A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
Start Date
7/3/2025
Completion Date
4/1/2031
Summary
The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.
Detailed Description
This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Docetaxel
Ifinatamab Deruxtecan
Opevesostat
Abiraterone
Enzalutamide
Rescue Medication
Conditions
Locations
UCLA Hematology & Oncology ( Site 0003)
Los Angeles, California 90095
United States
University of California-Irvine Medical Center ( Site 0016)
Orange, California 92868
United States
UCSF Medical Center at Mission Bay ( Site 0034)
San Francisco, California 94158
United States
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C., District of Columbia 20010
United States
University of Michigan ( Site 0021)
Ann Arbor, Michigan 48109
United States
Memorial Sloan Kettering Cancer Center ( Site 0006)
New York, New York 10065
United States
UPMC Hillman Cancer Center ( Site 0014)
Pittsburgh, Pennsylvania 15232
United States
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
Germantown, Tennessee 38138
United States
Fred Hutchinson Cancer Center ( Site 0013)
Seattle, Washington 98109
United States
Instituto Alexander Fleming ( Site 0202)
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
La Rioja, F5300COE
Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
Macquarie University, New South Wales 2109
Australia
Liga Norte Riograndense Contra o Câncer ( Site 0271)
Natal, Rio Grande do Norte 59062-000
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital Moinhos de Vento ( Site 0278)
Porto Alegre, Rio Grande do Sul 90035-001
Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
Bragança Paulista, São Paulo 12916-542
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)
Ribeirão Preto, São Paulo 14048900
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)
São José do Rio Preto, São Paulo 15090-000
Brazil
Hospital Alemao Oswaldo Cruz ( Site 0279)
São Paulo, São Paulo 01327-001
Brazil
IPITEC ( Site 0275)
São Paulo, 01221-020
Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
São Paulo, 03102-006
Brazil
BC Cancer - Vancouver Center ( Site 0103)
Vancouver, British Columbia V5Z 4E6
Canada
Sunnybrook Research Institute ( Site 0109)
Toronto, Ontario M4N 3M5
Canada
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario M5G 2M9
Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)
Sherbrooke, Quebec J1H 5N4
Canada
Clinica Universidad Catolica del Maule ( Site 0236)
Talca, Maule Region 3465584
Chile
FALP ( Site 0232)
Santiago, Region M. de Santiago 7500921
Chile
Centro de Oncología de Precisión ( Site 0241)
Santiago, Region M. de Santiago 7560908
Chile
Bradfordhill ( Site 0231)
Santiago, Region M. de Santiago 8420383
Chile
ONCOCENTRO APYS ( Site 0234)
Viña del Mar, Valparaiso 2520598
Chile
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
Bordeaux, Gironde 33000
France
Centre Oscar Lambret ( Site 0495)
Lille, Nord 59000
France
Institut De Cancerologie De L Ouest ( Site 0494)
Saint-Herblain, Pays de la Loire Region 44800
France
Centre Hospitalier de la Cote Basque ( Site 0496)
Bayonne, Pyrenees-Atlantiques 64100
France
centre hospitalier lyon sud ( Site 0497)
Pierre-Bénite, Rhone 69310
France
NCT ( Site 0528)
Heidelberg, Baden-Wurttemberg 69120
Germany
Universitaetsklinikum Ulm. ( Site 0530)
Ulm, Baden-Wurttemberg 89081
Germany
Universitaetsklinikum Jena ( Site 0525)
Jena, Thuringia 07747
Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
Hamburg, 20246
Germany
St Vincent's University Hospital ( Site 0463)
Dublin, Dublin D04 T6F4
Ireland
Beaumont Hospital, Dublin ( Site 0465)
Dublin, D09 V2N0
Ireland
Tallaght University Hospital ( Site 0462)
Dublin, D24 NR0A
Ireland
Rambam Health Care Campus ( Site 0400)
Haifa, 3109601
Israel
Hadassah Medical Center ( Site 0404)
Jerusalem, 9112001
Israel
Rabin Medical Center ( Site 0402)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 0401)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 0403)
Tel Aviv, 6423906
Israel
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
Orbassano, Torino 10143
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
Brescia, 25123
Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
Milan, 20133
Italy
A.O.U. Federico II di Napoli ( Site 0435)
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
Roma, 00168
Italy
Ziekenhuis Gelderse Vallei ( Site 0683)
Ede, Gelderland 6716 RP
Netherlands
UMC St. Radboud ( Site 0679)
Nijmegen, Gelderland 6525 GA
Netherlands
Nij Smellinghe ( Site 0684)
Drachten, Provincie Friesland 9202 NN
Netherlands
Auckland City Hospital ( Site 0831)
Auckland, 1023
New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
Poznan, Greater Poland Voivodeship 60-355
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
Warsaw, Masovian Voivodeship 02-781
Poland
Uniwersyteckie Centrum Kliniczne ( Site 0588)
Gdansk, Pomeranian Voivodeship 80-214
Poland
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
Koszalin, West Pomeranian Voivodeship 75-581
Poland
Asan Medical Center ( Site 0925)
Songpagu, Seoul 05505
South Korea
Severance Hospital Yonsei University Health System ( Site 0924)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 0926)
Seoul, 06351
South Korea
ICO L Hospitalet ( Site 0617)
L Hospitalet Del Llobregat, Barcelona 08908
Spain
Hospital Universitario Ramon y Cajal ( Site 0620)
Madrid, 28034
Spain
Hospital Clinico San Carlos ( Site 0618)
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre ( Site 0622)
Madrid, 28041
Spain
Hospital Universitario Virgen del Rocio ( Site 0619)
Seville, 41013
Spain
Taichung Veterans General Hospital ( Site 0902)
Taichung, 40705
Taiwan
Taipei Veterans General Hospital ( Site 0901)
Taipei, 11217
Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
Adana, 01250
Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
Ankara, 06230
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)
Ankara, 06620
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 0654)
Ankara, 06800
Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 0656)
Istanbul, 34010
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa ( Site 0649)
Istanbul, 34098
Turkey (Türkiye)
Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)
Rize, 53020
Turkey (Türkiye)
Addenbrooke's Hospital ( Site 0747)
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
St Bartholomew's Hospital ( Site 0749)
London, London, City of EC1A 7BE
United Kingdom
Royal Free Hospital ( Site 0743)
London, London, City of NW3 2QG
United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0741)
London, Surrey SM3 5PT
United Kingdom