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New hope for young cancer patients: drug shows promise against tough tumors

NCT ID NCT04447755

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the drug lenvatinib in 127 children, adolescents, and young adults whose solid tumors had come back or stopped responding to treatment. The goal was to see if the drug could shrink tumors and to check for side effects. Participants received lenvatinib daily, and doctors measured tumor response after 16 weeks using standard criteria.

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

127 people

The number who actually took part.

Started

Jul 2020

Finished

Feb 2025

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

2 to 21 years

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 documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma * Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG) * Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants \>16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment * Demonstrate adequate organ function * No clinical evidence of nephrotic syndrome. * Has adequate blood pressure (BP) control with or without antihypertensive medications * Has adequate cardiac function * Has adequate neurologic function * Participant must have fully recovered to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy * Male participants must agree to use approved contraception during the treatment period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period * Female participants are not pregnant and not breastfeeding, and are not a woman of childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention Exclusion Criteria: * Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1) * Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment * Has CNS tumors with a history of symptomatic tumor hemorrhage * Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment * Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation * Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease. * Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib * Has preexisting ≥Grade 3 GI or non-GI fistula * Has any active infection requiring systemic therapy * Known to be Human immunodeficiency virus (HIV) positive * Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing for hepatitis B or hepatitis C is required at screening only when mandated by local health authority * Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation * 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 known hypersensitivity to any component of the investigational product (lenvatinib or ingredients) * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the stud * Has clinically significant cardiovascular disease within 6 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 non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment

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Conditions

The condition(s) this trial relates to.

diffuse intrinsic pontine glioma ependymoma Ewing sarcoma malignant glioma medulloblastoma Recurrence refractory malignant neoplasm rhabdomyosarcoma

As listed by the trial registrant

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

Relapsed or refractory solid tumors

Contacts and locations

Locations

  • A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)

    Florence, Tuscany, 50139, Italy

  • Asan Medical Center ( Site 0876)

    Songpagu, Seoul, 05505, South Korea

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • Cancercare Rondebosch Oncology ( Site 0575)

    Cape Town, Western Cape, 7700, South Africa

  • Centre Leon-Berard ( Site 0326)

    Lyon, Auvergne, 69008, France

  • Chaim Sheba Medical Center ( Site 0500)

    Ramat Gan, 5265601, Israel

  • Children's Hospital of Colorado ( Site 0110)

    Aurora, Colorado, 80045, United States

  • Cleveland Clinic ( Site 0119)

    Cleveland, Ohio, 44195, United States

  • Clinica Anglo Americana ( Site 0203)

    San Isidro, Lima region, 15073, Peru

  • Clinical Research Center of specialized types medical care-Oncology ( Site 0553)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Debreceni Egyetem Klinikai Kozpont ( Site 0677)

    Debrecen, 4032, Hungary

  • Dmitry Rogachev National Research Center ( Site 0550)

    Moscow, Moscow, 117198, Russia

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)

    Izmir, 35330, Turkey (Türkiye)

  • Ege Universitesi Tip Fakultesi ( Site 0601)

    Izmir, 35040, Turkey (Türkiye)

  • Fakultni Nemocnice Brno Bohunice ( Site 0651)

    Brno, Brno-mesto, 613 00, Czechia

  • Fakultni nemocnice v Motole ( Site 0650)

    Prague, 150 06, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)

    Milan, 20133, Italy

  • Gustave Roussy ( Site 0327)

    Villejuif, Val-de-Marne, 94800, France

  • Hacettepe Universitesi Tip Fakultesi ( Site 0603)

    Ankara, 06100, Turkey (Türkiye)

  • Hopital La Timone ( Site 0328)

    Marseille, Bouches-du-Rhone, 13005, France

  • Hospital Nino Jesus ( Site 0477)

    Madrid, 28009, Spain

  • Hospital Universitario Austral ( Site 0126)

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Hospital Universitario Sant Joan de Deu ( Site 0476)

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital de Niños Ricardo Gutiérrez ( Site 0125)

    Buenos Aires, Buenos Aires F.D., C1425EFD, Argentina

  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)

    Rome, Roma, 00165, Italy

  • Institut Curie ( Site 0325)

    Paris, 75005, France

  • Institute for Oncology and Radiology of Serbia ( Site 0780)

    Belgrade, Beograd, 11000, Serbia

  • Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Giannina Gaslini ( Site 0411)

    Genova, 16147, Italy

  • Klinicki bolnicki centar Rijeka ( Site 0726)

    Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

  • Klinika za djecje bolesti Zagreb ( Site 0725)

    Zagreb, Zagreb County, 10000, Croatia

  • Mary Crowley Cancer Research Center ( Site 0107)

    Dallas, Texas, 75230, United States

  • Medi-K Cayala ( Site 0177)

    Guatemala City, 01016, Guatemala

  • Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)

    Nashville, Tennessee, 37232, United States

  • Ospedale Infantile Regina Margherita ( Site 0412)

    Torino, 10126, Italy

  • Perth Children s Hospital ( Site 0803)

    Nedlands, Western Australia, 6009, Australia

  • Queensland Children s Hospital ( Site 0804)

    Brisbane, Queensland, 4101, Australia

  • Royal Childrens Hospital Melbourne ( Site 0802)

    Parkville, Victoria, 3052, Australia

  • Semmelweis University ( Site 0675)

    Budapest, 1094, Hungary

  • Seoul National University Hospital ( Site 0875)

    Seoul, 03080, South Korea

  • Skanes Universitetssjukhus Lund. ( Site 0525)

    Lund, Skåne County, 221 85, Sweden

  • St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Starship Childrens Hospital ( Site 0826)

    Auckland, 1023, New Zealand

  • Sydney Children's Hospital ( Site 0801)

    Randwick, New South Wales, 2031, Australia

  • Tygerberg Hospital ( Site 0578)

    Parow, Western Cape, 7505, South Africa

  • UZ Gent ( Site 0250)

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Unidad Nacional de Oncologia Pediatrica ( Site 0176)

    Guatemala City, 01011, Guatemala

  • Univerzitetska decja klinika ( Site 0782)

    Belgrade, Beograd, 11000, Serbia

  • Wits Clinical Research ( Site 0579)

    Soweto, Gauteng, 2013, South Africa

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