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Clinical Trial Finder

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Program Status

Active, not recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Lenvatinib, Pembrolizumab, Regorafenib, TAS-102 (trifluridine and tipiracil)

Tags

MSS/ pMMR
Location Location Status
United States
Pacific Cancer Care ( Site 0031)
Monterey, California 93940
Active, not recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021)
Marietta, Georgia 30060
Active, not recruiting
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
Chicago, Illinois 60637
Active, not recruiting
MFSMC-HJWCI-Oncology Research ( Site 0012)
Baltimore, Maryland 21237
Active, not recruiting
MedStar Good Samaritan Hospital-Oncology Research ( Site 0038)
Baltimore, Maryland 21239
Active, not recruiting
Henry Ford Hospital ( Site 0024)
Detroit, Michigan 48202
Active, not recruiting
St. Vincent Frontier Cancer Center ( Site 0005)
Billings, Montana 59102
Active, not recruiting
Providence Portland Medical Center ( Site 0019)
Portland, Oregon 97213
Active, not recruiting
Thomas Jefferson University - Clinical Trials Office ( Site 0027)
Philadelphia, Pennsylvania 19107
Active, not recruiting
Inova Schar Cancer Institute ( Site 0022)
Fairfax, Virginia 22031
Active, not recruiting
Blue Ridge Cancer Care ( Site 0036)
Roanoke, Virginia 24014
Active, not recruiting
Northwest Medical Specialties, PLLC ( Site 0033)
Tacoma, Washington 98405
Active, not recruiting
Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0308)
Ciudad autónoma de Buenos Aires, Buenos Aires C1280AEB
Active, not recruiting
Fundación favaloro para la Docencia e Investigación Médica-Oncología ( Site 0301)
Buenos Aires, Caba C1096AAS
Active, not recruiting
Instituto de Oncología de Rosario ( Site 0305)
Rosario, Santa Fe S2000KZE
Active, not recruiting
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303)
Buenos Aires 1431
Active, not recruiting
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300)
Buenos Aires C1012AAR
Active, not recruiting
Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland 4029
Active, not recruiting
Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500)
Greenslopes, Queensland 4120
Active, not recruiting
The Queen Elizabeth Hospital-Cancer Clinical Trials ( Site 1503)
Woodville, South Australia 5011
Active, not recruiting
Epworth Freemasons ( Site 1506)
Melbourne, Victoria 3002
Active, not recruiting
Western Health-Sunshine & Footscray Hospitals ( Site 1501)
St Albans, Victoria 3021
Active, not recruiting
Hollywood Private Hospital-Medical Oncology ( Site 1507)
Perth, Western Australia 6009
Active, not recruiting
Canada
Cross Cancer Institute-Department of Medical Oncology ( Site 0207)
Edmonton, Alberta T6G 1Z2
Active, not recruiting
NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200)
Halifax, Nova Scotia B3H 2Y9
Active, not recruiting
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
Hamilton, Ontario L8V 4X2
Active, not recruiting
North York General Hospital ( Site 0206)
Toronto, Ontario M2K1E1
Active, not recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0211)
Montreal, Quebec H1T 2M4
Active, not recruiting
CHU de Quebec - Université Laval - Hotel Dieu de Quebec-Hemato-Dermato-Gyneco-Oncology ( Site 0203)
Québec, Quebec G1R 3S1
Active, not recruiting
China
The First People's Hospital of Foshan-Gastrointestinal oncology ( Site 1604)
Foshan, Guangdong 528041
Active, not recruiting
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1600)
Guangzhou, Guangdong 510060
Active, not recruiting
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1606)
Hangzhou, Zhejiang 310016
Active, not recruiting
Denmark
Rigshospitalet ( Site 0702)
Copenhagen, Hovedstaden 2100
Active, not recruiting
Herlev and Gentofte Hospital-Department of Oncology ( Site 0704)
Copenhagen, Hovedstaden 2730
Active, not recruiting
Odense Universitetshospital ( Site 0700)
Odense, Syddanmark 5000
Active, not recruiting
Vejle Sygehus-Department of Oncology ( Site 0701)
Vejle, Syddanmark DK-7100
Active, not recruiting
Germany
Klinikum am Steinenberg-Kreiskliniken Reutlingen GmbH ( Site 0908)
Reutlingen, Baden-Wurttemberg 72764
Active, not recruiting
klinikum rechts der isar der technischen universität münchen-Klinik und Poliklinik für Innere Mediz
Munich, Bayern 81675
Active, not recruiting
Onkodok GmbH ( Site 0907)
Gütersloh, Nordrhein-Westfalen 33332
Active, not recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)
Berlin 10117
Active, not recruiting
Asklepios Altona-Oncology ( Site 0903)
Hamburg 22763
Active, not recruiting
Israel
Rambam Health Care Campus-Oncology ( Site 0800)
Haifa 3109601
Active, not recruiting
Shaare Zedek Medical Center-Oncology ( Site 0804)
Jerusalem 9013102
Active, not recruiting
Hadassah Medical Center-Oncology ( Site 0802)
Jerusalem 9112001
Active, not recruiting
Sheba Medical Center ( Site 0803)
Ramat Gan 5262100
Active, not recruiting
Sourasky Medical Center-Oncology ( Site 0801)
Tel Aviv 6423906
Active, not recruiting
Japan
Aichi Cancer Center Hospital ( Site 1701)
