Relapsed or Refractory Solid TumorsPhase 2E7080-G000-231NCT04447755
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
A Phase 2 study testing Lenvatinib in people with Relapsed or Refractory Solid Tumors, run by Merck Sharp & Dohme LLC at 49 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Relapsed or Refractory Solid Tumors
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 49 sitesin 20 countries
- Study dates
- 30 Jul 2020to 13 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
49 sites in 20 countries.
49 sites in 20 countries
Italy5 sites
A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)
Florence, Tuscany, 50139
Istituto Giannina Gaslini ( Site 0411)
Genova, 16147
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)
Milan, 20133
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)
Rome, Roma, 00165
Ospedale Infantile Regina Margherita ( Site 0412)
Torino, 10126
United States4 sites
Children's Hospital of Colorado ( Site 0110)
Aurora, Colorado, 80045
Cleveland Clinic ( Site 0119)
Cleveland, Ohio, 44195
Mary Crowley Cancer Research Center ( Site 0107)
Dallas, Texas, 75230
Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)
Nashville, Tennessee, 37232
Australia4 sites
Queensland Children s Hospital ( Site 0804)
Brisbane, Queensland, 4101
Perth Children s Hospital ( Site 0803)
Nedlands, Western Australia, 6009
Royal Childrens Hospital Melbourne ( Site 0802)
Parkville, Victoria, 3052
Sydney Children's Hospital ( Site 0801)
Randwick, New South Wales, 2031
France4 sites
Centre Leon-Berard ( Site 0326)
Lyon, Auvergne, 69008
Hopital La Timone ( Site 0328)
Marseille, Bouches-du-Rhone, 13005
Institut Curie ( Site 0325)
Paris, 75005
Gustave Roussy ( Site 0327)
Villejuif, Val-de-Marne, 94800
Turkey (Türkiye)4 sites
Hacettepe Universitesi Tip Fakultesi ( Site 0603)
Ankara, 06100
Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)
Istanbul, 34093
Ege Universitesi Tip Fakultesi ( Site 0601)
Izmir, 35040
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)
Izmir, 35330
Hungary3 sites
Semmelweis University ( Site 0675)
Budapest, 1094
Debreceni Egyetem Klinikai Kozpont ( Site 0677)
Debrecen, 4032
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)
Miskolc, Borsod-Abauj Zemplen county, 3526
Russia3 sites
Dmitry Rogachev National Research Center ( Site 0550)
Moscow, Moscow, 117198
St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)
Saint Petersburg, Sankt-Peterburg, 197022
Clinical Research Center of specialized types medical care-Oncology ( Site 0553)
Saint Petersburg, Sankt-Peterburg, 197758
South Africa3 sites
Cancercare Rondebosch Oncology ( Site 0575)
Cape Town, Western Cape, 7700
Tygerberg Hospital ( Site 0578)
Parow, Western Cape, 7505
Wits Clinical Research ( Site 0579)
Soweto, Gauteng, 2013
Argentina2 sites
Hospital de Niños Ricardo Gutiérrez ( Site 0125)
Buenos Aires, Buenos Aires F.D., C1425EFD
Hospital Universitario Austral ( Site 0126)
Pilar, Buenos Aires, B1629ODT
Croatia2 sites
Klinicki bolnicki centar Rijeka ( Site 0726)
Rijeka, Primorje-Gorski Kotar County, 51000
Klinika za djecje bolesti Zagreb ( Site 0725)
Zagreb, Zagreb County, 10000
Czechia2 sites
Fakultni Nemocnice Brno Bohunice ( Site 0651)
Brno, Brno-mesto, 613 00
Fakultni nemocnice v Motole ( Site 0650)
Prague, 150 06
Guatemala2 sites
Unidad Nacional de Oncologia Pediatrica ( Site 0176)
Guatemala City, 01011
Medi-K Cayala ( Site 0177)
Guatemala City, 01016
Serbia2 sites
Institute for Oncology and Radiology of Serbia ( Site 0780)
Belgrade, Beograd, 11000
Univerzitetska decja klinika ( Site 0782)
Belgrade, Beograd, 11000
South Korea2 sites
Seoul National University Hospital ( Site 0875)
Seoul, 03080
Asan Medical Center ( Site 0876)
Songpagu, Seoul, 05505
Spain2 sites
Hospital Universitario Sant Joan de Deu ( Site 0476)
Esplugues de Llobregat, Barcelona, 08950
Hospital Nino Jesus ( Site 0477)
Madrid, 28009
Sweden1 site
Skanes Universitetssjukhus Lund. ( Site 0525)
Lund, Skåne County, 221 85
About this study
Official title: An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies
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
- Being tested
- Lenvatinib
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called MK-7902, E7080, LENVIMA
Lenvatinib capsules administered orally at 14 mg/m^2 QD
| Study group | Role | What they receive |
|---|---|---|
| Ewing Sarcoma | Experimental | Participants with Ewing sarcoma will receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity. Receives: Drug: Lenvatinib |
| Rhabdomyosarcoma | Experimental | Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. Receives: 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. Receives: 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. Receives: Drug: Lenvatinib |
| Medulloblastoma | Experimental | Participants with medulloblastoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. Receives: Drug: Lenvatinib |
| Ependymoma | Experimental | Participants with ependymoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. Receives: 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. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 weeks
