Prostate CancerPhase 3NCT06925737
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
A Phase 3 study testing Ifinatamab deruxtecan, Docetaxel and Prednisone in people with Prostate Cancer and Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 303 sites in 35 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- Ifinatamab deruxtecan, Docetaxel and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 303 sitesin 35 countries
- Study dates
- 13 May 2025to 6 Jan 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
- Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
- Has recovered from adverse events (AEs) due to previous anticancer therapies
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Is unable to swallow tablets/capsules
- Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
- Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
- Has current ILD/pneumonitis
- Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
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- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has uncontrolled or significant cardiovascular disease
- Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
- Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
- Has a "superscan" bone scan
Trial locations and contacts
303 sites in 35 countries. Contact the study team or a site near you to ask about taking part.
303 sites in 35 countries
United States55 sites, 51 recruiting
- Recruiting
University of New Mexico Comprehensive Cancer Center ( Site 0022)
Albuquerque, New Mexico, 87131
Study Coordinator, 505-272-4946
- Recruiting
University of Michigan ( Site 0005)
Ann Arbor, Michigan, 48109
Study Coordinator, 734-647-8902
- Recruiting
Emory University School of Medicine- Grady Campus ( Site 0103)
Atlanta, Georgia, 30303
Study Coordinator, 404-727-6123
- Recruiting
Winship Cancer Institute, Emory University ( Site 0003)
Atlanta, Georgia, 30322
Study Coordinator, 404-778-4824
- Recruiting
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)
Aurora, Colorado, 80045
Study Coordinator, 303-399-8020
- Recruiting
Greenebaum Comprehensive Cancer Center ( Site 0021)
Baltimore, Maryland, 21201
Study Coordinator, 410-707-4011
- Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, 59102
Study Coordinator, 406-238-6290
- Recruiting
Beth Israel Deaconess Medical Center ( Site 0043)
Boston, Massachusetts, 02215
Study Coordinator, 617-667-2100
- Recruiting
Dana Farber Cancer Institute ( Site 0012)
Boston, Massachusetts, 02215
Study Coordinator, 617-632-6049
- Recruiting
Rush University Medical Center-Hematology and Oncology ( Site 0028)
Chicago, Illinois, 60607
Study Coordinator, 312-563-2531
- Recruiting
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)
Chicago, Illinois, 60612
Study Coordinator, 312-355-1625
- Recruiting
Clermont Oncology Center ( Site 0087)
Clermont, Florida, 34711
Study Coordinator, 386-538-3169
- Recruiting
Community Cancer Institute ( Site 0081)
Clovis, California, 93611
Study Coordinator, 559-387-1600
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)
Columbus, Ohio, 43221
Study Coordinator, 619-228-4010
- Recruiting
Parkland Health & Hospital System ( Site 0069)
Dallas, Texas, 75235
Study Coordinator, 214-645-4673
- Recruiting
UT Southwestern Medical Center ( Site 0039)
Dallas, Texas, 75390
Study Coordinator, 972-332-4682
- Recruiting
Henry Ford Hospital ( Site 0035)
Detroit, Michigan, 48202
Study Coordinator, 313-725-7920
- Recruiting
City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, 91010
Study Coordinator, 626-256-4673
- Completed
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)
Grand Island, Nebraska, 68803
- Recruiting
Cancer and Hematology Centers of Western Michigan ( Site 0015)
Grand Rapids, Michigan, 49503
Study Coordinator, 616-399-6500
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, 07601
Study Coordinator, 551-996-5900
- Recruiting
University of Texas-MD Anderson Cancer Center ( Site 0055)
Houston, Texas, 77030
Study Coordinator, 877-632-6789
- Recruiting
City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, 92618
Study Coordinator, 626-256-4673
- Recruiting
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)
Jacksonville, Florida, 32224
Study Coordinator, 855-776-0015
- Recruiting
Moores Cancer Center ( Site 0010)
La Jolla, California, 92093
Study Coordinator, 858-822-6100
- Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0082)
Las Vegas, Nevada, 89148
Study Coordinator, 702-952-1251
- Recruiting
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, 40536
Study Coordinator, 866-340-4488
- Recruiting
Veterans Affairs Long Beach Healthcare System ( Site 0058)
Long Beach, California, 90822
Study Coordinator, 562-826-8000
- Recruiting
Cedars-Sinai Medical Center ( Site 0068)
Los Angeles, California, 90048
Study Coordinator, 310-423-7600
- Recruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0002)
Los Angeles, California, 90404
Study Coordinator, 310-825-2631
- Recruiting
University Hospital and UW Health Clinics ( Site 0065)
Madison, Wisconsin, 53792
Study Coordinator, 608-915-0100
- Recruiting
Memphis VA Medical Center ( Site 0072)
Memphis, Tennessee, 38105
