A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
Start Date
4/15/2025
Completion Date
3/27/2029
Summary
Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. 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 relapsed 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.
Detailed Description
This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Raludotatug Deruxtecan
Carboplatin
Paclitaxel
Bevacizumab
Rescue Medication
Pembrolizumab
Gemcitabine
Pegylated liposomal doxorubicin
Conditions
Locations
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
New Haven, Connecticut 06510
United States
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky 40202
United States
Dana-Farber Cancer Institute ( Site 0015)
Boston, Massachusetts 02215
United States
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York 10065
United States
OU Health University of Oklahoma Medical Center ( Site 7000)
Oklahoma City, Oklahoma 73104
United States
Texas Oncology - DFW ( Site 8000)
Fort Worth, Texas 76104
United States
Houston Methodist Hospital ( Site 0010)
Houston, Texas 77030
United States
START Mountain Region ( Site 0008)
West Valley City, Utah 84119
United States
University of Virginia Health System ( Site 0011)
Charlottesville, Virginia 22908
United States
Centre Hospitalier de l'Université de Montréal ( Site 0102)
Montreal, Quebec H2X 0A9
Canada
McGill University Health Centre ( Site 0100)
Montreal, Quebec H4A 3J1
Canada
Rambam Health Care Campus ( Site 0202)
Haifa, 3109601
Israel
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, 9103102
Israel
Rabin Medical Center ( Site 0203)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 0200)
Ramat Gan, 5265601
Israel
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)
Majadhonda, Madrid 28222
Spain
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de 28027
Spain
Hospital General Universitario de Valencia ( Site 0305)
Valencia, Valenciana, Comunitat 46014
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
Barcelona, 08035
Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre ( Site 0304)
Madrid, 28041
Spain
Hospital Universitario Virgen de la Victoria ( Site 0306)
Málaga, 29010
Spain
University Hospitals Sussex NHS Foundation Trust ( Site 0404)
Brighton, East Sussex BN2 1ES
United Kingdom
Royal Marsden Hospital ( Site 0402)
Fulham, England SW3 6JJ
United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton, England SM2 5PT
United Kingdom
Barts Health NHS Trust ( Site 0401)
London, London, City of E1 1RD
United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0400)
London, London, City of SE1 3SS
United Kingdom
The Christie NHS Foundation Trust ( Site 0405)
Manchester, M20 4BX
United Kingdom