting at this site
New York, United StatesMemorial Sloan Kettering Cancer Center ( Site 0003)Recruiting at this site
Oklahoma City, United StatesOU Health University of Oklahoma Medical Center ( Site 7000)Recruiting at this site
Fort Worth, United StatesTexas Oncology - DFW ( Site 8000)Recruiting at this site
West Valley City, United StatesSTART Mountain Region ( Site 0008)Recruiting at this site
Charlottesville, United StatesUniversity of Virginia Health System ( Site 0011)Recruiting at this site
Toronto, CanadaPrincess Margaret Cancer Centre ( Site 0101)Recruiting at this site
Montreal, CanadaCentre Hospitalier de l'Université de Montréal ( Site 0102)Recruiting at this site
Montreal, CanadaMcGill University Health Centre ( Site 0100)Recruiting at this site
Haifa, IsraelRambam Health Care Campus ( Site 0202)Recruiting at this site
Jerusalem, IsraelShaare Zedek Medical Center ( Site 0201)Recruiting at this site
Petah Tikva, IsraelRabin Medical Center ( Site 0203)Recruiting at this site
Ramat Gan, IsraelSheba Medical Center ( Site 0200)Recruiting at this site
Goyang-si, South KoreaNational Cancer Center ( Site 2004)Recruiting at this site
Seoul, South KoreaSeoul National University Hospital ( Site 2000)Recruiting at this site
Seoul, South KoreaSeverance Hospital, Yonsei University Health System ( Site 2002)Recruiting at this site
Seoul, South KoreaAsan Medical Center ( Site 2003)Recruiting at this site
L'Hospitalet de Llobregat, SpainInstitut Català d'Oncologia - L'Hospitalet ( Site 0302)Recruiting at this site
Majadhonda, SpainHOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)Recruiting at this site
Madrid, SpainClinica Universidad de Navarra ( Site 0301)Recruiting at this site
Valencia, SpainHospital General Universitario de Valencia ( Site 0305)Recruiting at this site
Barcelona, SpainHospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)Recruiting at this site
Madrid, SpainHospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)Recruiting at this site
Madrid, SpainHospital Universitario 12 de Octubre ( Site 0304)Recruiting at this site

In total, worldwide, 38 of the 39 sites listed in the registry are recruiting; the other one is not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 21, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 8 more locations

Other identifiers

MK-5909-003 · other identifier
2024-514674-47-00 · other registry
U1111-1308-2821 · other registry
REJOICE-Ovarian02 · other identifier

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.