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New combo shows promise for Hard-to-Treat cancers

NCT ID NCT03797326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, in 611 people with advanced cancers like breast, ovarian, stomach, colorectal, brain, bile duct, or pancreatic cancer that had stopped responding to standard treatments. The goal was to see if the combo could shrink tumors or slow disease progression. While some patients saw benefit, the treatment is not a cure and requires ongoing medication.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

611 people

The number who actually took part.

Started

Feb 2019

Finished

Oct 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 a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer * Must have progressed on or since the last treatment * Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR * Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period * Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation * Has adequate organ function For Triple Negative Breast Cancer Participants: * Has received one or 2 prior lines of therapy * Has Lactate Dehydrogenase (LDH) \<2.0 x Upper Limit of Normal (ULN) * Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses For Ovarian Cancer Participants: \- Has primary ovarian cancer and has received 3 prior lines of therapy. For Gastric Cancer Participants: \- Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible For Colorectal Cancer Participants: \- Has received 2 prior lines of therapy For GBM Participants: * Has failed initial systemic therapy for newly diagnosed GBM * Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines * Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable * Has histologically confirmed World Health Organization (WHO) Grade IV GBM * Has locally determined result for O\^6-methylguanine-DNA methyltransferase (MGMT) analysis For Biliary Tract Cancer Participants: * Has received 1 prior line of therapy * Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6 For Pancreatic Cancer Participants: * Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment * Has received one or 2 prior lines of therapy * Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer Exclusion Criteria: * Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib * Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort) * Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment * Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment * Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability * Has a history of arterial thromboembolism within 12 months of start of study treatment * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has a serious nonhealing wound, ulcer or bone fracture * Has had major surgery within 3 weeks prior to first dose of study interventions * Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry * Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula * Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], Tumor necrosis factor receptor superfamily, member 4 \[OX 40\], tumor necrosis factor receptor superfamily member 9 \[CD137\]) * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start * If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment * Has received prior radiotherapy within 2 weeks of start of study treatment. 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-central nervous system (CNS) disease * Has received a live vaccine within 30 days prior to the first dose of study treatment * Has known intolerance to lenvatinib (and/or any of the excipients) * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment * 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 treatment * Has known active CNS metastases and/or carcinomatous meningitis * Has tumors involving the brain stem * 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 (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 known history of active tuberculosis (TB; Bacillus tuberculosis) * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment * Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection) For GBM Participants: * Has carcinomatous meningitis * Has recurrent tumor greater than 6 cm in maximum diameter * Has tumor primarily localized to the brainstem or spinal cord * Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease * Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans * Has received Optune® TTFields within 2 weeks of study intervention

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 biliary tract cancer Biliary Tract Neoplasms colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm glioblastoma malignant pancreatic neoplasm ovarian cancer pancreatic neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced solid tumors Biliary tract cancers Colorectal cancer Gastric cancer Glioblastoma Ovarian cancer Pancreatic cancer Triple-negative breast cancer

Contacts and locations

Locations

  • Alfred Health ( Site 0902)

    Melbourne, Victoria, 3004, Australia

  • Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

    Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

  • Asan Medical Center ( Site 1002)

    Songpagu, Seoul, 05505, South Korea

  • BC Cancer - Abbotsford ( Site 0200)

    Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

  • CEMIC ( Site 2104)

    Buenos Aires, C1431FWO, Argentina

  • CHU de Quebec Universite de Laval ( Site 0206)

    Québec, Quebec, G1R 2J6, Canada

  • Cambridge University Hospitals NHS Trust ( Site 0803)

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • CancerCare Manitoba ( Site 0201)

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cedars Sinai Medical Center ( Site 0003)

    Los Angeles, California, 90048, United States

  • Centre Antoine Lacassagne ( Site 0404)

    Nice, Alpes-Maritimes, 06189, France

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Leon Berard ( Site 0405)

    Lyon, Auvergne, 69373, France

  • Centre Oscar Lambret ( Site 0401)

    Lille, Nord, 59000, France

  • Centro Investigación del Cáncer James Lind ( Site 1203)

    Temuco, Araucania, 4780000, Chile

  • Chaim Sheba Medical Center ( Site 0600)

    Ramat Gan, 5262000, Israel

  • Christie NHS Foundation Trust ( Site 0805)

    Manchester, M20 4BX, United Kingdom

  • Chulalongkorn University ( Site 5001)

    Bangkok, Bangkok, 10330, Thailand

  • City Clinical Oncology Center ( Site 1608)

    Saint Petersburg, Sankt-Peterburg, 198255, Russia

  • City of Hope ( Site 0002)

    Duarte, California, 91010, United States

  • Clinica Universitaria de Navarra ( Site 0704)

    Madrid, 28027, Spain

  • Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

    Roma, 00168, Italy

  • Fundacion Arturo Lopez Perez ( Site 1201)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

    Medellín, Antioquia, 050030, Colombia

  • Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1078AAI, Argentina

  • Fundacion Valle del Lili ( Site 1101)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Guy's Hospital ( Site 0806)

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

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

    Wiesbaden, Hesse, 65199, Germany

  • Hadassah Ein Kerem Medical Center ( Site 0604)

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

    Hamilton, Ontario, L8V 4X2, Canada

  • Hopitaux Universitaires de Geneve HUG ( Site 1701)

