A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

PHASE3CompletedINTERVENTIONAL
Enrollment

441

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

August 15, 2024

Study Completion Date

February 21, 2025

Conditions
Colorectal Cancer
Interventions
BIOLOGICAL

favezelimab/pembrolizumab

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

DRUG

regorafenib

Oral

DRUG

TAS-102

Oral

Trial Locations (152)

333

Chang Gung Medical Foundation. Linkou ( Site 0952), Taoyuan District

704

National Cheng Kung University Hospital ( Site 0955), Tainan City

833

Chang Gung Medical Foundation - Kaohsiung ( Site 0956), Kaohsiung City

1478

Akershus universitetssykehus ( Site 1352), Loerenskog

2145

Westmead Hospital ( Site 0057), Westmead

2196

Sandton Oncology Medical Group PTY LTD ( Site 1501), Sandton

3021

Western Health-Sunshine & Footscray Hospitals ( Site 0052), St Albans

3199

Frankston Hospital ( Site 0056), Frankston

4029

Royal Brisbane and Women s Hospital ( Site 0058), Herston

5011

Queen Elizabeth Hospital ( Site 0050), Woodville South

5053

Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353), Bergen

6008

St John of God Subiaco Hospital ( Site 0051), Perth

6045

Cancer Care Langenhoven Drive Oncology Centre ( Site 1504), Port Elizabeth

7030

St Olavs Hospital ( Site 1354), Trondheim

7570

Cape Town Oncology Trials Pty Ltd ( Site 1506), Kraaifontein

7700

Cancercare Rondebosch Oncology ( Site 1509), Rondebosch

9019

Universitetssykehuset i Nord Norge. ( Site 1355), Tromsø

10048

National Taiwan University Hospital ( Site 0950), Taipei

10065

Memorial Sloan Kettering Cancer Center ( Site 1703), New York

11217

Taipei Veterans General Hospital ( Site 0951), Taipei

20007

Georgetown University Hospital ( Site 1148), Washington D.C.

20016

Sibley Memorial Hospital ( Site 1143), Washington D.C.

20089

Istituto Clinico Humanitas - Cancer Center ( Site 0555), Rozzano

20162

ASST Grande Ospedale Metropolitano Niguarda ( Site 0550), Milan

22031

Inova Schar Cancer Institute ( Site 1130), Fairfax

22087

Katholisches Marienkrankenhaus gGmbH ( Site 1257), Hamburg

23219

VCU Health Adult Outpatient Pavillion ( Site 1712), Richmond

24014

Blue Ridge Cancer Care ( Site 1718), Roanoke

25011

Ukrainian Center of Tomotherapy ( Site 1658), Kropyvnytskyi

28040

Hospital Clinico San Carlos ( Site 0902), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 0901), Madrid

29425

MUSC Hollings Cancer Center ( Site 1715), Charleston

30060

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118), Marietta

33604

CHU Bordeaux Haut-Leveque ( Site 0305), Pessac

34722

Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002), Istanbul

35043

Philipps-Universitaet Marburg. ( Site 1252), Marburg

35100

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006), Izmir

38138

The West Clinic, PLLC dba West Cancer Center ( Site 1149), Germantown

38440

Klinikum Wolfsburg ( Site 1256), Wolfsburg

40217

Norton Cancer Institute ( Site 1139), Louisville

40447

China Medical University Hospital ( Site 0953), Taichung

41009

Hospital Universitario Virgen Macarena ( Site 0906), Seville

41063

Kliniken Maria Hilf GmbH ( Site 1255), Mönchengladbach

44093

CHU Hotel Dieu Nantes ( Site 0303), Nantes

46050

Beacon Hospital Sdn Bhd ( Site 1305), Petaling Jaya

49102

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657), Dnipro

53113

Johanniter Krankenhaus Bonn ( Site 1254), Bonn

59100

Pantai Hospital Kuala Lumpur ( Site 1303), Bangsar

University Malaya Medical Centre ( Site 1301), Kuala Lumpur

62250

Institut Kanser Negara - National Cancer Institute ( Site 1302), Putrajaya

65025

Odessa Regional Clinical Hospital ( Site 1664), Odesa

71013

IRCCS Casa Sollievo della Sofferenza ( Site 0554), San Giovanni Rotondo

75015

Hopital Europeen Georges Pompidou ( Site 0300), Paris

76018

MI Precarpathian Clinical Oncology Center ( Site 1654), Ivano-Frankivsk

80131

Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556), Napoli

81377

LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253), Munich

84000

Institut du Cancer Avignon-Provence ( Site 0306), Avignon

84107

Intermountain Medical Center ( Site 1707), Murray

86021

CHU Poitiers ( Site 0304), Poitiers

95122

A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553), Catania

97239

Oregon Health & Science University ( Site 1141), Portland

98109

Seattle Cancer Care Alliance ( Site 1107), Seattle

105094

SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854), Kirov

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870), Moscow

115682

FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851), Moscow

130012

Jilin Cancer Hospital ( Site 1163), Changchun

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850), Yaroslavl

188663

"SHBI Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman-Clinical Trials Department (", Saint Petersburg

197706

City Hospital #40 ( Site 0853), Saint Petersburg

197758

Clinical Research Center of specialized types medical care-Oncology ( Site 0860), Saint Petersburg

