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

STATUS

Recruiting
participants needed

150
sponsor

Merck Sharp & Dohme Corp.

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Updated on 19 February 2024

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cancer

measurable disease

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cancer treatment

neuropathy

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lenvatinib

antihypertensive agents

pediatric

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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
Age	2years - 21years
Treatment	Lenvatinib
Clinical Study Identifier	NCT04447755
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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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 30 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
	Is a WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention
	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
	A clinically significant ECG abnormality, including a marked baseline prolonged QT or QT interval corrected for heart rate (QTc) interval (eg, a repeated demonstration of a QTc interval >480 msec)
	Known to be Human immunodeficiency virus (HIV) positive
	Active viral hepatitis (B or C) as demonstrated by positive serology
	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 study

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