Study Coordinator, 901-523-8990
- Recruiting
Medical College of Wisconsin ( Site 0008)
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-805-0509
- Recruiting
SCRI Oncology Partners ( Site 0074)
Nashville, Tennessee, 37203
Study Coordinator, 615-329-7640
- Recruiting
Henry-Joyce Cancer Clinic ( Site 0042)
Nashville, Tennessee, 37232
Study Coordinator, 615-936-8422
- Recruiting
Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)
New Haven, Connecticut, 06510
Study Coordinator, 203-737-6087
- Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0009)
New York, New York, 10029
Study Coordinator, 212-241-6756
- Completed
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, 68130
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)
Orange, California, 92868
Study Coordinator, 714-509-2371
- Recruiting
Mid Florida Hematology and Oncology Center ( Site 0086)
Orange City, Florida, 32763
Study Coordinator, 386-774-1223
- Recruiting
Stanford Cancer Center ( Site 0046)
Palo Alto, California, 94304
Study Coordinator, 650-725-2078
- Recruiting
Perelman Center for Advanced Medicine ( Site 0067)
Philadelphia, Pennsylvania, 19104
Study Coordinator, 215-360-0737
- Recruiting
Abramson Cancer Center - Penn Medicine ( Site 0079)
Philadelphia, Pennsylvania, 19106
Study Coordinator, 215-829-6088
- Recruiting
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, 85054
Study Coordinator, 855-776-0015
- Recruiting
VA Portland Health Care System ( Site 0038)
Portland, Oregon, 97239
Study Coordinator, 503-220-8262
- Active, not recruiting
Blue Ridge Cancer Care ( Site 0024)
Roanoke, Virginia, 24014
- Recruiting
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)
Rochester, Minnesota, 55905
Study Coordinator, 855-776-0015
- Recruiting
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)
Saint Louis Park, Minnesota, 55426
Study Coordinator, 612-341-4800
- Recruiting
HealthPartners Cancer Center at Regions Hospital ( Site 0052)
Saint Paul, Minnesota, 55101
Study Coordinator, 612-341-4800
- Recruiting
VA Puget Sound Health Care System ( Site 0054)
Seattle, Washington, 98108
Study Coordinator, 206-762-1010
- Recruiting
Fred Hutchinson Cancer Center ( Site 0060)
Seattle, Washington, 98109
Study Coordinator, 206-606-7307
- Completed
The GW Medical Faculty Associates ( Site 0057)
Washington D.C., District of Columbia, 20037
- Recruiting
Washington DC Veterans Affairs Medical Center ( Site 0056)
Washington D.C., District of Columbia, 20422
Study Coordinator, 202-745-8000
- Recruiting
Veterans Affairs Connecticut Healthcare System ( Site 0062)
West Haven, Connecticut, 06516
Study Coordinator, 203-932-5711
- Recruiting
Great Lakes Cancer Care ( Site 0047)
Williamsville, New York, 14221
Study Coordinator, 716-884-3000
China34 sites, 34 recruiting
- Recruiting
Peking University First Hospital ( Site 1434)
Beijing, Beijing Municipality, 100034
Study Coordinator, 010-83572505
- Recruiting
Shanghai General Hospital ( Site 1449)
Beijing, Beijing Municipality, 200080
Study Coordinator, 021-36126255
- Recruiting
Jilin Province People's Hospital ( Site 1461)
Changchun, Jilin, 130021
Study Coordinator, 0431-8595238
- Recruiting
Hunan Cancer Hospital ( Site 1411)
Changsha, Hunan, 410013
Study Coordinator, 0731-89762271
- Recruiting
West China Hospital of Sichuan University ( Site 1451)
Chengdu, Sichuan, 610041
Study Coordinator, +8618980606710
- Recruiting
West China Hospital, Sichuan University ( Site 1468)
Chengdu, Sichuan, 610041
Study Coordinator, 028-85422114
- Recruiting
The First Affiliated Hospital of Chonqing Medical University ( Site 1406)
Chongqing, Chongqing Municipality, 400016
Study Coordinator, 02389012012
- Recruiting
Chongqing University Three Gorges Hospital ( Site 1405)
Chongqing, Chongqing Municipality, 404199
Study Coordinator, 02358104650
- Recruiting
The First Affiliated Hospital Of Fujian Medical University ( Site 1452)
Fuzhou, Fujian, 350005
Study Coordinator, 0591-87981262
- Recruiting
Guangzhou First People's Hospital ( Site 1410)
Guangzhou, Guangdong, 510000
Study Coordinator, 020-81048888
- Recruiting
Sun Yat-Sen University Cancer Center ( Site 1467)
Guangzhou, Guangdong, 510060
Study Coordinator, 020-87343565
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1402)
Guangzhou, Guangdong, 510220
Study Coordinator, 020-81332199
- Recruiting
Sun Yat-sen University Cancer Center ( Site 1409)
Guangzhou, Guangdong, 510300
Study Coordinator, +862066673666
- Recruiting
Zhejiang Cancer Hospital ( Site 1447)
Hangzhou, Zhejiang, 310022
Study Coordinator, 0571-88122222
- Recruiting
The First Hospital of Jiaxing ( Site 1416)
Jiaxing, Zhejiang, 314001
Study Coordinator, 0573-82519999
- Recruiting
Shandong Cancer Hospital ( Site 1421)
Jinan, Shandong, 250117
Study Coordinator, 0531-67626986
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)
Nanjing, Jiangsu, 210008
Study Coordinator, 02583106666
- Recruiting
Jiangsu Province Hospital ( Site 1426)
Nanjing, Jiangsu, 210029
Study Coordinator, 025-68306259
- Recruiting
Zhongda Hospital Southeast University ( Site 1427)
Nanjing, Jiangsu, 214023
Study Coordinator, 025-83272084
- Recruiting
Guangxi Medical University Cancer Hospital ( Site 1414)
