AzTrials
AzTrials

Colorectal CancerPhase 3NCT05064059

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)

A Phase 3 study testing favezelimab/pembrolizumab, regorafenib and TAS-102 in people with Colorectal Cancer, run by Merck Sharp & Dohme LLC at 152 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
favezelimab/pembrolizumab, regorafenib and TAS-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
152 sitesin 21 countries
Study dates
10 Nov 2021to 21 Feb 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
  • Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
  • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
  • Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
  • Has a life expectancy of at least 3 months, based on the investigator assessment.
  • Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
  • Has adequate organ function.

Who cannot join

  • Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
  • Has a history of acute or chronic pancreatitis.
  • Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
  • Has urine protein greater than or equal to 1g/24h.
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  • A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
  • Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
  • Has previously received regorafenib or TAS-102.
  • Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Has received a live or live-attenuated vaccine within 30 days 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 severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known history of Hepatitis B or known active Hepatitis C virus infection.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has had an allogenic tissue/solid organ transplant.

Trial locations and contacts

152 sites in 21 countries.

152 sites in 21 countries

China24 sites

  • Jilin Cancer Hospital ( Site 1163)

    Changchun, Jilin, 130012

  • Xiangya Hospital Central South University ( Site 1171)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 1174)

    Changsha, Hunan, 410013

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

    Changsha, Hunan, 410013

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

    Changzhou, Jiangsu, 213000

  • West China Hospital Sichuan University ( Site 1172)

    Chengdu, Sichuan, 332001

  • Chongqing Cancer Hospital ( Site 1151)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Province Cancer Hospital ( Site 1178)

    Fuzhou, Fujian, 350014

  • Sun Yat-Sen University Cancer Center ( Site 1150)

    Guangzhou, Guangdong, 510060

  • Southern Medical University Nanfang Hospital ( Site 1154)

    Guangzhou, Guangdong, 510515

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

    Guangzhou, Guangdong, 510655

  • Hainan General Hospital ( Site 1177)

    Haikou, Hainan, 570311

  • Zhejiang Cancer Hospital ( Site 1180)

    Hangzhou, Zhejiang, 310005

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

    Hangzhou, Zhejiang, 310018

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

    Hefei, Anhui, 230601

  • Jinan Central Hospital ( Site 1167)

    Jinan, Shandong, 250000

  • Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

    Kunming, Yunnan, 650106

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

    Nanning, Guangxi, 531021

  • Shanghai Tenth People's Hospital ( Site 1170)

    Shanghai, Shanghai Municipality, 200072

  • Fudan University Shanghai Cancer Center ( Site 1176)

    Shanghai, Shanghai Municipality, 201321

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

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union Hospital Cancer Center ( Site 1162)

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital ( Site 1152)

    Wuhan, Hubei, 430079

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

    Wuxi, Jiangsu, 214122

Other trials in China

United States15 sites

  • MUSC Hollings Cancer Center ( Site 1715)

    Charleston, South Carolina, 29425

  • UT Southwestern Medical Center ( Site 1709)

    Dallas, Texas, 75390-9063

  • Inova Schar Cancer Institute ( Site 1130)

    Fairfax, Virginia, 22031

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

    Germantown, Tennessee, 38138

  • Norton Cancer Institute ( Site 1139)

    Louisville, Kentucky, 40217

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

    Marietta, Georgia, 30060

  • Intermountain Medical Center ( Site 1707)

    Murray, Utah, 84107

  • Rutgers Cancer Institute of New Jersey ( Site 1105)

    New Brunswick, New Jersey, 08903

  • Memorial Sloan Kettering Cancer Center ( Site 1703)

    New York, New York, 10065

  • Oregon Health & Science University ( Site 1141)

    Portland, Oregon, 97239

  • VCU Health Adult Outpatient Pavillion ( Site 1712)

    Richmond, Virginia, 23219

  • Blue Ridge Cancer Care ( Site 1718)

    Roanoke, Virginia, 24014

  • Seattle Cancer Care Alliance ( Site 1107)

    Seattle, Washington, 98109

  • Georgetown University Hospital ( Site 1148)

    Washington D.C., District of Columbia, 20007

  • Sibley Memorial Hospital ( Site 1143)

