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New combo therapy shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT04776148

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, lenvatinib and pembrolizumab, against the usual treatments for people with advanced colorectal cancer that had spread and stopped responding to prior therapy. About 563 adults took part. The goal was to see if the new combo helped people live longer. This is a disease control study, not a cure, as ongoing management is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

563 people

The number who actually took part.

Started

Mar 2021

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. fluoropyrimidine, irinotecan and oxaliplatin 2. with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) 3. with anti- epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for RAS (KRAS/NRAS) wild-type (WT) participants 4. 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: * 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 colorectal adenocarcinoma colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal neoplasms

Contacts and locations

Locations

  • Acıbadem Maslak Hastanesi ( Site 1307)

    Istanbul, 34457, Turkey (Türkiye)

  • Addenbrooke's Hospital ( Site 1407)

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Aichi Cancer Center Hospital ( Site 1701)

    Nagoya, Aichi-ken, 4648681, Japan

  • Asan Medical Center ( Site 1803)

    Seoul, 05505, South Korea

  • Asklepios Altona-Oncology ( Site 0903)

    Hamburg, 22763, Germany

  • Blue Ridge Cancer Care ( Site 0036)

    Roanoke, Virginia, 24014, United States

  • CHU de Quebec - Université Laval - Hotel Dieu de Quebec-Hemato-Dermato-Gyneco-Oncology ( Site 0203)

    Québec, Quebec, G1R 3S1, Canada

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0211)

    Montreal, Quebec, H1T 2M4, Canada

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303)

    Buenos Aires, 1431, Argentina

  • Chang Gung Medical Foundation.Linkou Branch ( Site 1902)

    Taoyuan, 333, Taiwan

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)

    Berlin, 10117, Germany

  • China Medical University Hospital-Surgical Department ( Site 1903)

    Taichung, 40447, Taiwan

  • Cross Cancer Institute-Department of Medical Oncology ( Site 0207)

    Edmonton, Alberta, T6G 1Z2, Canada

  • Ege University Medicine of Faculty-Medical Oncology ( Site 1305)

    Izmir, 35100, Turkey (Türkiye)

  • Epworth Freemasons ( Site 1506)

    Melbourne, Victoria, 3002, Australia

  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1107)

    Moscow, Moscow, 115478, Russia

  • First Moscow State Medical University I.M. Sechenov-Interhospital Institution ""Health Management (

    Moscow, Moscow, 119991, Russia

  • Fundación favaloro para la Docencia e Investigación Médica-Oncología ( Site 0301)

    Buenos Aires, Buenos Aires F.D., C1096AAS, Argentina

  • GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1109)

    Ufa, Baskortostan, Respublika, 450054, Russia

  • Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500)

    Greenslopes, Queensland, 4120, Australia

  • Guy's & St Thomas' NHS Foundation Trust ( Site 1404)

    London, London, City of, SE1 9RT, United Kingdom

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1205)

    Madrid, 28007, Spain

  • Hacettepe Universitesi-oncology hospital ( Site 1302)

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center-Oncology ( Site 0802)

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)

    Hamilton, Ontario, L8V 4X2, Canada

  • Henry Ford Hospital ( Site 0024)

    Detroit, Michigan, 48202, United States

  • Herlev and Gentofte Hospital-Department of Oncology ( Site 0704)

    Copenhagen, Capital Region, 2730, Denmark

  • Hollywood Private Hospital-Medical Oncology ( Site 1507)

    Perth, Western Australia, 6009, Australia

  • Hospital Británico de Buenos Aires-Oncology ( Site 0308)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 1204)

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias-Digestive ( Site 1200)

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Marqués de Valdecilla ( Site 1201)

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1207)

    Seville, 41014, Spain

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300)

    Buenos Aires, C1012AAR, Argentina

  • Inova Schar Cancer Institute ( Site 0022)

    Fairfax, Virginia, 22031, United States

  • Instituto de Oncología de Rosario ( Site 0305)

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1300)

    Istanbul, 34668, Turkey (Türkiye)

  • Japanese Foundation for Cancer Research-GI Oncology ( Site 1710)

    Tokyo, 135-8550, Japan

  • Kagawa University Hospital ( Site 1708)

    Kita, Kagawa-ken, 761-0701, Japan

  • Kanagawa cancer center ( Site 1705)

    Yokohama, Kanagawa, 2418515, Japan

  • Kindai University Hospital- Osakasayama Campus-Medical Oncology ( Site 1704)

    Sayama, Osaka, 589-8511, Japan

  • Klinikum am Steinenberg-Kreiskliniken Reutlingen GmbH ( Site 0908)

    Reutlingen, Baden-Wurttemberg, 72764, Germany

  • Kobe City Medical Center General Hospital ( Site 1707)