Nanning, Guangxi, 530201
Study Coordinator, 0771-5331955
- Recruiting
The First Affiliated Hospital of Ningbo University ( Site 1419)
Ningbo, Zhejiang, 315010
Study Coordinator, 86057487085146
- Recruiting
Shanghai Tenth People's Hospital ( Site 1441)
Shanghai, Shanghai Municipality, 200000
Study Coordinator, 021-66300588
- Recruiting
Fudan University Shanghai Cancer Center ( Site 1400)
Shanghai, Shanghai Municipality, 200032
Study Coordinator, 021-64175590
- Recruiting
Zhongshan Hospital Fudan University ( Site 1430)
Shanghai, Shanghai Municipality, 200032
Study Coordinator, 8602131587861
- Recruiting
Shanghai Tongji Hospital ( Site 1412)
Shanghai, Shanghai Municipality, 200065
Study Coordinator, 021-56051080
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1457)
Shanghai, Shanghai Municipality, 200127
Study Coordinator, 021-58752345
- Recruiting
First Affiliated Hospital Of Shanxi Medical University ( Site 1460)
Taiyuan, Shanxi, 030001
Study Coordinator, +86 0351-4639766
- Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 1469)
Ürümqi, Xinjiang, 830000
Study Coordinator, 0991-7968088
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University ( Site 1437)
Wenzhou, Zhejiang, 325000
Study Coordinator, 057755579999
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1424)
Wuhan, Hubei, 430022
Study Coordinator, 027-85726114
- Recruiting
The first affiliated Hospital of Xi an Jiaotong University ( Site 1408)
Xi'an, Shaanxi, 710061
Study Coordinator, 029-85323112
- Recruiting
The Affiliated Hospital of Xuzhou Medical University ( Site 1438)
Xuzhou, Jiangsu, 221002
Study Coordinator, 0516-85806507
- Recruiting
Henan Cancer Hospital ( Site 1472)
Zhengzhou, Henan, 450008
Study Coordinator, 400-0371-818
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 1459)
Zhuhai, Guangdong, 51900
Study Coordinator, +8607562528188
Japan31 sites, 28 recruiting
- Recruiting
University of Yamanashi Hospital ( Site 1506)
Chūō, Yamanashi, 409-3898
Study Coordinator, +81-55-273-9325
- Recruiting
Harasanshin Hospital ( Site 1517)
Fukuoka, 812-0033
Study Coordinator, +81-92-291-3434
- Recruiting
Kyushu University Hospital ( Site 1515)
Fukuoka, 812-8582
Study Coordinator, +81926425774
- Recruiting
Gifu University Hospital ( Site 1527)
Gifu, 501-1194
Study Coordinator, +81-58-230-6000
- Recruiting
University of the Ryukyus Hospital ( Site 1519)
Ginowan, Okinawa, 901-2725
Study Coordinator, +81-98-894-1455
- Recruiting
Hamamatsu University Hospital ( Site 1520)
Hamamatsu, Shizuoka, 431-3192
Study Coordinator, +81-53-435-2111
- Recruiting
Hiroshima University Hospital ( Site 1512)
Hiroshima, 734-8551
Study Coordinator, +81-82-257-5555
- Completed
Kagoshima University Hospital ( Site 1518)
Kagoshima, 890-8520
- Completed
Kagoshima City Hospital ( Site 1528)
Kagoshima, 890-8760
- Recruiting
Kanazawa Medical University Hospital ( Site 1507)
Kahoku-gun, Ishikawa-ken, 920-0293
Study Coordinator, +81-76-286-3511
- Recruiting
Shonan Kamakura General Hospital ( Site 1530)
Kamakura, Kanagawa, 247-8533
Study Coordinator, +81-467-46-1717
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan ( Site 1510)
Kitakyushu, Fukuoka, 807-8556
Study Coordinator, +81-93-691-7503
- Recruiting
Kobe University Hospital ( Site 1511)
Kobe, Hyōgo, 650-0017
Study Coordinator, +81-78-382-5111
- Recruiting
Dokkyo Medical University Saitama Medical Center ( Site 1502)
Koshigaya, Saitama, 343-8555
Study Coordinator, +81-48-965-1111
- Recruiting
National Hospital Organization Kumamoto Medical Center ( Site 1524)
Kumamoto, 860-0008
Study Coordinator, +81-96-353-6501
- Recruiting
Kurume University Hospital ( Site 1516)
Kurume, Fukuoka, 830-0011
Study Coordinator, +81-942-35-3311
- Recruiting
University Hospital,Kyoto Prefectural University of Medicine ( Site 1525)
Kyoto, 602-8566
Study Coordinator, +81-75-251-5111
- Recruiting
The Jikei University Hospital ( Site 1504)
Minato, Tokyo, 105-8471
Study Coordinator, +81-3-3433-1111
- Recruiting
Nagano Municipal Hospital ( Site 1526)
Nagano, 381-8551
Study Coordinator, +81-26-295-1199
- Recruiting
Nagasaki University Hospital ( Site 1523)
Nagasaki, 852-8501
Study Coordinator, +81-958-19-7200
- Recruiting
Nagoya University Hospital ( Site 1508)
Nagoya, Aichi-ken, 466-8560
Study Coordinator, +81-52-741-2111
- Recruiting
Niigata Cancer Center Hospital ( Site 1529)
Niigata, 951-8566
Study Coordinator, +81-25-266-5111
- Recruiting
Bell Land General Hospital ( Site 1509)
Sakai, Osaka, 599-8247
Study Coordinator, +81-72-234-2001
- Recruiting
Toho University Sakura Medical Center ( Site 1503)
Sakura, Chiba, 285-8741
Study Coordinator, +81-43-462-8811
- Recruiting
Sapporo Medical University Hospital ( Site 1501)
Sapporo, Hokkaido, 060-8543
Study Coordinator, +81-11-611-2111
- Recruiting
Hokkaido University Hospital ( Site 1500)
Sapporo, Hokkaido, 060-8648
Study Coordinator, +81-11-716-1161
- Active, not recruiting
Tokyo Women's Medical University ( Site 1505)
Shinjuku, Tokyo, 162-8666
- Recruiting
Tokushima University Hospital ( Site 1513)
Tokushima, 770-8503
Study Coordinator, +81-88-633-9294
- Recruiting
Ehime University Hospital ( Site 1514)
