NCT06843447Recrutement en cours
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Résumé
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.
Critères d'inclusion
• 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
Critères d'exclusion
• 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
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 1 · Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse, États-Unis, Canada, Israël, Corée du Sud, Espagne, Taïwan, Royaume-Uni
- Promoteur
- Merck Sharp & Dohme LLC(Industrie)
- N° de protocole
- 5909-003
- Pathologies
- Ovarian Cancer Recurrent
- Interventions
- Biologique, Médicament
Traitements évalués
- Raludotatug Deruxtecan
- Carboplatin
- Paclitaxel
- Bevacizumab
- Rescue Medication
- Pembrolizumab
- Gemcitabine
- Pegylated liposomal doxorubicin
- MK-2010
Collaborateurs
Daiichi Sankyo
Lieux · 38
- Basel, SuisseUniversity Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)Recrute dans ce centre
- Lausanne, SuisseCHUV (centre hospitalier universitaire vaudois) ( Site 0800)Recrute dans ce centre
- Sankt Gallen, SuisseHOCH Health Ostschweiz ( Site 0801)Recrute dans ce centre
- New Haven, États-UnisYale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)Recrute dans ce centre
- Louisville, États-UnisThe University of Louisville, James Graham Brown Cancer Center ( Site 0009)Recrute dans ce centre
- Shreveport, États-UnisTRIALS 365 ( Site 0020)Recrute dans ce centre
- Boston, États-UnisDana-Farber Cancer Institute ( Site 0015)Recrute dans ce centre
- New York, États-UnisMemorial Sloan Kettering Cancer Center ( Site 0003)Recrute dans ce centre
- Oklahoma City, États-UnisOU Health University of Oklahoma Medical Center ( Site 7000)Recrute dans ce centre
- Fort Worth, États-UnisTexas Oncology - DFW ( Site 8000)Recrute dans ce centre
- West Valley City, États-UnisSTART Mountain Region ( Site 0008)Recrute dans ce centre
- Charlottesville, États-UnisUniversity of Virginia Health System ( Site 0011)Recrute dans ce centre
- Toronto, CanadaPrincess Margaret Cancer Centre ( Site 0101)Recrute dans ce centre
- Montreal, CanadaCentre Hospitalier de l'Université de Montréal ( Site 0102)Recrute dans ce centre
- Montreal, CanadaMcGill University Health Centre ( Site 0100)Recrute dans ce centre
- Haifa, IsraëlRambam Health Care Campus ( Site 0202)Recrute dans ce centre
- Jerusalem, IsraëlShaare Zedek Medical Center ( Site 0201)Recrute dans ce centre
- Petah Tikva, IsraëlRabin Medical Center ( Site 0203)Recrute dans ce centre
- Ramat Gan, IsraëlSheba Medical Center ( Site 0200)Recrute dans ce centre
- Goyang-si, Corée du SudNational Cancer Center ( Site 2004)Recrute dans ce centre
- Seoul, Corée du SudSeoul National University Hospital ( Site 2000)Recrute dans ce centre
- Seoul, Corée du SudSeverance Hospital, Yonsei University Health System ( Site 2002)Recrute dans ce centre
- Seoul, Corée du SudAsan Medical Center ( Site 2003)Recrute dans ce centre
- L'Hospitalet de Llobregat, EspagneInstitut Català d'Oncologia - L'Hospitalet ( Site 0302)Recrute dans ce centre
- Majadhonda, EspagneHOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)Recrute dans ce centre
- Madrid, EspagneClinica Universidad de Navarra ( Site 0301)Recrute dans ce centre
- Valencia, EspagneHospital General Universitario de Valencia ( Site 0305)Recrute dans ce centre
- Barcelona, EspagneHospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)Recrute dans ce centre
- Madrid, EspagneHospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)Recrute dans ce centre
- Madrid, EspagneHospital Universitario 12 de Octubre ( Site 0304)Recrute dans ce centre
Au total, dans le monde, 38 des 39 centres listés au registre recrutent ; l'autre ne recrute pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 21 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 8 autres lieux
Autres identifiants
- MK-5909-003 · autre identifiant
- 2024-514674-47-00 · autre registre
- U1111-1308-2821 · autre registre
- REJOICE-Ovarian02 · autre identifiant
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.