    Kobe, Hyōgo, 650-0047, Japan

  • Korea University Anam Hospital ( Site 1806)

    Seoul, 02841, South Korea

  • MFSMC-HJWCI-Oncology Research ( Site 0012)

    Baltimore, Maryland, 21237, United States

  • MedStar Good Samaritan Hospital-Oncology Research ( Site 0038)

    Baltimore, Maryland, 21239, United States

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1304)

    Ankara, 06520, Turkey (Türkiye)

  • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 1904)

    Tainan, 704, Taiwan

  • NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200)

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • National Cancer Center Hospital ( Site 1702)

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 1700)

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center ( Site 1709)

    Fukuoka, 811-1395, Japan

  • National Taiwan University Hospital ( Site 1900)

    Taipei, 10002, Taiwan

  • North York General Hospital ( Site 0206)

    Toronto, Ontario, M2K1E1, Canada

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021)

    Marietta, Georgia, 30060, United States

  • Northwest Medical Specialties, PLLC ( Site 0033)

    Tacoma, Washington, 98405, United States

  • Odense Universitetshospital ( Site 0700)

    Odense, Region Syddanmark, 5000, Denmark

  • Onkodok GmbH ( Site 0907)

    Gütersloh, North Rhine-Westphalia, 33332, Germany

  • Pacific Cancer Care ( Site 0031)

    Monterey, California, 93940, United States

  • Providence Portland Medical Center ( Site 0019)

    Portland, Oregon, 97213, United States

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1403)

    London, London, City of, SW3 6JJ, United Kingdom

  • Rambam Health Care Campus-Oncology ( Site 0800)

    Haifa, 3109601, Israel

  • Rigshospitalet ( Site 0702)

    Copenhagen, Capital Region, 2100, Denmark

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

    Brisbane, Queensland, 4029, Australia

  • Royal Marsden Hospital (Sutton) ( Site 1409)

    London, Surrey, SM3 5PT, United Kingdom

  • SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 1111)

    Saint Petersburg, 188663, Russia

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1600)

    Guangzhou, Guangdong, 510060, China

  • SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY ( Site 1108)

    Yekaterinburg, Sverdlovsk Oblast, 620905, Russia

  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1100)

    Saint Petersburg, Leningradskaya Oblast', 198255, Russia

  • Saitama Prefectural Cancer Center ( Site 1703)

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1804)

    Seoul, 06351, South Korea

  • Seoul National University Hospital-Internal Medicine ( Site 1800)

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1801)

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center-Oncology ( Site 0804)

    Jerusalem, 9013102, Israel

  • Sheba Medical Center ( Site 0803)

    Ramat Gan, 5262100, Israel

  • Shizuoka Cancer Center ( Site 1706)

    Nakatogari, Shizuoka, 411-8777, Japan

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 1606)

    Hangzhou, Zhejiang, 310016, China

  • Sourasky Medical Center-Oncology ( Site 0801)

    Tel Aviv, 6423906, Israel

  • St. Vincent Frontier Cancer Center ( Site 0005)

    Billings, Montana, 59102, United States

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1301)

    Istanbul, 34722, Turkey (Türkiye)

  • Taipei Veterans General Hospital-Oncology ( Site 1901)

    Taipei, 11217, Taiwan

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1802)

    Seoul, 06591, South Korea

  • The Christie-Medical Oncology ( Site 1411)

    Manchester, M20 4BX, United Kingdom

  • The First People's Hospital of Foshan-Gastrointestinal oncology ( Site 1604)

    Foshan, Guangdong, 528041, China

  • The National Medico-Surgical Center N.I. Pirogov ( Site 1102)

    Moscow, Moscow, 105203, Russia

  • The Queen Elizabeth Hospital-Cancer Clinical Trials ( Site 1503)

    Woodville, South Australia, 5011, Australia

  • Thomas Jefferson University - Clinical Trials Office ( Site 0027)

    Philadelphia, Pennsylvania, 19107, United States

  • Trakya University-Oncology ( Site 1303)

    Edirne, 22030, Turkey (Türkiye)

  • UCLH-Cancer Clinical Trials Unit ( Site 1400)

    London, Essex, NW1 2PG, United Kingdom

  • University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P

    Chicago, Illinois, 60637, United States

  • Vejle Sygehus-Department of Oncology ( Site 0701)

    Vejle, Region Syddanmark, DK-7100, Denmark

  • Western General Hospital ( Site 1401)

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Western Health-Sunshine & Footscray Hospitals ( Site 1501)

    St Albans, Victoria, 3021, Australia

  • klinikum rechts der isar der technischen universität münchen-Klinik und Poliklinik für Innere Mediz

    Munich, Bavaria, 81675, Germany

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1306)

    Malatya, 44280, Turkey (Türkiye)

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