Tōon, Ehime, 791-0295
Study Coordinator, +81-89-964-5111
- Recruiting
Yamaguchi University Hospital ( Site 1522)
Ube, Yamaguchi, 755-8505
Study Coordinator, +81-836-22-2111
- Recruiting
Oita University Hospital ( Site 1521)
Yufu, Oita Prefecture, 879-5593
Study Coordinator, +81-97-549-4411
Germany13 sites, 13 recruiting
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0352)
Berlin, 10117
Study Coordinator, 4930450615285
- Recruiting
Studienzentrum Bayenthal Urologische Partnerschaft Koln ( Site 0365)
Cologne, North Rhine-Westphalia, 50968
Study Coordinator, +4917642771450
- Recruiting
Urologicum Duisburg ( Site 0361)
Duisburg, North Rhine-Westphalia, 47169
Study Coordinator, +4920360012919
- Recruiting
Universitätsklinikum Frankfurt Goethe-Universität ( Site 0354)
Frankfurt am Main, Hesse, 60590
Study Coordinator, +4969630180072
- Recruiting
Universitaetsklinik Hamburg-Eppendorf ( Site 0351)
Hamburg, 20246
Study Coordinator, +4915222815585
- Recruiting
Universitaetsklinikum Schleswig Holstein ( Site 0360)
Lübeck, Schleswig-Holstein, 23538
Study Coordinator, +49 451 500 43601
- Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0362)
Mainz, Rhineland-Palatinate, 55131
Study Coordinator, +49 6131 170
- Recruiting
Klinikum der Universität München Großhadern ( Site 0366)
Munich, Bavaria, 81377
Study Coordinator, 08944000
- Recruiting
klinikum rechts der isar der technischen universität münchen ( Site 0350)
Munich, Bavaria, 81675
Study Coordinator, 49 89 4140 2522
- Recruiting
Klinikum Nuernberg Nord ( Site 0353)
Nuremberg, Bavaria, 90419
Study Coordinator, +49 911 398 3085
- Recruiting
Studienpraxis Urologie ( Site 0358)
Nürtingen, Baden-Wurttemberg, 72622
Study Coordinator, 0049 15201622246
- Recruiting
LOGICURO GmbH ( Site 0364)
Potsdam, Brandenburg, 14482
Study Coordinator, +4933188769587
- Recruiting
Klinikum Stuttgart - Katharinenhospital ( Site 0355)
Stuttgart, Baden-Wurttemberg, 70174
Study Coordinator, +4971127854720
Netherlands13 sites, 13 recruiting
- Recruiting
Meander Medisch Centrum ( Site 0604)
Amersfoort, Utrecht, 3813 TZ
Study Coordinator, +3133850 7278
- Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0602)
Amsterdam, North Holland, 1066 CX
Study Coordinator, 003120512 9111
- Recruiting
Martini Ziekenhuis ( Site 0621)
Groningen, 9728 NT
Study Coordinator, 050-5246311
- Recruiting
Ziekenhuisgroep Twente, locatie Almelo ( Site 0615)
Hengelo, Overijssel, 7555 DL
Study Coordinator, +31887083782
- Recruiting
Tergooiziekenhuizen, locatie Hilversum ( Site 0619)
Hilversum, North Holland, 1212 VG
Study Coordinator, +31887535153
- Recruiting
Spaarne Gasthuis - Hoofddorp ( Site 0608)
Hoofddorp, North Holland, 2134 TM
Study Coordinator, +31232245802
- Recruiting
Maastricht UMC+ ( Site 0612)
Maastricht, Limburg, 6229 HX
Study Coordinator, 043-3877025
- Recruiting
UMC St. Radboud ( Site 0601)
Nijmegen, Gelderland, 6525 GA
Study Coordinator, 0031243610353
- Recruiting
Erasmus Medisch Centrum ( Site 0611)
Rotterdam, South Holland, 3015 GD
Study Coordinator, 0031107041906
- Recruiting
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 0600)
Schiedam, South Holland, 3118 JH
Study Coordinator, +31108931441
- Recruiting
Haga Ziekenhuis locatie Leyweg ( Site 0607)
The Hague, South Holland, 2545 AA
Study Coordinator, 070-210 2143
- Recruiting
St. Antonius Ziekenhuis, locatie Utrecht ( Site 0620)
Utrecht, 3543 AZ
Study Coordinator, +31883205148
- Recruiting
VieCuri Medisch Centrum, locatie Venlo ( Site 0610)
Venlo, Limburg, 5912 BL
Study Coordinator, 077-3205634
Spain11 sites, 11 recruiting
- Recruiting
Hospital del Mar ( Site 0822)
Barcelona, 08003
Study Coordinator, 34932483860
- Recruiting
Hospital Vall D Hebron ( Site 0814)
Barcelona, 08035
Study Coordinator, +34 93 4894374
- Recruiting
Hospital Universitario Reina Sofia ( Site 0816)
Córdoba, 14004
Study Coordinator, +34 957011464
- Recruiting
Hospital Lucus Augusti ( Site 0813)
Lugo, 27003
Study Coordinator, +343982296459
- Recruiting
Hospital General Universitario Gregorio Marañón ( Site 0812)
Madrid, Madrid, Comunidad de, 28009
Study Coordinator, +34 914269393
- Recruiting
Hospital Universitario Quiron Madrid ( Site 0823)
Madrid, 28223
Study Coordinator, +34914521987
- Recruiting
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0811)
Majadahonda Madrid, Madrid, 28220
Study Coordinator, +34911917418
- Recruiting
Hospital Universitario Marqués de Valdecilla ( Site 0810)
Santander, Cantabria, 39008
Study Coordinator, +34 +349422025155 25
- Recruiting
CHUS - Hospital Clinico Universitario ( Site 0815)
Santiago de Compostela, La Coruna, 15706
Study Coordinator, +34 663 609 134
- Recruiting
Hospital Universitario Virgen de Valme ( Site 0819)
Seville, 41014
Study Coordinator, +34955015273
- Recruiting
Fundación Instituto Valenciano de Oncología ( Site 0821)
Valencia, 46009
Study Coordinator, +34 96 111 42 29
France10 sites, 9 recruiting
- Completed
CHU Besançon ( Site 0305)
Besançon, Doubs, 25000
- Recruiting
Centre François Baclesse ( Site 0311)
Caen, Calvados, 14076
Study Coordinator, +33231455002
- Recruiting
Clinique Francois Chenieux ( Site 0312)
Limoges, Haute-Vienne, 87039
Study Coordinator, +33555454800