Nagoya, Aichi 4648681
Active, not recruiting
National Cancer Center Hospital East ( Site 1700)
Kashiwa, Chiba 277-8577
Active, not recruiting
Kobe City Medical Center General Hospital ( Site 1707)
Kobe, Hyogo 650-0047
Active, not recruiting
Kagawa University Hospital ( Site 1708)
Kita, Kagawa 761-0701
Active, not recruiting
Kanagawa cancer center ( Site 1705)
Yokohama, Kanagawa 2418515
Active, not recruiting
Kindai University Hospital- Osakasayama Campus-Medical Oncology ( Site 1704)
Osakasayama, Osaka 589-8511
Active, not recruiting
Saitama Prefectural Cancer Center ( Site 1703)
Ina-machi, Saitama 362-0806
Active, not recruiting
Shizuoka Cancer Center ( Site 1706)
Nagaizumi, Shizuoka 411-8777
Active, not recruiting
National Hospital Organization Kyushu Cancer Center ( Site 1709)
Fukuoka 811-1395
Active, not recruiting
National Cancer Center Hospital ( Site 1702)
Tokyo 104-0045
Active, not recruiting
Japanese Foundation for Cancer Research-GI Oncology ( Site 1710)
Tokyo 135-8550
Active, not recruiting
Korea, Republic of
Korea University Anam Hospital ( Site 1806)
Seoul 02841
Active, not recruiting
Seoul National University Hospital-Internal Medicine ( Site 1800)
Seoul 03080
Active, not recruiting
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1801)
Seoul 03722
Active, not recruiting
Asan Medical Center ( Site 1803)
Seoul 05505
Active, not recruiting
Samsung Medical Center-Division of Hematology/Oncology ( Site 1804)
Seoul 06351
Active, not recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1802)
Seoul 06591
Active, not recruiting
Russian Federation
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1109)
Ufa, Baskortostan, Respublika 450054
Active, not recruiting
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1100)
Saint Petersburg, Leningradskaya Oblast 198255
Active, not recruiting
The National Medico-Surgical Center N.I. Pirogov ( Site 1102)
Moscow, Moskva 105203
Active, not recruiting
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1107)
Moscow, Moskva 115478
Active, not recruiting
First Moscow State Medical University I.M. Sechenov-Interhospital Institution ""Health Management (
Moscow, Moskva 119991
Active, not recruiting
SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY ( Site 1108)
Ekaterinburg, Sverdlovskaya Oblast 620905
Active, not recruiting
SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 1111)
Sankt-Peterburg 188663
Active, not recruiting
Spain
Hospital Universitario Central de Asturias-Digestive ( Site 1200)
Oviedo, Asturias 33011
Active, not recruiting
Hospital Universitario Marqués de Valdecilla ( Site 1201)
Santander, Cantabria 39008
Active, not recruiting
Hospital Universitari Vall d'Hebron-Oncology ( Site 1204)
Barcelona 08035
Active, not recruiting
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1205)
Madrid 28007
Active, not recruiting
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1207)
Sevilla 41014
Active, not recruiting
Taiwan
China Medical University Hospital-Surgical Department ( Site 1903)
Taichung 40447
Active, not recruiting
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 1904)
Tainan 704
Active, not recruiting
National Taiwan University Hospital ( Site 1900)
Taipei 10002
Active, not recruiting
Taipei Veterans General Hospital-Oncology ( Site 1901)
Taipei 11217
Active, not recruiting
Chang Gung Medical Foundation.Linkou Branch ( Site 1902)
Taoyuan 333
Active, not recruiting
Turkey
Hacettepe Universitesi-oncology hospital ( Site 1302)
Ankara 06230
Active, not recruiting
Memorial Ankara Hastanesi-Medical Oncology ( Site 1304)
Ankara 06520
Active, not recruiting
Trakya University-Oncology ( Site 1303)
Edirne 22030
Active, not recruiting
Acıbadem Maslak Hastanesi ( Site 1307)
İstanbul 34457
Active, not recruiting
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1300)
Istanbul 34668
Active, not recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1301)
Istanbul 34722
Active, not recruiting
Ege University Medicine of Faculty-Medical Oncology ( Site 1305)
Izmir 35100
Active, not recruiting
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1306)
Malatya 44280
Active, not recruiting
United Kingdom
Addenbrooke's Hospital ( Site 1407)
Cambridge, Cambridgeshire CB2 0QQ
Active, not recruiting
UCLH-Cancer Clinical Trials Unit ( Site 1400)
London, Essex NW1 2PG
Active, not recruiting
Guy's & St Thomas' NHS Foundation Trust ( Site 1404)
London, London, City Of SE1 9RT
Active, not recruiting
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1403)
London, London, City Of SW3 6JJ
Active, not recruiting
Western General Hospital ( Site 1401)
Edinburgh, Midlothian EH4 2XU
Active, not recruiting
Royal Marsden Hospital (Sutton) ( Site 1409)
London, Surrey SM3 5PT
Active, not recruiting
The Christie-Medical Oncology ( Site 1411)
Manchester M20 4BX
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma (Stage IV A, B and C as defined by American Joint Committee on Cancer [AJCC] 8th edition). Note: Tumor must be determined to be NOT microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) by local testing

