Trial Title:
A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
NCT ID:
NCT06356311
Condition:
Gastroesophageal Cancer
Conditions: Official terms:
Adenocarcinoma
Trifluridine
Paclitaxel
Docetaxel
Irinotecan
Conditions: Keywords:
Gastroesophageal cancer
Gastroesophageal adenocarcinoma
Gastric adenocarcinoma
Esophageal adenocarcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Sacituzumab tirumotecan
Description:
Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15,
and 29 of every 42-day cycle.
Arm group label:
Sacituzumab tirumotecan
Other name:
SKB264. MK-2870
Intervention type:
Drug
Intervention name:
Trifluridine-Tipiracil
Description:
Trifluridine-tipiracil will be administered at 35 mg/m^2 as tablet orally twice a day on
days 1-5 and 8-12 of every 28-day cycle.
Arm group label:
Treatment of Physician's Choice (TPC)
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Irinotecan will be administered at a dose of 150 mg/m^2 by IV infusion on days 1 and 15
of every 28-day cycle.
Arm group label:
Treatment of Physician's Choice (TPC)
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel will be administered at a dose of 80 mg/m^2 by IV infusion on days 1, 8 and 15
of every 28-day cycle.
Arm group label:
Treatment of Physician's Choice (TPC)
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel will be administered at a dose of 75 mg/m^2 by IV infusion on day 1 of a 21-day
cycle.
Arm group label:
Treatment of Physician's Choice (TPC)
Intervention type:
Drug
Intervention name:
Rescue medication
Description:
Participants are allowed to take rescue medication for stomatitis or oral mucositis. At
the discretion of the investigator, participants are provided with a prescription for
rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2)
receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or
steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin
suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and
non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth
factors.
Arm group label:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
Supportive care measures
Description:
Participants are allowed to take supportive care measures for the management of adverse
events associated with study intervention at the discretion of the investigator.
Supportive care measures may include but are not limited to antidiarrheal agents,
antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and
granulocyte and erythroid growth factors.
Arm group label:
Sacituzumab tirumotecan
Arm group label:
Treatment of Physician's Choice (TPC)
Summary:
This study will compare how safe and effective sacituzumab tirumotecan is versus the
treatment of physician's choice (TPC) in participants with advanced/metastatic
gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab
tirumotecan is superior to TPC with respect to Overall Survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has a histologically-or cytologically-confirmed diagnosis of advanced, unresectable
or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or
esophageal adenocarcinoma
- Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy
regimens
- Participants are eligible regardless of human epidermal growth factor receptor-2
(HER2) status. Participants who are HER2+ must have previously received trastuzumab
where available/appropriate
- Has adequate organ function
- Has provided tumor tissue sample for determination of trophoblast cell-surface
antigen 2 (TROP2) status by the central laboratory before randomization for
stratification
- Participants who have AEs due to previous anticancer therapies must have recovered
to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with
endocrine related AEs who are adequately treated with hormone replacement therapy
are eligible
- Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
as assessed by the local site investigator/radiology
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3
days before randomization
- Has ability to swallow oral medication for those who may receive
trifluridine-tipiracil
- Human immunodeficiency virus (HIV) infected participants must have well-controlled
HIV on antiretroviral therapy (ART)
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have
received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral
load
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable
Exclusion Criteria:
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease
and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has Grade ≥2 peripheral neuropathy
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative
colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease,
including New York Heart Association Class III or IV congestive heart failure,
unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia,
prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious
cardiovascular and cerebrovascular diseases within 6 months before the first dose of
study intervention
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or
diuretic drugs within 2 weeks before the first dose of study intervention
- Has received prior treatment with a trophoblast antigen 2(TROP2) targeted
antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor based, and/or a
topoisomerase 1 inhibitor-based chemotherapy.