- Recruiting
Hôpital Privé Clairval ( Site 0303)
Marseille, Bouches-du-Rhone, 13273
Study Coordinator, +33496196230
- Recruiting
Centre Hospitalier Universitaire de Nîmes - Institut de Canc-Medical Oncology ( Site 0313)
Nîmes, Gard, 30029
Study Coordinator, +330466282491
- Recruiting
Hôpital Saint-Louis ( Site 0310)
Paris, Île-de-France Region, 75010
Study Coordinator, +33142494212
- Recruiting
CHU de Rouen ( Site 0301)
Rouen, Seine-Maritime, 76031
Study Coordinator, +33232881315
- Recruiting
Hopitaux Universitaires de Strasbourg- Hopital de Hautepierre ( Site 0314)
Strasbourg, Bas-Rhin, 67200
Study Coordinator, +33388116768
- Recruiting
Hôpital Foch ( Site 0309)
Suresnes, Ain, 92150
Study Coordinator, +33146253581
- Recruiting
Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 0307)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519
Study Coordinator, +33383598551
Argentina9 sites, 9 recruiting
- Recruiting
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
Berazategui, Buenos Aires, B1884BBF
Study Coordinator, +541142262013
- Recruiting
Centro Medico Dra De Salvo ( Site 0132)
CABA, C1426ABP
Study Coordinator, +5491151082017
- Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)
La Rioja, F5300COE
Study Coordinator, +543804693919
- Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)
Mar del Plata, Buenos Aires, B7600FZO
Study Coordinator, +5491132661847
- Recruiting
Instituto Alexander Fleming ( Site 0125)
Mar del Plata, Buenos Aires, C1426ANZ
Study Coordinator, +541132218900
- Recruiting
Centro Oncologico de Integracion Regional. COIR ( Site 0130)
Mendoza, M5500AYB
Study Coordinator, +542614252575
- Recruiting
Sanatorio Parque ( Site 0126)
Rosario, Santa Fe Province, S2000DSV
Study Coordinator, +543414200222
- Recruiting
Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)
Salta, A4400AWG
Study Coordinator, +5403874227282
- Recruiting
Instituto San Marcos ( Site 0137)
San Juan, J5400EBB
Study Coordinator, +5492645836798
Italy9 sites, 8 recruiting
- Recruiting
Azienda USL 8 di Arezzo ( Site 0503)
Arezzo, 52100
Study Coordinator, 0575255446
- Completed
Humanitas Gavazzeni ( Site 0508)
Bergamo, 24125
- Recruiting
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0510)
Foggia, 71122
Study Coordinator, 0881-736426
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0500)
Milan, Lombardy, 20133
Study Coordinator, (+39) 0223903028
- Recruiting
Istituto Nazionale Tumori Regina Elena ( Site 0507)
Rome, Roma, 00128
Study Coordinator, +390652666271
- Recruiting
Istituto Clinico Humanitas ( Site 0504)
Rozzano, Milano, 20089
Study Coordinator, (+39) 0282244061
- Recruiting
Azienda Ospedaliero Universitaria Senese ( Site 0505)
Siena, Tuscany, 53100
Study Coordinator, (+39) 0577586335
- Recruiting
Azienda Ospedaliera Santa Maria Terni ( Site 0509)
Terni, 05100
Study Coordinator, (+39) 0744205410
- Recruiting
Centro Ricerche Cliniche di Verona ( Site 0506)
Verona, 37134
Study Coordinator, 0458128120
United Kingdom8 sites, 7 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham ( Site 0923)
Birmingham, England, B15 2TH
Study Coordinator, +441216272000
- Recruiting
Addenbrooke's Hospital ( Site 0915)
Cambridge, Cambridgeshire, CB2 2QQ
Study Coordinator, +441223805000
- Recruiting
Torbay Hospital ( Site 0918)
Devon, United Kingdom, TQ2 7AA
Study Coordinator, +441803656615
- Active, not recruiting
Royal Devon & Exeter Hospital ( Site 0924)
Exeter, Devon, EX2 5DW
- Recruiting
University College London Hospital ( Site 0920)
London, Camden, NW1 2PG
Study Coordinator, +442034477729
- Recruiting
St Bartholomew s Hospital ( Site 0925)
London, London, City of, EC1A 7BE
Study Coordinator, 020 7377 7000
- Recruiting
Mount Vernon Hospital ( Site 0921)
Northwood, Hillingdon, HA6 2RN
Study Coordinator, 0203 826 2020
- Recruiting
Royal Marsden Hospital (Sutton) ( Site 0922)
Sutton, London, City of, SM2 5PT
Study Coordinator, +4402087224191
Colombia7 sites, 7 recruiting
- Recruiting
Centro Cancerológico del Caribe (CECAC) ( Site 0227)
Barranquilla, Atlántico, 080002
Study Coordinator, +573003263183
- Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0230)
Bogota, Cundinamarca, 110111
Study Coordinator, +57 3219198898
- Recruiting
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0229)
Bogotá, Bogota D.C., 111321
Study Coordinator, +57 3103469453
- Recruiting
Instituto Nacional De Cancerologia ( Site 0237)
Bogotá, Bogota D.C., 111511
Study Coordinator, +57 311 8083188
- Recruiting
Promotora Medica Las Americas S.A ( Site 0234)
Medellín, Antioquia, 050025
Study Coordinator, +573332779092
- Recruiting
Oncologos Del Occidente ( Site 0231)
Pereira, Risaralda Department, 660001
Study Coordinator, +576063310712
- Recruiting
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0228)
Valledupar, Cesar Department, 200001
Study Coordinator, +57 315 8505190
Israel7 sites, 7 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0462)
Haifa, 3109601
Study Coordinator, 04-7776234
- Recruiting
Shaare Zedek Medical Center ( Site 0468)
Jerusalem, 9103102
Study Coordinator, +97226555999
- Recruiting
Meir Medical Center ( Site 0464)
Kfar Saba, 4428164
Study Coordinator, 972-50-3745684