    Geneva, 1211, Switzerland

  • Hospital Aleman ( Site 2100)

    Buenos Aires, Buenos Aires F.D., 1118, Argentina

  • Hospital Britanico de Buenos Aires ( Site 2109)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

  • Hospital Clinic i Provincial ( Site 0703)

    Barcelona, 08036, Spain

  • Hospital Clinico Universidad de Chile ( Site 1200)

    Santiago, Region M. de Santiago, 8380456, Chile

  • Hospital Ramon y Cajal ( Site 0702)

    Madrid, 28034, Spain

  • Hospital Universitario Gregorio Maranon ( Site 0701)

    Madrid, 28009, Spain

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

    Caba, C1012AAR, Argentina

  • Inselspital Universitaetsspital Bern ( Site 1705)

    Bern, Canton of Bern, 3010, Switzerland

  • Institut Claudius Regaud IUCT Oncopole ( Site 0403)

    Toulouse, Haute-Garonne, 31059, France

  • Institut Gustave Roussy ( Site 0400)

    Villejuif, Val-de-Marne, 94800, France

  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

    Saint-Herblain, Val-de-Marne, 44805, France

  • Instituto Nacional de Cancerologia E.S.E ( Site 1102)

    Bogotá, Bogota D.C., 110321, Colombia

  • Instituto de Oncologia de Rosario ( Site 2105)

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Istituto Clinico Humanitas Research Hospital ( Site 1402)

    Rozzano, Milano, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

    Naples, 80131, Italy

  • Kantonsspital Graubuenden ( Site 1704)

    Chur, Kanton Graubünden, 7000, Switzerland

  • Kantonsspital St. Gallen ( Site 1702)

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

    New York, New York, 10016, United States

  • Lehigh Valley Hospital- Cedar Crest ( Site 0047)

    Allentown, Pennsylvania, 18103, United States

  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Leningrad Regional Oncology Center ( Site 1609)

    Saint Petersburg, Sankt-Peterburg, 188663, Russia

  • Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

    Dallas, Texas, 75230, United States

  • National Cheng Kung University Hospital ( Site 3003)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 3000)

    Taipei, 10002, Taiwan

  • Oncologos del Occidente S.A. ( Site 1106)

    Pereira, Risaralda Department, 660001, Colombia

  • Ospedale Regionale di Bellinzona e Valli ( Site 1703)

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Policlinico Le Scotte - A.O. Senese ( Site 1401)

    Siena, Tuscany, 53100, Italy

  • Pontificia Universidad Catolica de Chile ( Site 1202)

    Santiago, Region M. de Santiago, 8330024, Chile

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario, M5G 2M9, Canada

  • Ramathibodi Hospital. ( Site 5002)

    Bangkok, Bangkok, 10400, Thailand

  • Rambam Medical Center ( Site 0602)

    Haifa, 3109601, Israel

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

    Kazan', Tatarstan, Respublika, 420029, Russia

  • Robert Bosch GmbH ( Site 0307)

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Royal Brisbane and Women s Hospital ( Site 0901)

    Herston, Queensland, 4029, Australia

  • Royal Marsden Hospital (Sutton) ( Site 0800)

    London, Surrey, SM3 5PT, United Kingdom

  • Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

    Moscow, Moscow, 115478, Russia

  • Rutgers Cancer Institute of New Jersey ( Site 0009)

    New Brunswick, New Jersey, 08901, United States

  • SRH Wald-Klinikum Gera GmbH ( Site 0309)

    Gera, Thuringia, 07548, Germany

  • Sanford Cancer Center ( Site 0058)

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Fargo Medical Center ( Site 0059)

    Fargo, North Dakota, 58102, United States

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Seoul National University Hospital ( Site 1000)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 1001)

    Seoul, 03722, South Korea

  • Sir Charles Gairdner Hospital ( Site 0903)

    Nedlands, Western Australia, 6009, Australia

  • Siriraj Hospital ( Site 5003)

    Bangkok, Bangkok, 10700, Thailand

  • Soroka Medical Center ( Site 0601)

    Beersheba, 8457108, Israel

  • Sourasky Medical Center ( Site 0603)

    Tel Aviv, 6423906, Israel

  • Sunnybrook Research Institute ( Site 0207)

    Toronto, Ontario, M4N 3M5, Canada

  • Swedish Medical Center ( Site 0021)

    Seattle, Washington, 98104, United States

  • Universitaetsklinikum Frankfurt ( Site 0306)

    Frankfurt am Main, Hesse, 60528, Germany

  • Universitaetsklinikum Jena ( Site 0302)

    Jena, Thuringia, 07740, Germany

  • Universitaetsklinikum Regensburg ( Site 0304)

    Regensburg, Bavaria, 93053, Germany

  • Universitaetsspital Zurich ( Site 1700)

    Zurich, 8091, Switzerland

  • University of California Davis Comprehensive Cancer Center ( Site 0005)

    Sacramento, California, 95817, United States

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

    Aurora, Colorado, 80045, United States

  • University of Florida-Health Cancer Center-Orlando ( Site 0015)

    Orlando, Florida, 32806, United States

  • University of Wisconsin Carbone Cancer Center ( Site 0017)

    Madison, Wisconsin, 53792-0001, United States

  • West Cancer Center - East Campus ( Site 0018)

    Germantown, Tennessee, 38138, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.