- Has received prior systemic anticancer therapy within 2 weeks before the first dose
of study intervention
- Has received prior radiotherapy within 2 weeks before the first dose of study
intervention, has radiation-related toxicities, requiring corticosteroids, and/or
has had radiation pneumonitis
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention
- Is currently receiving a strong and/or moderate inducer/inhibitor of cytochrome P450
3A4 (CYP3A4) that cannot be discontinued for the duration of treatment with study
intervention. The required washout period before starting study intervention is 2
weeks
- Has received an investigational agent or has used an investigational device within 4
weeks before the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has an active infection requiring systemic therapy
- HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castlemans's Disease
- Has concurrent active hepatitis B (defined as hepatitis B surface antigen (HBsAg)
positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus
(HCV) defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid
(RNA)) infection
- Has had major surgery or significant traumatic injury within 4 weeks before the
first dose of study intervention. Anticipation of the need for major surgery during
the course of treatment with study intervention is also exclusionary
- Has severe hypersensitivity (Grades >=3) to sacituzumab tirumotecan (MK-2870), any
of its excipients, and/or to another biologic therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center ( Site 0119)
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
480-256-6444
Facility:
Name:
UCLA Hematology/Oncology - Santa Monica ( Site 0140)
Address:
City:
Los Angeles
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
310-829-5471
Facility:
Name:
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
407-303-5826
Facility:
Name:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
770-281-5100
Facility:
Name:
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
859-257-4488
Facility:
Name:
The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Si
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
502-562-4673
Facility:
Name:
Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)
Address:
City:
Louisville
Zip:
40217
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
502-636-7845
Facility:
Name:
The West Clinic, PLLC dba West Cancer Center ( Site 0110)
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
901-683-0055
Facility:
Name:
Inova Schar Cancer Institute ( Site 0106)
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
571-472-4724
Facility:
Name:
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+3227641041
Facility:
Name:
UZ Leuven-Digestive Oncology ( Site 1000)
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3216344225
Facility:
Name:
AZ Delta vzw ( Site 1002)
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+3251237215
Facility:
Name:
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406)
Address:
City:
Natal
Zip:
59075-740
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
55 84 991191032
Facility:
Name:
Hospital de Caridade de Ijuí ( Site 0412)
Address:
City:
Ijui
Zip:
98700 000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
55 984012329
Facility:
Name:
Centro de Hematologia e Oncologia ( Site 0404)
Address:
City:
Joinville
Zip:
89202-050
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
554734331849
Facility:
Name:
A. C. Camargo Cancer Center ( Site 0409)
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
551121895138
Facility:
Name:
IBCC - Núcleo de Pesquisa e Ensino ( Site 0402)
Address:
City:
Sao Paulo
Zip:
04014-002
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
551144500360
Facility:
Name:
McGill University Health Centre ( Site 0201)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
514-934-1934 ext 45721
Facility:
Name:
James Lind Centro de Investigacion del Cancer ( Site 0506)
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56994443272
Facility:
Name:
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503)
Address:
City:
Santiago
Zip:
7500653
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56991612199
Facility:
Name:
FALP-UIDO ( Site 0500)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502)
Address:
City:
Santiago
Zip:
7620002
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56991290140
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0501)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56981350156
Facility:
Name:
Anhui Provincial Cancer Hospital-medical oncology ( Site 3016)
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13866175691
Facility:
Name:
Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038)
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13865952007
Facility:
Name:
Chongqing University Three Gorges Hospital ( Site 3036)
Address:
City:
Wanzhou
Zip:
404000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613983531750
Facility:
Name:
Sun Yatsen University Cancer Center ( Site 3001)
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13922206676
Facility:
Name:
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019)
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13826259986
Facility:
Name:
Cancer Hospital of Shantou University Medical College ( Site 3034)
Address:
City:
Shantou
Zip:
515041
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18565052277
Facility:
Name:
Fourth Hospital of Hebei Medical University ( Site 3015)
Address:
City:
Shijiazhuang
Zip:
050035
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613831120299
Facility:
Name:
Hubei Cancer Hospital ( Site 3012)
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613995607152
Facility:
Name:
LinYi Cancer Hospital-Gastrology department ( Site 3024)
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13869908100
Facility:
Name:
Sichuan Cancer hospital ( Site 3030)
Address:
City:
Chengdu
Zip:
610213
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
18908190029
Facility:
Name:
Nanchong Central Hospital (Jiangdong Campus) ( Site 3029)
Address:
City:
Nanchong
Zip:
637199
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86-13890402880
Facility:
Name:
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006)
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13331930446
Facility:
Name:
Taizhou Hospital of Zhejiang Province ( Site 3020)
Address:
City:
Linhai
Zip:
317000
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13515861286
Facility:
Name:
Rigshospitalet ( Site 1102)
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4535458471
Facility:
Name:
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103)
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4597666795
Facility:
Name:
Odense Universitetshospital-Department of oncology ( Site 1101)
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4565411590
Facility:
Name:
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211)
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+33681078205
Facility:
Name:
Centre François Baclesse ( Site 1202)
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33231455002
Facility:
Name:
CHU Rangueil-Digestive oncology department ( Site 1210)
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33561322142
Facility:
Name:
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203)
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33299253196
Facility:
Name:
Centre Oscar Lambret ( Site 1206)
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33320295935
Facility:
Name:
CENTRE LEON BERARD-Medical oncology ( Site 1208)
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+33 4 78 78 59 92
Facility:
Name:
Centre Hospitalier Universitaire de Poitiers ( Site 1209)
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33549444951
Facility:
Name:
NCT-Department of Medical Oncology ( Site 1302)
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+496221566857
Facility:
Name:
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300)
Address:
City:
Hamburg
Zip:
20249
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+49403603522-0
Facility:
Name:
Queen Mary Hospital ( Site 3100)
Address:
City:
Hksar
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
85291259586
Facility:
Name:
Prince of Wales Hospital ( Site 3102)
Address:
City:
Shatin
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
85235051042
Facility:
Name:
Queen Elizabeth Hospital ( Site 3101)
Address:
City:
Yau Ma Tei
Zip:
999077
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
85235067393
Facility:
Name:
Hillel Yaffe Medical Center ( Site 1604)
Address:
City:
Hadera
Zip:
3810101
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97247776745
Facility:
Name:
Rambam Health Care Campus-Oncology Division ( Site 1600)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+97247776700
Facility:
Name:
Hadassah Medical Center ( Site 1603)
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97226777957
Facility:
Name:
Rabin Medical Center ( Site 1605)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972522902160
Facility:
Name:
Sourasky Medical Center ( Site 1602)
Address:
City:
Tel Aviv
Zip:
64239
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97236973082
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703)
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390458128116
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700)
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390223903807
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana ( Site 1702)
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
39050992454
Facility:
Name:
Ospedale San Raffaele-Oncologia Medica ( Site 1701)
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+393400005069
Facility:
Name:
National Cancer Center Hospital East ( Site 3300)
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-4-7133-1111
Facility:
Name:
Kochi Medical School Hospital ( Site 3304)
Address:
City:
Nankoku
Zip:
783-8505
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-88-866-5811
Facility:
Name:
Saitama Prefectural Cancer Center ( Site 3302)
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-48-722-1111
Facility:
Name:
National Cancer Center Hospital ( Site 3301)
Address:
City:
Chuo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-3-3542-2511
Facility:
Name:
The Cancer Institute Hospital of JFCR ( Site 3306)
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-3-3520-0111
Facility:
Name:
National Hospital Organization Kyushu Cancer Center ( Site 3303)
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-92-541-3231
Facility:
Name:
Seoul National University Bundang Hospital ( Site 3504)
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821041671676
Facility:
Name:
Seoul National University Hospital-Oncology ( Site 3503)
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82220720701
Facility:
Name:
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500)
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82222288050
Facility:
Name:
Asan Medical Center-Department of Oncology ( Site 3501)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230105935
Facility:
Name:
Samsung Medical Center-Division of Hematology/Oncology ( Site 3502)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82-2-3410-6820
Facility:
Name:
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505)
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
01090566116
Facility:
Name:
Hospital Pulau Pinang ( Site 3403)
Address:
City:
George Town
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
01641569261
Facility:
Name:
Sarawak General Hospital-Radiotherapy Unit ( Site 3401)
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0124465010
Facility:
Name:
National Cancer Institute-Radiotherapy and Oncology ( Site 3404)
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0123225084
Facility:
Name:
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408)
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+60126061210
Facility:
Name:
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904)
Address:
City:
Concepcion
Zip:
12125
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+51983582526
Facility:
Name:
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905)
Address:
City:
Lima
Zip:
15036
Country:
Peru
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
51951881870
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
52 374 35 89
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
Address:
City:
Warszawa
Zip:
02-034
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
225709223
Facility:
Name:
Bialostockie Centrum Onkologii ( Site 1804)
Address:
City:
Bialystok
Zip:
15-027
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48604988923
Facility:
Name:
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej " Profil Jednego Dnia " ( Site 1810)
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
58 72 60 964
Facility:
Name:
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811)
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48 504957307
Facility:
Name:
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1801)
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
94 34 88 930
Facility:
Name:
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902)
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34985108000
Facility:
Name:
Hospital Universitario Marqués de Valdecilla ( Site 1901)
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34 654557483
Facility:
Name:
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905)
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34 981178000 291477
Facility:
Name:
COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904)
Address:
City:
Pamplona
Zip:
31009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0034 848422222
Facility:
Name:
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34932746085
Facility:
Name:
Hospital Clinico San Carlos ( Site 1903)
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
349133030007545
Facility:
Name:
Ninewells Hospital and Medical School-Oncology Petty ( Site 2209)
Address:
City:
Dundee
Zip:
DD2 1SG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
441382496685
Facility:
Name:
St Bartholomew's Hospital ( Site 2206)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
07985955179
Facility:
Name:
The Christie NHS Foundation Trust-Medical Oncology ( Site 2201)
Address:
City:
Manchester
Zip:
m20 4bx
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
447710630514
Start date:
May 3, 2024
Completion date:
May 5, 2028
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356311
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2870-015&kw=2870-015
