Evidence map›Paper›PMID 40313040›Full record

Trial reportPediatric blood & cancer2025

A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric and Young Adult Solid Tumors.

Filemon S Dela Cruz, Elizabeth Fox, Steven G DuBois, Gregory K Friedman, James M Croop, AeRang Kim, Daniel A Morgenstern, Frank M Balis, Margaret E Macy, Joseph G Pressey and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric blood & cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03245151 (A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03245151 phase1 / phase2completednot on this map

A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

TypeinterventionalSponsorEisai Inc.Ran2017 to 2022Enrolled64ConditionsRecurrent and Refractory Solid TumorsArmsLenvatinib, Everolimus
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Filemon S Dela CruzDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Elizabeth FoxSt. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Steven G DuBoisDana-Farber/Boston Children's Cancer and Blood Disorders Center and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-0882-738X
Gregory K FriedmanDepartment of Pediatrics, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0002-6653-7420
James M CroopPediatric Hematology, Oncology, and Stem Cell Transplant, Riley Hospital for Children, Indianapolis, Indiana, USA.
AeRang KimCenter for Cancer and Blood Disorders, Children's National Hospital, Washington, District of Columbia, USA.
Daniel A MorgensternDepartment of Pediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-4859-1108
Frank M BalisCenter for Childhood Cancer Research, Children's Hospital of Philadelphia Research Institute, Philadelphia, Pennsylvania, USA.
Margaret E MacyDepartment of Pediatrics, University of Colorado and Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0001-6446-9180
Joseph G PresseyCancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID https://orcid.org/0000-0003-1816-3281
Tanya WattDivision of Hematology and Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Julie I KrystalPediatric Hematology-Oncology and Cellular Therapy, Cohen Children's Medical Center, Queens, New York, USA.ORCID https://orcid.org/0000-0002-7997-1015
Kieuhoa T VoDepartment of Pediatrics, University of California San Francisco School of Medicine and UCSF Benioff Children's Hospital, San Francisco, California, USA.ORCID https://orcid.org/0000-0002-9281-7485
Rajen ModyPediatric Hematology Oncology, C. S. Mott Children's Hospital, Ann Arbor, Michigan, USA.
Theodore W LaetschDepartment of Pediatrics, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-8497-3138
Brenda J WeigelDepartment of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Karen O'HaraDeep Human Biology Learning (DHBL), Eisai Ltd., Hatfield, UK.
Cixin S HeBiostatistics, DHBL, Eisai Inc., Nutley, New Jersey, USA.
Jagadeesh AluriClinical Pharmacology Science, DHBL, Eisai Inc., Nutley, New Jersey, USA.
Chinyere E OkparaDeep Human Biology Learning (DHBL), Eisai Ltd., Hatfield, UK.
Julia L Glade BenderDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID https://orcid.org/0000-0001-5316-6440

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Eisai Inc., Nutley, NJ, USAMerck & Co. Inc., Rahway, NJ, USAMerck Sharp & Dohme LLCNCI NIH HHS P30 CA008748Oxford PharmaGenesis Inc.
6 · The paper itself

Abstract

introductionDeveloping targeted therapies with manageable toxicities remains a high priority for pediatric cancer. We sought to determine the recommended Phase 2 dose (RP2D) and evaluate the antitumor activity of lenvatinib+everolimus in children/young adults with select recurrent/refractory solid tumors.

methodsPatients 2-21 years old were eligible. Phase 1 used a rolling-six design. Phase 2 was limited to patients with Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), or high-grade glioma (HGG), and ≤2 prior VEGF/VEGFR-targeted therapies. Primary endpoints included the determination of maximum tolerated dose (MTD), RP2D, safety/toxicity (Phase 1), and objective response rate (ORR) per RECIST version 1.1 (RANO for HGG) at Week 16 (Phase 2).

resultsIn Phase 1, 23 patients received lenvatinib 11 mg/m

conclusionLenvatinib+everolimus has a manageable safety profile in this pediatric population. Despite unmet efficacy endpoints, the antitumor activity observed in RMS and EWS may warrant further study in select pediatric solid tumors. CLINICALTRIALS: GOV NUMBER: NCT03245151.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmGliomaNeoplasm Recurrence, LocalNeoplasmsRhabdomyosarcomaSarcoma, EwingAdolescentAdultChildChild, PreschoolEverolimusFemaleFollow-Up StudiesHumansMaleEverolimuslenvatinibPhenylurea CompoundsQuinolineseverolimusEwing sarcomahigh‐grade gliomalenvatinibpediatric solid tumorsrhabdomyosarcoma

Identifiers

PMID40313040
PMCPMC12716803

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.