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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Official title: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1440
Start Date
2025-05-13
Completion Date
2031-01-06
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Ifinatamab deruxtecan
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Docetaxel
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Prednisone
Oral tablet administered once per day or per approved product label
Rescue Medication
Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label
Locations (303)
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, United States
Community Cancer Institute ( Site 0081)
Clovis, California, United States
City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, United States
City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, United States
Moores Cancer Center ( Site 0010)
La Jolla, California, United States
Veterans Affairs Long Beach Healthcare System ( Site 0058)
Long Beach, California, United States
Cedars-Sinai Medical Center ( Site 0068)
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0002)
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)
Orange, California, United States
Stanford Cancer Center ( Site 0046)
Palo Alto, California, United States
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)
Aurora, Colorado, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)
New Haven, Connecticut, United States
Veterans Affairs Connecticut Healthcare System ( Site 0062)
West Haven, Connecticut, United States
The GW Medical Faculty Associates ( Site 0057)
Washington D.C., District of Columbia, United States
Washington DC Veterans Affairs Medical Center ( Site 0056)
Washington D.C., District of Columbia, United States
Clermont Oncology Center ( Site 0087)
Clermont, Florida, United States
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)
Jacksonville, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0086)
Orange City, Florida, United States
Emory University School of Medicine- Grady Campus ( Site 0103)
Atlanta, Georgia, United States
Winship Cancer Institute, Emory University ( Site 0003)
Atlanta, Georgia, United States
Rush University Medical Center-Hematology and Oncology ( Site 0028)
Chicago, Illinois, United States
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)
Chicago, Illinois, United States
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, United States
Greenebaum Comprehensive Cancer Center ( Site 0021)
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center ( Site 0043)
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0012)
Boston, Massachusetts, United States
University of Michigan ( Site 0005)
Ann Arbor, Michigan, United States
Henry Ford Hospital ( Site 0035)
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 0015)
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)
Rochester, Minnesota, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Center at Regions Hospital ( Site 0052)
Saint Paul, Minnesota, United States
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)
Grand Island, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada ( Site 0082)
Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, United States
University of New Mexico Comprehensive Cancer Center ( Site 0022)
Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai ( Site 0009)
New York, New York, United States
Great Lakes Cancer Care ( Site 0047)
Williamsville, New York, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)
Columbus, Ohio, United States
VA Portland Health Care System ( Site 0038)
Portland, Oregon, United States
Perelman Center for Advanced Medicine ( Site 0067)
Philadelphia, Pennsylvania, United States
Abramson Cancer Center - Penn Medicine ( Site 0079)
Philadelphia, Pennsylvania, United States
Memphis VA Medical Center ( Site 0072)
Memphis, Tennessee, United States
SCRI Oncology Partners ( Site 0074)
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic ( Site 0042)
Nashville, Tennessee, United States
Parkland Health & Hospital System ( Site 0069)
Dallas, Texas, United States
UT Southwestern Medical Center ( Site 0039)
Dallas, Texas, United States
University of Texas-MD Anderson Cancer Center ( Site 0055)
Houston, Texas, United States
Blue Ridge Cancer Care ( Site 0024)
Roanoke, Virginia, United States
VA Puget Sound Health Care System ( Site 0054)
Seattle, Washington, United States
Fred Hutchinson Cancer Center ( Site 0060)
Seattle, Washington, United States
University Hospital and UW Health Clinics ( Site 0065)
Madison, Wisconsin, United States
Medical College of Wisconsin ( Site 0008)
Milwaukee, Wisconsin, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
Berazategui, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)
Mar del Plata, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0125)
Mar del Plata, Buenos Aires, Argentina
Sanatorio Parque ( Site 0126)
Rosario, Santa Fe Province, Argentina
Centro Medico Dra De Salvo ( Site 0132)
CABA, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)
La Rioja, Argentina
Centro Oncologico de Integracion Regional. COIR ( Site 0130)
Mendoza, Argentina
Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)
Salta, Argentina
Instituto San Marcos ( Site 0137)
San Juan, Argentina
Blacktown Hospital ( Site 0154)
Blacktown, New South Wales, Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 0151)
Macquarie University, New South Wales, Australia
Gallipoli Medical Research Ltd ( Site 0153)
Greenslopes, Queensland, Australia
Peter MacCallum Cancer Centre ( Site 0152)
Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0155)
Murdock, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH ( Site 0171)
Wels, Upper Austria, Austria
Uniklinikum Salzburg Universitaetsklinik für Innere Medizin III ( Site 0172)
Salzburg, Austria
Hospital Mario Penna ( Site 0179)
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário Evangélico Mackenzie ( Site 0181)
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0184)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Base de São José do Rio Preto ( Site 0176)
São José do Rio Preto, São Paulo, Brazil
IPITEC ( Site 0189)
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0183)
São Paulo, Brazil
Fundación Arturo López Pérez ( Site 0201)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0200)
Santiago, Region M. de Santiago, Chile
Peking University First Hospital ( Site 1434)
Beijing, Beijing Municipality, China
Shanghai General Hospital ( Site 1449)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chonqing Medical University ( Site 1406)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 1405)
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Fujian Medical University ( Site 1452)
Fuzhou, Fujian, China
Guangzhou First People's Hospital ( Site 1410)
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center ( Site 1467)
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1402)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center ( Site 1409)
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 1459)
Zhuhai, Guangdong, China
Guangxi Medical University Cancer Hospital ( Site 1414)
Nanning, Guangxi, China
Henan Cancer Hospital ( Site 1472)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1424)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 1411)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)
Nanjing, Jiangsu, China
Jiangsu Province Hospital ( Site 1426)
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University ( Site 1427)
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 1438)
Xuzhou, Jiangsu, China
Jilin Province People's Hospital ( Site 1461)
Changchun, Jilin, China
The first affiliated Hospital of Xi an Jiaotong University ( Site 1408)
Xi'an, Shaanxi, China