200072

Shanghai Tenth People's Hospital ( Site 1170), Shanghai

201321

Fudan University Shanghai Cancer Center ( Site 1176), Shanghai

213000

Changzhou Cancer Hospital-Department of Oncology ( Site 1183), Changzhou

214122

Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185), Wuxi

230601

The Second Affiliated Hospital of Anhui Medical University ( Site 1179), Hefei

250000

Jinan Central Hospital ( Site 1167), Jinan

300060

Tianjin Medical University Cancer Institute and Hospital ( Site 1161), Tianjin

310005

Zhejiang Cancer Hospital ( Site 1180), Hangzhou

310018

Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173), Hangzhou

332001

West China Hospital Sichuan University ( Site 1172), Chengdu

350014

Fujian Province Cancer Hospital ( Site 1178), Fuzhou

400030

Chongqing Cancer Hospital ( Site 1151), Chongqing

410008

Xiangya Hospital Central South University ( Site 1171), Changsha

410013

Hunan Cancer Hospital ( Site 1174), Changsha

The Third Xiangya Hospital of Central South University ( Site 1175), Changsha

430022

Wuhan Union Hospital Cancer Center ( Site 1162), Wuhan

430079

Hubei Cancer Hospital ( Site 1152), Wuhan

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871), Ufa

510060

Sun Yat-Sen University Cancer Center ( Site 1150), Guangzhou

510515

Southern Medical University Nanfang Hospital ( Site 1154), Guangzhou

510655

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159), Guangzhou

531021

Guangxi Medical University Affiliated Tumor Hospital ( Site 1158), Nanning

570311

Hainan General Hospital ( Site 1177), Haikou

634045

Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872), Tomsk

650106

Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169), Kunming

1720430

IC La Serena Research ( Site 0202), La Serena

3109601

Rambam Health Care Campus-Oncology Division ( Site 0500), Haifa

3339419

Bnei Zion Medical Center ( Site 0506), Haifa

4800827

Centro Investigacion Cancer James Lind ( Site 0204), Temuco

4941492

Rabin Medical Center ( Site 0503), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 0501), Ramat Gan

5500656

Clinica Puerto Montt ( Site 0211), Port Montt

5898511

Kindai University Hospital ( Site 0607), Sayama

6423906

Sourasky Medical Center ( Site 0502), Tel Aviv

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0208), Santiago

7510032

Oncovida ( Site 0209), Santiago

7747629

Assuta Ashdod Public ( Site 0507), Ashdod

8241479

Clínica Vespucio ( Site 0205), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 0206), Santiago

8420383

Bradfordhill ( Site 0200), Santiago

9112001

Hadassa Ein Karem Medical Center ( Site 0504), Jerusalem

08903

Rutgers Cancer Institute of New Jersey ( Site 1105), New Brunswick

75390-9063

UT Southwestern Medical Center ( Site 1709), Dallas

N6A 5W9

London Regional Cancer Program - London HSC ( Site 0154), London

K1H 8L6

The Ottawa Hospital ( Site 0151), Ottawa

M5G 2M9

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155), Toronto

656 53

Masarykuv onkologicky ustav ( Site 1203), Brno

150 06

Fakultni nemocnice v Motole ( Site 1201), Prague

500 05

Fakultni nemocnice Hradec Kralove ( Site 1207), Hradec Králové

779 00

Fakultni nemocnice Olomouc ( Site 1204), Olomouc

100 34

Fakultni nemocnice Kralovske Vinohrady ( Site 1208), Prague

140 59

Fakultni Thomayerova nemocnice ( Site 1205), Prague

180 81

Fakultni nemocnice Na Bulovce ( Site 1202), Prague

06120

Universitätsklinikum Halle ( Site 1251), Halle

00168

Policlinico Gemelli di Roma ( Site 0552), Roma

277-8577

National Cancer Center Hospital East ( Site 0600), Kashiwa

761-0793

Kagawa University Hospital ( Site 0608), Kita-gun

362-0806

Saitama Prefectural Cancer Center ( Site 0603), Kitaadachi-gun

411-8777

Shizuoka Cancer Center ( Site 0605), Sunto-gun,

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 0609), Fukuoka

104-0045

National Cancer Center Hospital ( Site 0601), Tokyo

135-8550

Japanese Foundation for Cancer Research ( Site 0602), Tokyo

0450

Oslo Universitetssykehus HF. Ulleval ( Site 1351), Oslo

05505

Asan Medical Center ( Site 0650), Songpagu

03080

Seoul National University Hospital ( Site 0653), Seoul

03722

Severance Hospital ( Site 0652), Seoul

06351

Samsung Medical Center ( Site 0651), Seoul

08035

Hospital Universitari Vall d Hebron ( Site 0900), Barcelona

08041

Hospital Sant Pau i la Santa Creu ( Site 0905), Barcelona

01120

Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007), Adana

01130

Acibadem Adana Hastanesi ( Site 1008), Adana

06010

Gulhane Egitim ve Arastirma Hastanesi ( Site 1009), Ankara

06230

Hacettepe Universitesi Tip Fakultesi ( Site 1003), Ankara

06800

Ankara Sehir Hastanesi ( Site 1005), Ankara

07100

Antalya Egitim ve Arastirma Hastanesi ( Site 1010), Antalya

WC1E 6AG

University College London Hospitals NHS Foundation Trust ( Site 1056), London

SW3 6JJ

Royal Marsden NHS Foundation Trust ( Site 1064), London

W12 0HS

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052), London

SM25PT

Royal Marsden NHS Trust ( Site 1063), Sutton

CV2 2DX

University Hospital Coventry & Warwickshire ( Site 1062), Coventry

Unknown

Velindre Cancer Centre ( Site 1058), Cardiff

LS9 7TF

Leeds Teaching Hospitals NHS Trust ( Site 1050), Leeds

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05064059 - A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) | Biotech Hunter | Biotech Hunter