Secondary outcomes (14)
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
ORR 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 SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response was assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Measured: Up to approximately 21 months
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).
Measured: Up to approximately 21 months
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Measured: Up to approximately 21 months
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Measured: Up to approximately 21 months
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DCR was defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
Measured: Up to approximately 21 months
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
Measured: Up to approximately 21 months
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced at least one AE is reported.
Measured: Up to approximately 50 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported.
Measured: Up to approximately 38 months
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the supplemental Statistical Analysis Plan (sSAP), all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the taste category is presented.
Measured: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the appearance category is presented.
Measured: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the smell category is presented.
Measured: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the mouth feel category is presented.
Measured: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the overall acceptability category is presented.
Measured: Cycle 1 Day 1 (cycle = 28 days)
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.
Measured: Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jul 2020
- Primary completion16 Sep 2022
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Solid TumorsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447755
- Sponsor's protocol ID
- 7902-013
- Other IDs
- MK-7902-013, HopSkip-013, 2024-512135-80-00, U1111-1304-6856, 2019-004441-33, 2019
- Acronym
- E7080-G000-231
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2020
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 34562750
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies
- ClinicalTrials.gov ID
- NCT04447755
- Acronym / sponsor ID
- E7080-G000-231 / 7902-013
- Conditions
- Relapsed or Refractory Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Ewing Sarcoma | Experimental | Drug: LenvatinibParticipants with Ewing sarcoma will receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity. |
| Rhabdomyosarcoma | Experimental | Drug: LenvatinibParticipants with rhabdomyosarcoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
| High Grade Glioma | Experimental | Drug: LenvatinibParticipants with high grade glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
| Diffuse Midline Glioma | Experimental | Drug: LenvatinibParticipants with diffuse midline glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
| Medulloblastoma | Experimental | Drug: LenvatinibParticipants with medulloblastoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
| Ependymoma | Experimental | Drug: LenvatinibParticipants with ependymoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
| Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | Experimental | Drug: LenvatinibParticipants with other solid tumors will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: MK-7902, E7080, LENVIMALenvatinib capsules administered orally at 14 mg/m^2 QD | Drug | Diffuse Midline Glioma, Ependymoma, Ewing Sarcoma, High Grade Glioma, Medulloblastoma, Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma, Rhabdomyosarcoma |
Primary outcome
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
Time frame: Up to 16 weeks
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.
14 secondary outcomes
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time frame: Up to approximately 21 months
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 50 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to approximately 38 months
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
Time frame: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
Time frame: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
Time frame: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
Time frame: Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
Time frame: Cycle 1 Day 1 (cycle = 28 days)
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Time frame: Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34562750Gaspar 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.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
49 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib in people with Relapsed or Refractory Solid Tumors, run by Merck Sharp & Dohme LLC at 49 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Italy, United States, Australia, France, Turkey (Türkiye) and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.