    Washington D.C., District of Columbia, 20016

Other trials in United States

Russia9 sites

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

    Kirov, Kirov Oblast, 105094

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

    Moscow, Moscow, 105094

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

    Moscow, Moscow, 115682

  • City Hospital #40 ( Site 0853)

    Saint Petersburg, Sankt-Peterburg, 197706

  • Clinical Research Center of specialized types medical care-Oncology ( Site 0860)

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, 188663

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

    Tomsk, Tomsk Oblast, 634045

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)

    Ufa, Baskortostan, Respublika, 450054

  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Chile8 sites

  • IC La Serena Research ( Site 0202)

    La Serena, Coquimbo Region, 1720430

  • Clinica Puerto Montt ( Site 0211)

    Port Montt, Los Lagos Region, 5500656

  • Fundacion Arturo Lopez Perez FALP ( Site 0208)

    Santiago, Region M. de Santiago, 7500921

  • Oncovida ( Site 0209)

    Santiago, Region M. de Santiago, 7510032

  • Clínica Vespucio ( Site 0205)

    Santiago, Region M. de Santiago, 8241479

  • Pontificia Universidad Catolica de Chile ( Site 0206)

    Santiago, Region M. de Santiago, 8330032

  • Bradfordhill ( Site 0200)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigacion Cancer James Lind ( Site 0204)

    Temuco, Araucania, 4800827

Other trials in Chile

Japan8 sites

  • National Hospital Organization Kyushu Cancer Center ( Site 0609)

    Fukuoka, 811-1395

  • National Cancer Center Hospital East ( Site 0600)

    Kashiwa, Chiba, 277-8577

  • Kagawa University Hospital ( Site 0608)

    Kita-gun, Kagawa-ken, 761-0793

  • Saitama Prefectural Cancer Center ( Site 0603)

    Kitaadachi-gun, Saitama, 362-0806

  • Kindai University Hospital ( Site 0607)

    Sayama, Osaka, 5898511

  • Shizuoka Cancer Center ( Site 0605)

    Sunto-gun,, Shizuoka, 411-8777

  • National Cancer Center Hospital ( Site 0601)

    Tokyo, 104-0045

  • Japanese Foundation for Cancer Research ( Site 0602)

    Tokyo, 135-8550

Other trials in Japan

Turkey (Türkiye)8 sites

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

    Adana, 01120

  • Acibadem Adana Hastanesi ( Site 1008)

    Adana, 01130

  • Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)

    Ankara, 06010

  • Hacettepe Universitesi Tip Fakultesi ( Site 1003)

    Ankara, 06230

  • Ankara Sehir Hastanesi ( Site 1005)

    Ankara, 06800

  • Antalya Egitim ve Arastirma Hastanesi ( Site 1010)

    Antalya, 07100

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

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Czechia7 sites

  • Masarykuv onkologicky ustav ( Site 1203)

    Brno, Brno-mesto, 656 53

  • Fakultni nemocnice Hradec Kralove ( Site 1207)

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc ( Site 1204)

    Olomouc, 779 00

  • Fakultni nemocnice v Motole ( Site 1201)

    Prague, Praha, Hlavni Mesto, 150 06

  • Fakultni nemocnice Kralovske Vinohrady ( Site 1208)

    Prague, 100 34

  • Fakultni Thomayerova nemocnice ( Site 1205)

    Prague, 140 59

  • Fakultni nemocnice Na Bulovce ( Site 1202)

    Prague, 180 81

Other trials in Czechia

Germany7 sites

  • Johanniter Krankenhaus Bonn ( Site 1254)

    Bonn, North Rhine-Westphalia, 53113

  • Universitätsklinikum Halle ( Site 1251)

    Halle, Saxony-Anhalt, 06120

  • Katholisches Marienkrankenhaus gGmbH ( Site 1257)

    Hamburg, 22087

  • Philipps-Universitaet Marburg. ( Site 1252)

    Marburg, Hesse, 35043

  • Kliniken Maria Hilf GmbH ( Site 1255)

    Mönchengladbach, North Rhine-Westphalia, 41063

  • LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)

    Munich, Bavaria, 81377

  • Klinikum Wolfsburg ( Site 1256)