- Recruiting
Rabin Medical Center ( Site 0461)
Petah Tikva, 4941492
Study Coordinator, 972-3-9378074
- Recruiting
Sheba Medical Center ( Site 0460)
Ramat Gan, 5265601
Study Coordinator, 0544557539
- Recruiting
Sourasky Medical Center ( Site 0463)
Tel Aviv, 6423906
Study Coordinator, 03-6974907
- Recruiting
Yitzhak Shamir Medical Center. ( Site 0466)
Ẕerifin, 7033001
Study Coordinator, 972-8-9542196
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi ( Site 0906)
Adana, 01140
Study Coordinator, +905434352540
- Recruiting
Sakarya Egitim ve Arastırma Hastanesi ( Site 0897)
Adapazarı, Sakarya, 54290
Study Coordinator, 05523552411
- Recruiting
Hacettepe Universitesi Tip Fakultesi ( Site 0895)
Ankara, 06230
Study Coordinator, +90 5447363405
- Recruiting
Gazi University Health Research and Application Center Gazi Hospital ( Site 0903)
Ankara, 06560
Study Coordinator, 5064450149
- Recruiting
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0901)
Ankara, 06590
Study Coordinator, +905076255017
- Recruiting
Istanbul Universitesi Cerrahpasa ( Site 0896)
Istanbul, 34098
Study Coordinator, +9005348874207
- Recruiting
Konya Necmettin Erbakan Universitesi ( Site 0905)
Konya, 42080
Study Coordinator, +905340537685
Brazil6 sites, 6 recruiting
- Recruiting
Hospital Mario Penna ( Site 0179)
Belo Horizonte, Minas Gerais, 30380-472
Study Coordinator, +55 31 98803-2851
- Recruiting
Hospital Universitário Evangélico Mackenzie ( Site 0181)
Curitiba, Paraná, 80730-150
Study Coordinator, +5541991681411
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0184)
Porto Alegre, Rio Grande do Sul, 90020-090
Study Coordinator, +55 51 32148107
- Recruiting
Hospital de Base de São José do Rio Preto ( Site 0176)
São José do Rio Preto, São Paulo, 15090-000
Study Coordinator, +5517988053335
- Recruiting
IPITEC ( Site 0189)
São Paulo, 01221-020
Study Coordinator, +55 14 99776-3115
- Recruiting
IBCC - Núcleo de Pesquisa e Ensino ( Site 0183)
São Paulo, 04014-012
Study Coordinator, +551144500300
Mexico6 sites, 6 recruiting
- Recruiting
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0541)
Guadalajara, Jalisco, 44630
Study Coordinator, +52 3313587270
- Recruiting
Higiea Oncologia ( Site 0542)
Mexico City, Mexico City, 11810
Study Coordinator, 55 5273 1712
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0545)
Mexico City, Mexico City, 14080
Study Coordinator, +52 5554870900 2255
- Recruiting
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0540)
Monterrey, Nuevo León, 64460
Study Coordinator, 81 83338111 ext 1100
- Recruiting
Centro de Investigacion Clinica de Oaxaca ( Site 0543)
Oaxaca City, Oaxaca, 68020
Study Coordinator, 9516035559
- Recruiting
Grupo Ollin Care ( Site 0544)
Pachuca, Hidalgo, 42000
Study Coordinator, +52771715 752
Poland6 sites, 5 recruiting
- Recruiting
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 0696)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Study Coordinator, +48523743589
- Recruiting
Pratia Onkologia Katowice ( Site 0693)
Katowice, Silesian Voivodeship, 40-519
Study Coordinator, +48327462500
- Recruiting
Pratia MCM Krakow ( Site 0692)
Krakow, Lesser Poland Voivodeship, 30-727
Study Coordinator, +48122954100
- Completed
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0688)
Poznan, Greater Poland Voivodeship, 61-731
- Recruiting
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0686)
Siedlce, Masovian Voivodeship, 08-110
Study Coordinator, +48256403300
- Recruiting
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie ( Site 0685)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, +48225462331
South Korea6 sites, 6 recruiting
- Recruiting
Ulsan University Hospital ( Site 0793)
Donggu, Ulsan-Kwangyokshi, 44033
Study Coordinator, 82-52-230-1413
- Recruiting
Chonnam National University Hwasun Hospital ( Site 0794)
Hwasun Gun, Jeonranamdo, 58128
Study Coordinator, 82-61-379-7623
- Recruiting
The Catholic University of Korea St. Mary s Hospital ( Site 0795)
Seocho-gu, Seoul, 06591
Study Coordinator, 82-2-2258-6806
- Recruiting
Severance Hospital Yonsei University Health System ( Site 0790)
Seoul, 03722
Study Coordinator, 82-2-2228-8138
- Recruiting
Samsung Medical Center ( Site 0792)
Seoul, 06351
Study Coordinator, 82-2-3410-1767
- Recruiting
Asan Medical Center ( Site 0791)
Songpagu, Seoul, 05505
Study Coordinator, 82-2-3010-6961
Australia5 sites, 4 recruiting
- Recruiting
Blacktown Hospital ( Site 0154)
Blacktown, New South Wales, 2148
Study Coordinator, 61298818000
- Recruiting
Gallipoli Medical Research Ltd ( Site 0153)
Greenslopes, Queensland, 4120
Study Coordinator, +61402240196
- Completed
Macquarie University-MQ Health Clinical Trials Unit ( Site 0151)
Macquarie University, New South Wales, 2109
- Recruiting
Peter MacCallum Cancer Centre ( Site 0152)
Melbourne, Victoria, 3000
Study Coordinator, +61385595000
- Recruiting
Fiona Stanley Hospital ( Site 0155)
Murdock, Western Australia, 6150
Study Coordinator, +61861525886
Czechia5 sites, 5 recruiting
- Recruiting
Fakultni nemocnice u sv. Anny v Brne ( Site 0264)
Brno, Brno-mesto, 602 00
Study Coordinator, +420543182181
- Recruiting
Masarykuv onkologicky ustav ( Site 0260)
