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

  • STATUS
    Recruiting
  • End date
    Feb 19, 2024
  • participants needed
    150
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 16 September 2021

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 will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.

Details
Condition Relapsed or Refractory Solid Tumors
Treatment Lenvatinib
Clinical Study IdentifierNCT04447755
SponsorMerck Sharp & Dohme Corp.
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

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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