    Wolfsburg, Lower Saxony, 38440

Other trials in Germany

Israel7 sites

  • Assuta Ashdod Public ( Site 0507)

    Ashdod, 7747629

  • Rambam Health Care Campus-Oncology Division ( Site 0500)

    Haifa, 3109601

  • Bnei Zion Medical Center ( Site 0506)

    Haifa, 3339419

  • Hadassa Ein Karem Medical Center ( Site 0504)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 0503)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 0501)

    Ramat Gan, 5262000

  • Sourasky Medical Center ( Site 0502)

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom7 sites

  • Velindre Cancer Centre ( Site 1058)

    Cardiff

  • University Hospital Coventry & Warwickshire ( Site 1062)

    Coventry, Warwickshire, CV2 2DX

  • Leeds Teaching Hospitals NHS Trust ( Site 1050)

    Leeds, LS9 7TF

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

    London, Camden, WC1E 6AG

  • Royal Marsden NHS Foundation Trust ( Site 1064)

    London, London, City of, SW3 6JJ

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

    London, London, City of, W12 0HS

  • Royal Marsden NHS Trust ( Site 1063)

    Sutton, London, City of, SM25PT

Other trials in United Kingdom

Australia6 sites

  • Frankston Hospital ( Site 0056)

    Frankston, Victoria, 3199

  • Royal Brisbane and Women s Hospital ( Site 0058)

    Herston, Queensland, 4029

  • St John of God Subiaco Hospital ( Site 0051)

    Perth, Western Australia, 6008

  • Western Health-Sunshine & Footscray Hospitals ( Site 0052)

    St Albans, Victoria, 3021

  • Westmead Hospital ( Site 0057)

    Westmead, New South Wales, 2145

  • Queen Elizabeth Hospital ( Site 0050)

    Woodville South, South Australia, 5011

Other trials in Australia

Italy6 sites

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

    Catania, 95122

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)

    Milan, 20162

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

    Naples, 80131

  • Policlinico Gemelli di Roma ( Site 0552)

    Roma, Abruzzo, 00168

  • Istituto Clinico Humanitas - Cancer Center ( Site 0555)

    Rozzano, Milano, 20089

  • IRCCS Casa Sollievo della Sofferenza ( Site 0554)

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Taiwan6 sites

  • Chang Gung Medical Foundation - Kaohsiung ( Site 0956)

    Kaohsiung City, Changhua, 833

  • China Medical University Hospital ( Site 0953)

    Taichung, 40447

  • National Cheng Kung University Hospital ( Site 0955)

    Tainan, 704

  • National Taiwan University Hospital ( Site 0950)

    Taipei, 10048

  • Taipei Veterans General Hospital ( Site 0951)

    Taipei, 11217

  • Chang Gung Medical Foundation. Linkou ( Site 0952)

    Taoyuan, 333

Other trials in Taiwan

France5 sites

  • Institut du Cancer Avignon-Provence ( Site 0306)

    Avignon, Vaucluse, 84000

  • CHU Hotel Dieu Nantes ( Site 0303)

    Nantes, Pays de la Loire Region, 44093

  • Hopital Europeen Georges Pompidou ( Site 0300)

    Paris, 75015

  • CHU Bordeaux Haut-Leveque ( Site 0305)

    Pessac, Gironde, 33604

  • CHU Poitiers ( Site 0304)

    Poitiers, Vienne, 86021

Other trials in France

Norway5 sites

  • Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)

    Bergen, Vestfold, 5053

  • Akershus universitetssykehus ( Site 1352)

    Loerenskog, Akershus, 1478

  • Oslo Universitetssykehus HF. Ulleval ( Site 1351)

    Oslo, 0450

  • Universitetssykehuset i Nord Norge. ( Site 1355)

    Tromsø, Troms, 9019

  • St Olavs Hospital ( Site 1354)

    Trondheim, Sor-Trondelag, 7030

Other trials in Norway

Spain5 sites

  • Hospital Universitari Vall d Hebron ( Site 0900)

    Barcelona, 08035

  • Hospital Sant Pau i la Santa Creu ( Site 0905)

    Barcelona, 08041

  • Hospital Clinico San Carlos ( Site 0902)