Brno, Brno-mesto, 656 53
Study Coordinator, +420543131111
- Recruiting
Fakultni nemocnice Olomouc ( Site 0262)
Olomouc, 779 00
Study Coordinator, +420585851111
- Recruiting
Fakultni nemocnice Ostrava ( Site 0263)
Ostrava - Poruba, Moravian-Silesian Region, 708 52
Study Coordinator, +420597371111
- Recruiting
Fakultni Nemocnice v Motole ( Site 0261)
Prague, Praha 5, 150 06
Study Coordinator, +420224431111
Greece5 sites, 4 recruiting
- Completed
Henry Dunant Hospital ( Site 0385)
Athens, Attica, 115 26
- Recruiting
Metropolitan General Hospital ( Site 0382)
Athens, Attica, 155 62
Study Coordinator, 0030 2106502831
- Recruiting
University General Hospital Attikon ( Site 0381)
Chaidari Athens, Attica, 124 62
Study Coordinator, +302105831000
- Recruiting
General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0384)
Kifissia, Attica, 145 64
Study Coordinator, +302103501500
- Recruiting
Athens Medical Center ( Site 0383)
Marousi, Attica, 151 25
Study Coordinator, +302106198100
Peru5 sites, 5 recruiting
- Recruiting
Unidad de Investigacion Oncologia Clínica Piura ( Site 0669)
Castilla, Piura, 20001
Study Coordinator, 51969618109
- Recruiting
Hospital Cayetano Heredia ( Site 0667)
Lima, 15012
Study Coordinator, 5112136000
- Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0666)
Lima, 15036
Study Coordinator, +5112241598
- Recruiting
Instituto Nacional de Enfermedades Neoplásicas ( Site 0665)
Lima, 15038
Study Coordinator, +5112016500
- Recruiting
Instituto Neuro Cardiovascular de las Americas ( Site 0668)
Lima, 15047
Study Coordinator, 51991366612
South Africa5 sites, 5 recruiting
- Recruiting
Cancercare Rondebosch Oncology ( Site 0771)
Cape Town, Gauteng, 7700
Study Coordinator, +27219443700
- Recruiting
Wits Clinical Research ( Site 0776)
Johannesburg, Gauteng, 2193
Study Coordinator, +27113390600
- Recruiting
Wilgers Oncology Centre ( Site 0775)
Pretoria, Gauteng, 0081
Study Coordinator, +27 83 441 4889
- Recruiting
Curo Oncology Centre ( Site 0779)
Pretoria, Gauteng, 0084
Study Coordinator, +27123356771
- Recruiting
LIFE GROENKLOOF ( Site 0777)
Pretoria, Gauteng, 0181
Study Coordinator, +27123466701
Switzerland5 sites, 5 recruiting
- Recruiting
Kantonspital Aarau ( Site 0857)
Aarau, Canton of Aargau, 5001
Study Coordinator, +41628386050
- Recruiting
University Hospital Basel ( Site 0859)
Basel, Canton of Basel-City, 4031
Study Coordinator, +41612655074
- Recruiting
HFR Fribourg - Hôpital Cantonal ( Site 0858)
Fribourg, 1708
Study Coordinator, +41263062260
- Recruiting
Hopitaux Universitaires de Geneve HUG. ( Site 0856)
Geneva, Canton of Geneva, 1211
Study Coordinator, +41223722901
- Recruiting
Stadtspital Zürich Triemli ( Site 0855)
Zurich, 8063
Study Coordinator, +41444163505
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg Universitetshospital, Syd ( Site 0293)
Aalborg, North Denmark, 9000
Study Coordinator, 97661400
- Recruiting
Herlev and Gentofte Hospital ( Site 0290)
Herlev, Capital Region, 2370
Study Coordinator, +4538683868
- Recruiting
Odense Universitetshospital ( Site 0294)
Odense, Region Syddanmark, 5000
Study Coordinator, +4566113333
- Recruiting
Vejle Sygehus ( Site 0291)
Vejle, Region Syddanmark, 7100
Study Coordinator, 79406060
Norway4 sites, 4 recruiting
- Recruiting
Sykehuset Innlandet HF Gjøvik ( Site 0652)
Gjøvik, Oppland, 2819
Study Coordinator, 004791506200
- Recruiting
Akershus Universitetssykehus-Onkologisk avdeling ( Site 0650)
Lorenskog, Akershus, 1474
Study Coordinator, 004767960000
- Recruiting
Oslo universitetssykehus, Radiumhospitalet ( Site 0653)
Oslo, 0379
Study Coordinator, +4722934000
- Recruiting
St. Olavs Hospital-Kreftklinikken ( Site 0651)
Trondheim, Sor-Trondelag, 7030
Study Coordinator, +4772825810
Sweden4 sites, 4 recruiting
- Recruiting
Skånes Universitetssjukhus Malmö ( Site 0841)
Malmö, Skåne County, 20502
Study Coordinator, 040331000
- Recruiting
Södersjukhuset ( Site 0844)
Stockholm, Stockholm County, 11883
Study Coordinator, +46812361000
- Recruiting
Karolinska Universitetssjukhuset Solna ( Site 0843)
Stockholm, Stockholm County, 171 64
Study Coordinator, 46812370000
- Recruiting
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 0840)
Uppsala, Östergötland County, 751 85
Study Coordinator, +46186110000
Taiwan4 sites, 4 recruiting
- Recruiting
Chang Gung Medical Foundation - Kaohsiung ( Site 0872)
Kaohsiung City, 83301
Study Coordinator, +88677317123x2270
- Recruiting
Taichung Veterans General Hospital ( Site 0873)
Taichung, 40705
Study Coordinator, +886423592525x5121
- Recruiting
Taipei Veterans General Hospital ( Site 0875)
Taipei, 11217
Study Coordinator, +88622871 2121
- Recruiting
National Taiwan University Hospital ( Site 0870)
Taiwan, Taipei, 10002
Study Coordinator, +88623123456
Austria3 sites, 3 recruiting
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)
Linz, Upper Austria, 4020
Study Coordinator, +4373276774724
- Recruiting
Uniklinikum Salzburg Universitaetsklinik für Innere Medizin III ( Site 0172)
Salzburg, 5020
Study Coordinator, +435725558858
- Recruiting
Klinikum Wels-Grieskirchen GmbH ( Site 0171)
Wels, Upper Austria, 4600
Study Coordinator, +4372424153452
Guatemala3 sites, 3 recruiting