Has been previously treated for their disease and has shown disease progression as defined by RECIST 1.1 on or after or could not tolerate standard treatment, which must include ALL of the following agents if approved and locally available in the country where the participant is randomized:

fluoropyrimidine, irinotecan and oxaliplatin
with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab)
with anti- epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for RAS (KRAS/NRAS) wild-type (WT) participants
BRAF inhibitor (in combination with cetuximab +/- binimetinib) for BRAF V600E mutated metastatic colon cancer (mCRC)
Has measurable disease per RECIST 1.1 assessed by the investigator
Has provided to a designated central laboratory an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion which has not been previously irradiated
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days prior to randomization
Has a life expectancy of at least 3 months, based on the investigator assessment
Has the ability to swallow capsules or ingest a suspension orally or by a feeding tube
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 millimeter of mercury (mmHg) with no change in antihypertensive medications within 1 week prior to randomization
Male participants must agree to the following during the treatment period and for at least 90 days after the last dose of regorafenib or TAS-102 and at least 7 days after the last dose of lenvatinib: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception. The male contraception period should continue for at least 7 days after discontinuation of lenvatinib
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 30 days after the last dose of lenvatinib, 120 days after the last dose of pembrolizumab, and 180 days after the last dose of regorafenib or TAS-102 (whichever is last) AND agrees not to donate eggs (ova, oocytes)
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment

Exclusion Criteria

Exclusion Criteria:

Has a tumor that is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) per local testing
Has presence of gastrointestinal condition, eg, malabsorption, that might affect the absorption of study drug.
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
Has radiographic evidence of encasement or invasion of a major blood vessel invasion or of intratumoral cavitation. In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta
Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
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.

Participants with cardiac failure NYHA Class II, III and IV are not allowed to be assigned to the regorafenib in Arm B

Has a history of arterial thromboembolism within 12 months of start of study drug
Has urine protein ≥1 gram/24 hour
Has prolongation of QT interval corrected with Fridericia's formula (QTcF interval) to >480 milliseconds
Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with certain exceptions
Has serious nonhealing wound, ulcer or bone fracture
Has had major surgery within 3 weeks prior to first dose of study treatment
Has received biologic response modifiers (eg, granulocyte colony-stimulating factor) within 4 weeks before study entry
Has preexisting ≥Grade 3 gastrointestinal or nongastrointestinal fistula
Has received prior treatment with a combination of an anti-PD-1, anti-PD-L1, or anti PD-L2 agent with anti-VEGF monoclonal antibodies or vascular endothelial growth factor receptor (VEGFR) inhibitors
Has previously received regorafenib or TAS-102
Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to randomization
Has received prior radiotherapy within 2 weeks of start of study treatment
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
Has known intolerance to lenvatinib, regorafenib, or TAS-102 and/or any of their excipients
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first dose of study treatment
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 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 prior the first dose of study medication
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of Human Immunodeficiency Virus (HIV) infection
Has a 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 a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogenic tissue/solid organ transplant

NCT ID

NCT04776148

Date Trial Added

2021-03-01

Updated Date

2022-07-26