Trial Title:
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
NCT ID:
NCT05226598
Condition:
Metastatic Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab/Vibostolimab
Description:
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as
IV infusion for up to 35 administrations
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
MK-7684A
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
PARAPLATIN®, Paraplatin NovaPlus ®
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
Platinol-AQ®
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
TAXOL®, ONXOL®
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day
cycle for 4 administrations
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
ABRAXANE®
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable
adverse event (AE), or participant or physician decision
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm group label:
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
Alimta®
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations
Arm group label:
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Other name:
MK-3475, KEYTRUDA®
Summary:
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with
chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect
to overall survival (OS) in treatment-naïve metastatic participants with non-small cell
lung cancer (NSCLC).
Criteria for eligibility:
Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- A histologically or cytologically confirmed diagnosis of Stage IV squamous or
non-squamous NSCLC
- Has not received prior systemic treatment for metastatic NSCLC
- Has measurable disease based on RECIST 1.1, as determined by the local site
assessment
- Has a life expectancy of at least 3 months
- Males: Use contraception unless confirmed to be azoospermic; Females: Women of
childbearing potential use highly effective contraceptive method
Exclusion Criteria:
- Known additional malignancy that is progressing or has required active treatment
within the past 3 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy
components, and/or any of its excipients
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days before the first dose of study medication
- Active autoimmune disease that has required systemic treatment in past 2 years,
except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and
Hepatitis C virus
- Received prior systemic anticancer therapy for metastatic disease
- Received a live or live attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed
- History of allogeneic tissue/solid organ transplant
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs
(NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period
for long-acting agents, such as piroxicam)
- Is unable or unwilling to take folic acid or vitamin B12 supplementation
- Currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks before the first dose of
study intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCHealth Memorial Hospital-Heme Onc ( Site 0003)
Address:
City:
Colorado Springs
Zip:
80909
Country:
United States
Facility:
Name:
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Facility:
Name:
Mayo Clinic in Florida ( Site 0022)
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
Mount Sinai Hospital ( Site 0011)
Address:
City:
Chicago
Zip:
60608
Country:
United States
Facility:
Name:
University of Chicago Medical Center ( Site 0015)
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
New England Cancer Specialists ( Site 0008)
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Facility:
Name:
Cancer and Hematology Centers of Western Michigan ( Site 0002)
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Facility:
Name:
Mayo Clinic in Rochester, Minnesota ( Site 0030)
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Stony Brook University-Cancer Center ( Site 0013)
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Facility:
Name:
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
Address:
City:
Lancaster
Zip:
17604
Country:
United States
Facility:
Name:
Charleston Oncology ( Site 0019)
Address:
City:
Charleston
Zip:
29414
Country:
United States
Facility:
Name:
University of Virginia Cancer Center ( Site 0018)
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Facility:
Name:
Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
Address:
City:
Berazategui
Zip:
B1884BBF
Country:
Argentina
Facility:
Name:
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
Address:
City:
Mar del Plata
Zip:
B7600FZO
Country:
Argentina
Facility:
Name:
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
Address:
City:
ABB
Zip:
C1199ABB
Country:
Argentina
Facility:
Name:
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
Address:
City:
Buenos Aires
Zip:
C1431FWO
Country:
Argentina
Facility:
Name:
Sanatorio Parque ( Site 0205)
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Facility:
Name:
Hospital Provincial del Centenario ( Site 0212)
Address:
City:
Rosario
Zip:
2002
Country:
Argentina
Facility:
Name:
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Facility:
Name:
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
Address:
City:
Linz
Zip:
4020
Country:
Austria
Facility:
Name:
Kepler Universitätsklinikum ( Site 0707)
Address:
City:
Linz
Zip:
4021
Country:
Austria
Facility:
Name:
Medizinische Universität Graz ( Site 0704)
Address:
City:
Graz
Zip:
8036
Country:
Austria
Facility:
Name:
Medizinische Universitaet Innsbruck ( Site 0703)
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Facility:
Name:
Klinik Penzing-2. Lungenabteilung ( Site 0702)
Address:
City:
Vienna
Zip:
1140
Country:
Austria
Facility:
Name:
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
Address:
City:
Wien
Zip:
1210
Country:
Austria
Facility:
Name:
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
Address:
City:
Natal
Zip:
59075-740
Country:
Brazil
Facility:
Name:
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
Address:
City:
Porto Alegre
Zip:
91350-200
Country:
Brazil
Facility:
Name:
Clínica de Oncologia Reichow ( Site 0407)
Address:
City:
Blumenau
Zip:
89010-340
Country:
Brazil
Facility:
Name:
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Facility:
Name:
Hospital Paulistano ( Site 0401)
Address:
City:
Sao Paulo
Zip:
01321-001
Country:
Brazil
Facility:
Name:
James Lind Centro de Investigación del Cáncer ( Site 0502)
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Facility:
Name:
CIDO SpA-Oncology ( Site 0508)
Address:
City:
Temuco
Zip:
4810148
Country:
Chile
Facility:
Name:
Biocenter ( Site 0514)
Address:
City:
Concepción
Zip:
4070196
Country:
Chile
Facility:
Name:
FALP-UIDO ( Site 0505)
Address:
City:
Santiago
Zip:
6900941
Country:
Chile
Facility:
Name:
Centro de Oncología de Precisión ( Site 0515)
Address:
City:
Santiago
Zip:
7560908
Country:
Chile
Facility:
Name:
Bradfordhill ( Site 0510)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Facility:
Name:
ONCOCENTRO APYS-ACEREY ( Site 0503)
Address:
City:
Viña del Mar
Zip:
2520598
Country:
Chile
Facility:
Name:
Centro de Investigación Oncológica del Norte ( Site 0504)
Address:
City:
Antofagasta
Zip:
1240000
Country:
Chile
Facility:
Name:
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
Address:
City:
Hefei
Zip:
230036
Country:
China
Facility:
Name:
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
The First Affiliated hospital of Xiamen University ( Site 2626)
Address:
City:
Xiamen City
Zip:
361003
Country:
China
Facility:
Name:
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Facility:
Name:
Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
Address:
City:
Harbin
Zip:
150000
Country:
China
Facility:
Name:
Henan Cancer Hospital ( Site 2608)
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Facility:
Name:
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Xiangya Hospital Central South University-Oncology department ( Site 2627)
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
The Second Xiangya Hospital of Central South University ( Site 2623)
Address:
City:
Changsha
Zip:
410011
Country:
China
Facility:
Name:
Hunan Cancer Hospital ( Site 2622)
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
Address:
City:
Nanjing
Zip:
210000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Jilin Cancer Hospital-oncology department ( Site 2603)
Address:
City:
Changchun
Zip:
132000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
Shandong Cancer Hospital-Oncology Department ( Site 2630)
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center ( Site 2616)
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
Address:
City:
Shanghai
Zip:
200433
Country:
China
Facility:
Name:
West China Hospital of Sichuan University ( Site 2610)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Facility:
Name:
Sichuan Cancer hospital ( Site 2628)
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
The Second People's Hospital of Yibin ( Site 2629)
Address:
City:
Yibin
Zip:
644000
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
Address:
City:
Tianjin
Zip:
300060
Country:
China
Facility:
Name:
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital-Oncology ( Site 2612)
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Facility:
Name:
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
Address:
City:
Hangzhou
Zip:
310052
Country:
China
Facility:
Name:
Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
Address:
City:
Medellin
Zip:
050030
Country:
Colombia
Facility:
Name:
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
Address:
City:
Valledupar
Zip:
200001
Country:
Colombia
Facility:
Name:
Oncomedica S.A.-Oncomedica S.A ( Site 0609)
Address:
City:
Montería
Zip:
230001
Country:
Colombia
Facility:
Name:
Administradora Country S.A. - Clinica del Country ( Site 0601)
Address:
City:
Bogotá
Zip:
110221
Country:
Colombia
Facility:
Name:
Oncologos del Occidente ( Site 0608)
Address:
City:
Pereira
Zip:
660001
Country:
Colombia
Facility:
Name:
CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
Address:
City:
Orléans
Zip:
45067
Country:
France
Facility:
Name:
Centre Hospitalier d'Annecy ( Site 0807)
Address:
City:
Epagny Metz-Tessy
Zip:
74370
Country:
France
Facility:
Name:
Institut de Cancérologie de l'Ouest ( Site 0802)
Address:
City:
ANGERS cedex 02
Zip:
49055
Country:
France
Facility:
Name:
Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
Address:
City:
Lille
Zip:
59037
Country:
France
Facility:
Name:
CENTRE LEON BERARD ( Site 0803)
Address:
City:
Lyon CEDEX 08
Zip:
69373
Country:
France
Facility:
Name:
HIA Sainte Anne ( Site 0804)
Address:
City:
Toulon
Zip:
83800 Cedex 9
Country:
France
Facility:
Name:
Centre Hospitalier d'Avignon ( Site 0810)
Address:
City:
Avignon
Zip:
84000
Country:
France
Facility:
Name:
UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Facility:
Name:
GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
Address:
City:
Dortmund
Zip:
44263
Country:
Germany
Facility:
Name:
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
Address:
City:
Lübeck
Zip:
23538
Country:
Germany
Facility:
Name:
SRH Wald-Klinikum Gera ( Site 0911)
Address:
City:
Gera
Zip:
07548
Country:
Germany
Facility:
Name:
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Facility:
Name:
Rambam Health Care Campus-Oncology ( Site 1303)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Facility:
Name:
Shaare Zedek Medical Center-Oncology ( Site 1306)
Address:
City:
Jerusalem
Zip:
9013102
Country:
Israel
Facility:
Name:
Meir Medical Center-oncology ( Site 1301)
Address:
City:
Kfar Saba
Zip:
4428164
Country:
Israel
Facility:
Name:
Sheba Medical Center-ONCOLOGY ( Site 1302)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Facility:
Name:
Sourasky Medical Center-Oncology ( Site 1305)
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Facility:
Name:
National Hospital Organization Shikoku Cancer Center ( Site 2414)
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Facility:
Name:
Ehime University Hospital ( Site 2411)
Address:
City:
Toon
Zip:
791-0295
Country:
Japan
Facility:
Name:
Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
Address:
City:
Akashi
Zip:
673-8558
Country:
Japan
Facility:
Name:
Kanazawa University Hospital ( Site 2407)
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Facility:
Name:
Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Facility:
Name:
Miyagi Cancer Center ( Site 2401)
Address:
City:
Natori
Zip:
981-1293
Country:
Japan
Facility:
Name:
Kansai Medical University Hospital ( Site 2415)
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Facility:
Name:
Saitama Prefectural Cancer Center ( Site 2406)
Address:
City:
Ina-machi
Zip:
362-0806
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center ( Site 2408)
Address:
City:
Nagaizumi
Zip:
411-8777
Country:
Japan
Facility:
Name:
Japanese Foundation for Cancer Research ( Site 2402)
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Facility:
Name:
Showa University Hospital ( Site 2403)
Address:
City:
Shinagawa
Zip:
1428666
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Medical Center ( Site 2413)
Address:
City:
Fukuoka
Zip:
810-8563
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Cancer Center ( Site 2412)
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Facility:
Name:
Okayama University Hospital ( Site 2410)
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Facility:
Name:
Nippon Medical School Hospital ( Site 2404)
Address:
City:
Tokyo
Zip:
113-8603
Country:
Japan
Facility:
Name:
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Facility:
Name:
Pusan National University Hospital ( Site 2205)
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center ( Site 2206)
Address:
City:
Songpa-gu
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
Address:
City:
Deagu
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
Address:
City:
Daejeon
Zip:
35015
Country:
Korea, Republic of
Facility:
Name:
Korea University Guro Hospital-Internal Medicine ( Site 2204)
Address:
City:
Seoul
Country:
Korea, Republic of
Facility:
Name:
CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
Address:
City:
Saltillo
Zip:
25279
Country:
Mexico
Facility:
Name:
Alivia Clínica de Alta Especialidad ( Site 0310)
Address:
City:
Ciudad de Mexico
Zip:
06760
Country:
Mexico
Facility:
Name:
Arké SMO S.A. de C.V. ( Site 0301)
Address:
City:
Mexico
Zip:
06700
Country:
Mexico
Facility:
Name:
Hospital Civil Fray Antonio Alcalde ( Site 0307)
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Facility:
Name:
Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
Address:
City:
Warsaw
Zip:
04-125
Country:
Poland
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Facility:
Name:
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Facility:
Name:
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
Address:
City:
Prabuty
Zip:
82-550
Country:
Poland
Facility:
Name:
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
Address:
City:
Bystra
Zip:
43-360
Country:
Poland
Facility:
Name:
Przychodnia Lekarska KOMED ( Site 1902)
Address:
City:
Konin
Zip:
62-500
Country:
Poland
Facility:
Name:
Med-Polonia Sp. z o. o. ( Site 1909)
Address:
City:
Poznan
Zip:
60-693
Country:
Poland
Facility:
Name:
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Facility:
Name:
Hospital Insular de Gran Canaria-Oncology ( Site 1102)
Address:
City:
Las Palmas de Gran Canaria
Zip:
35001
Country:
Spain
Facility:
Name:
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital Clinico San Carlos-Oncology Department ( Site 1107)
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Facility:
Name:
Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Facility:
Name:
China Medical University Hospital ( Site 2253)
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Facility:
Name:
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital-Oncology ( Site 2255)
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Facility:
Name:
Faculty of Medicine - Khon Kaen University ( Site 2303)
Address:
City:
Muang
Zip:
40002
Country:
Thailand
Facility:
Name:
Faculty of Medicine Siriraj Hospital ( Site 2304)
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Facility:
Name:
Chulabhorn Hospital ( Site 2305)
Address:
City:
Lak Si
Zip:
10210
Country:
Thailand
Facility:
Name:
Songklanagarind hospital ( Site 2302)
Address:
City:
Hatyai
Zip:
90110
Country:
Thailand
Facility:
Name:
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Facility:
Name:
Acibadem Altunizade Hospital-Oncology ( Site 1207)
Address:
City:
Üsküdar / Stanbul
Zip:
34662
Country:
Turkey
Facility:
Name:
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
Address:
City:
Adana
Zip:
01250
Country:
Turkey
Facility:
Name:
Hacettepe Universitesi-oncology hospital ( Site 1202)
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Facility:
Name:
Liv Hospital Ankara-Oncology ( Site 1205)
Address:
City:
Ankara
Zip:
06680
Country:
Turkey
Facility:
Name:
Ankara City Hospital ( Site 1204)
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Trakya University-Medical Oncology ( Site 1203)
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Facility:
Name:
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Facility:
Name:
Umraniye Training and Research Hospital-medical oncology ( Site 1206)
Address:
City:
Istanbul
Zip:
34766
Country:
Turkey
Facility:
Name:
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
Address:
City:
Leicester
Country:
United Kingdom
Facility:
Name:
Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Facility:
Name:
University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
Address:
City:
London-Camden
Zip:
NW1 2PG
Country:
United Kingdom
Facility:
Name:
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Start date:
March 24, 2022
Completion date:
September 27, 2027
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/NCT05226598
https://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7684A-007&kw=7684A-007