- Recruiting
MEDI-K ( Site 0401)
Guatemala City, 01009
Study Coordinator, +502 22912323
- Recruiting
Med Clinic ( Site 0403)
Guatemala City, 01010
Study Coordinator, +502 41040976
- Recruiting
Onco Go ( Site 0402)
Guatemala City, 01010
Study Coordinator, +502 42140711
Ireland3 sites, 3 recruiting
- Recruiting
Cork University Hospital ( Site 0442)
Cork, T12 E8YV
Study Coordinator, +350214922687
- Recruiting
St Vincent's University Hospital ( Site 0441)
Dublin, Dublin, D04 T6F4
Study Coordinator, +4412214000
- Recruiting
Tallaght University Hospital ( Site 0440)
Dublin, D24 NR0A
Study Coordinator, +35314144299
Chile2 sites, 2 recruiting
- Recruiting
Fundación Arturo López Pérez ( Site 0201)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, 56224457398
- Recruiting
Bradfordhill ( Site 0200)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56229490970
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital ( Site 0415)
Hong Kong
Study Coordinator, +852 2255 3838
- Recruiting
Tuen Mun Hospital ( Site 0416)
New Territories
Study Coordinator, +852 2468 5111
Malaysia2 sites, 2 recruiting
- Recruiting
Sarawak General Hospital ( Site 0526)
Kuching, Sarawak, 93586
Study Coordinator, +6082276666
- Recruiting
Sunway Medical Centre ( Site 0529)
Petaling Jaya, Selangor, 47500
Study Coordinator, +60374919191
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore ( Site 0760)
Singapore, Central Singapore, 168583
Study Coordinator, +6564368000
- Recruiting
Tan Tock Seng Hospital ( Site 0761)
Singapore, Central Singapore, 308433
Study Coordinator, +6562566011
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 0885)
Bangkoknoi, Bangkok, 10700
Study Coordinator, +6624194488
- Recruiting
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0887)
Dusit, Bangkok, 10300
Study Coordinator, +6622443461
About this study
Official title: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
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.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- Ifinatamab deruxtecan, Docetaxel, Prednisone, Rescue Medication
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifinatamab deruxtecanDrug
Also called I-DXd, MK-2400, DS-7300a
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
DocetaxelDrug
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
PrednisoneDrug
Also called Prednisone acetate, Prednisolone, Prednisolone acetate
Oral tablet administered once per day or per approved product label
Rescue MedicationDrug
Also called 5-HT3 receptor antagonist, NK-1 receptor antagonist, Corticosteroid
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
| Study group | Role | What they receive |
|---|---|---|
| I-DXd | Experimental | Participants receive I-DXd 12mg/kg every 3 weeks (q3w) Receives: Drug: Ifinatamab deruxtecan; Drug: Rescue Medication |
| Docetaxel | Active comparator | Participants receive docetaxel 75 mg/m^2 q3w and prednisone 10 mg/day or per approved product label Receives: Drug: Docetaxel; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 36 months
Radiographic Progression Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Secondary outcomes (9)
Time to First Subsequent Therapy (TFST)
TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Measured: Up to approximately 36 months
Objective Response Rate (ORR)
The ORR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR.
Measured: Up to approximately 36 months
Duration of Response (DOR)
For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Time to Pain Progression (TTPP)
TTPP is defined as the time from randomization to pain progression based on the brief pain inventory-short form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score).
Measured: Up to approximately 36 months
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is defined as the first date that 1) ≥25% increase and ≥2 ng/mL above the nadir which is confirmed by a second value≥3 weeks later if there is PSA decline from baseline, 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Measured: Up to approximately 36 months
PSA Response Rate
PSA response rate is defined as the proportion of participants in the analysis population who have a PSA reduction of ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG criteria.
Measured: Up to approximately 36 months
Time to First Symptomatic Skeletal-Related Event (SSRE)
Time to first SSRE is defined as the time from randomization to the first occurrence of any of the following symptomatic skeletal-related events:
- use of EBRT to prevent or relieve skeletal symptoms,
- new symptomatic pathologic bone fracture (vertebral or non-vertebral),
- spinal cord compression,
- a tumor-related orthopedic surgical intervention.
Measured: Up to approximately 36 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 36 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start13 May 2025
- Primary completion26 Jun 2028 (estimated)
- Study completion6 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925737
- Sponsor's protocol ID
- 2400-001
- Other IDs
- U1111-1312-2498, 2024-517423-40-00, MK-2400-001
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf