A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)

NCT04447755 | Completed Phase 2 Results DMC FDA Drug

• 6 other identifiers: 7902-013MK-7902-013HopSkip-0132024-512135-80-00U1111-1304-68562019-004441-33
• Study Type: interventional
• Target: 127
• Locations: 19 countries
• Sites: 47

Brief Summary

The main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants were enrolled into Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), high-grade glioma (HGG), diffuse midline glioma, medulloblastoma, ependymoma, and Other Solid Tumors Excluding Osteosarcoma, diffuse midline glioma, medulloblastoma, and ependymoma cohorts.

Conditions

Relapsed or Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment

  ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

  Up to 16 weeks

Secondary Outcomes (14)

• ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment

  Up to approximately 21 months

• Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment

  Up to approximately 21 months

• Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment

  Up to approximately 21 months

• Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment

  Up to approximately 21 months

• Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment

  Up to approximately 21 months

Study Arms (7)

Ewing Sarcoma

EXPERIMENTAL

Participants with Ewing sarcoma will receive lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Rhabdomyosarcoma

EXPERIMENTAL

Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

High Grade Glioma

EXPERIMENTAL

Participants with high grade glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Diffuse Midline Glioma

EXPERIMENTAL

Participants with diffuse midline glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Medulloblastoma

EXPERIMENTAL

Participants with medulloblastoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Ependymoma

EXPERIMENTAL

Participants with ependymoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma

EXPERIMENTAL

Participants with other solid tumors will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

Lenvatinib capsules administered orally at 14 mg/m\^2 QD

Also known as: MK-7902, E7080, LENVIMA

Diffuse Midline Glioma; Ependymoma; Ewing Sarcoma; High Grade Glioma; Medulloblastoma; Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma; Rhabdomyosarcoma

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (49)

Children's Hospital of Colorado ( Site 0110)

Aurora, Colorado, 80045, United States

Location

Cleveland Clinic ( Site 0119)

Cleveland, Ohio, 44195, United States

Location

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

Nashville, Tennessee, 37232, United States

Location

Mary Crowley Cancer Research Center ( Site 0107)

Dallas, Texas, 75230, United States

Location

Hospital Universitario Austral ( Site 0126)

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Hospital de Niños Ricardo Gutiérrez ( Site 0125)

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

Location

Sydney Children's Hospital ( Site 0801)

Randwick, New South Wales, 2031, Australia

Location

Queensland Children s Hospital ( Site 0804)

Brisbane, Queensland, 4101, Australia

Location

Royal Childrens Hospital Melbourne ( Site 0802)

Parkville, Victoria, 3052, Australia

Location

Perth Children s Hospital ( Site 0803)

Nedlands, Western Australia, 6009, Australia

Location

UZ Gent ( Site 0250)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Klinicki bolnicki centar Rijeka ( Site 0726)

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

Klinika za djecje bolesti Zagreb ( Site 0725)

Zagreb, Zagreb County, 10000, Croatia

Location

Fakultni Nemocnice Brno Bohunice ( Site 0651)

Brno, Brno-mesto, 613 00, Czechia

Location

Fakultni nemocnice v Motole ( Site 0650)

Prague, 150 06, Czechia

Location

Centre Leon-Berard ( Site 0326)

Lyon, Auvergne, 69008, France

Location

Hopital La Timone ( Site 0328)

Marseille, Bouches-du-Rhone, 13005, France

Location

Gustave Roussy ( Site 0327)

Villejuif, Val-de-Marne, 94800, France

Location

Institut Curie ( Site 0325)

Paris, 75005, France

Location

Unidad Nacional de Oncologia Pediatrica ( Site 0176)

Guatemala City, 01011, Guatemala

Location

Medi-K Cayala ( Site 0177)

Guatemala City, 01016, Guatemala

Location

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Semmelweis University ( Site 0675)

Budapest, 1094, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 0677)

Debrecen, 4032, Hungary

Location

Chaim Sheba Medical Center ( Site 0500)

Ramat Gan, 5265601, Israel

Location

IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)

Rome, Roma, 00165, Italy

Location

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

Florence, Tuscany, 50139, Italy

Location

Istituto Giannina Gaslini ( Site 0411)

Genova, 16147, Italy

Location

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

Milan, 20133, Italy

Location

Ospedale Infantile Regina Margherita ( Site 0412)

Torino, 10126, Italy

Location

Starship Childrens Hospital ( Site 0826)

Auckland, 1023, New Zealand

Location

Clinica Anglo Americana ( Site 0203)

San Isidro, Lima region, 15073, Peru

Location

Dmitry Rogachev National Research Center ( Site 0550)

Moscow, Moscow, 117198, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Institute for Oncology and Radiology of Serbia ( Site 0780)

Belgrade, Beograd, 11000, Serbia

Location

Univerzitetska decja klinika ( Site 0782)

Belgrade, Beograd, 11000, Serbia

Location

Wits Clinical Research ( Site 0579)

Soweto, Gauteng, 2013, South Africa

Location

Cancercare Rondebosch Oncology ( Site 0575)

Cape Town, Western Cape, 7700, South Africa

Location

Tygerberg Hospital ( Site 0578)

Parow, Western Cape, 7505, South Africa

Location

Asan Medical Center ( Site 0876)

Songpagu, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 0875)

Seoul, 03080, South Korea

Location

Hospital Universitario Sant Joan de Deu ( Site 0476)

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Nino Jesus ( Site 0477)

Madrid, 28009, Spain

Location

Skanes Universitetssjukhus Lund. ( Site 0525)

Lund, Skåne County, 221 85, Sweden

Location

Hacettepe Universitesi Tip Fakultesi ( Site 0603)

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)

Istanbul, 34093, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi ( Site 0601)

Izmir, 35040, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)

Izmir, 35330, Turkey (Türkiye)

Location

Related Publications (1)

• Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

  PMID: 34562750 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Recurrence

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: July 30, 2020
• Primary Completion: September 16, 2022
• Study Completion: February 13, 2025
• Last Updated: October 3, 2025
• Results First Posted: October 4, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AR (2); AU (4); IL (1); NZ (1); FR (4); ZA (3); US (4); TU (4); GU (2); IT (5); ES (2); KR (2); SE (1); CZ (2); PE (1); BE (1); CR (2); HU (3); RU (3)