    Madrid, 28040

  • Hospital Universitario 12 de Octubre ( Site 0901)

    Madrid, 28041

  • Hospital Universitario Virgen Macarena ( Site 0906)

    Seville, 41009

Other trials in Spain

Malaysia4 sites

  • Pantai Hospital Kuala Lumpur ( Site 1303)

    Bangsar, Kuala Lumpur, 59100

  • University Malaya Medical Centre ( Site 1301)

    Kuala Lumpur, 59100

  • Beacon Hospital Sdn Bhd ( Site 1305)

    Petaling Jaya, Selangor, 46050

  • Institut Kanser Negara - National Cancer Institute ( Site 1302)

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

South Africa4 sites

  • Cape Town Oncology Trials Pty Ltd ( Site 1506)

    Kraaifontein, Western Cape, 7570

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)

    Port Elizabeth, Eastern Cape, 6045

  • Cancercare Rondebosch Oncology ( Site 1509)

    Rondebosch, Western Cape, 7700

  • Sandton Oncology Medical Group PTY LTD ( Site 1501)

    Sandton, Gauteng, 2196

Other trials in South Africa

South Korea4 sites

  • Seoul National University Hospital ( Site 0653)

    Seoul, 03080

  • Severance Hospital ( Site 0652)

    Seoul, 03722

  • Samsung Medical Center ( Site 0651)

    Seoul, 06351

  • Asan Medical Center ( Site 0650)

    Songpagu, Seoul, 05505

Other trials in South Korea

Ukraine4 sites

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

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 1654)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Ukrainian Center of Tomotherapy ( Site 1658)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

  • Odessa Regional Clinical Hospital ( Site 1664)

    Odesa, Odesa Oblast, 65025

Other trials in Ukraine

Canada3 sites

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

    London, Ontario, N6A 5W9

  • The Ottawa Hospital ( Site 0151)

    Ottawa, Ontario, K1H 8L6

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

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).

The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Being tested
favezelimab/pembrolizumab, regorafenib, TAS-102
Keywords
Programmed Cell Death-1 (PD1, PD-1),, Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
Medical subject headings
Colorectal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • favezelimab/pembrolizumabBiological

    Also called MK-4280A

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

  • regorafenibDrug

    Also called STIVARGA®, REGONIX®

    Oral

  • TAS-102Drug

    Also called LONSURF®

    Oral

Study groups in NCT05064059
Study groupRoleWhat they receive
Favezelimab/PembrolizumabExperimentalParticipants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
Receives: Biological: favezelimab/pembrolizumab
Standard of Care (Regorafenib or TAS-102)Active comparatorAt the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.
Receives: Drug: regorafenib; Drug: TAS-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 33 months

Secondary outcomes (13)

  1. Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

    Measured: Up to approximately 21 months

  2. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

    ORR was defined as the percentage of participants who achieved a confirmed complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesion) per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 21 months

  3. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation.

    Measured: Up to approximately 21 months

  4. Number of Participants Who Experienced at Least One Adverse Event (AE)

    An AE was 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.

    Measured: Up to approximately 31 months

  5. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE was 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. The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to approximately 28 months

  6. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome.

    Measured: Baseline and up to approximately 8 weeks

  7. Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome

    Measured: Baseline and up to approximately 8 weeks

  8. Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.

    Measured: Baseline and up to approximately 8 weeks

  9. Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

    The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.

    Measured: Baseline and up to approximately 8 weeks

  10. Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) \& QoL combined score (EORTC QLQ-C30 Item 30). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 38 months

  11. TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 38 months

  12. TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 38 months

  13. TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

    TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start10 Nov 2021
  3. Primary completion15 Aug 2024
  4. Study completion21 Feb 2025

Resources

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
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064059
Sponsor's protocol ID
4280A-007
Other IDs
MK-4280A-007, jRCT2031210482, 2024-511043-25-00, U1111-1302-9933
Status last verified
May 2026
First submitted
29 Sep 2021
Last updated
26 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.

    PubMed 41811823

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing favezelimab/pembrolizumab, regorafenib and TAS-102 in people with Colorectal Cancer, run by Merck Sharp & Dohme LLC at 152 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in China, United States, Russia, Chile, Japan and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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