Lenvatinib for Solid Tumors in Pediatric Patients

(E7080-G000-231 Trial)

Recruiting at 48 trial locations

Overseen By Toll Free Number

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Antihypertensives

Disqualifiers: HIV, Hepatitis B/C, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

127 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for children, adolescents, and young adults with certain types of solid tumors that have come back or didn't respond to treatment. They must be able to perform daily activities at a certain level, have measurable tumor growth, stable organ function including heart and kidneys, controlled blood pressure, no serious infections or HIV, not pregnant or breastfeeding (if applicable), and agree to use contraception.

Inclusion Criteria

I agree to use contraception and not donate sperm during and for 7 days after treatment.

I can do most activities, and if I have a brain tumor, my condition has been stable for at least a week.

I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.

Exclusion Criteria

My scans show cancer affecting major blood vessels or has caused holes in the tumor.

I have a severe fistula in my GI tract or elsewhere.

I am currently being treated for an infection.

Treatment Details

Interventions

• Lenvatinib

Trial Overview The study tests Lenvatinib's effectiveness in shrinking tumors and its safety in young patients with relapsed/refractory solid malignancies. Participants are grouped based on their specific type of cancer and will receive the drug while being monitored for response.

Participant Groups

Group I: Rhabdomyosarcoma Experimental Treatment 1 Intervention

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

Group II: Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Experimental Treatment 1 Intervention

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

Group III: Medulloblastoma Experimental Treatment 1 Intervention

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

Group IV: High Grade Glioma Experimental Treatment 1 Intervention

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

Group V: Ewing Sarcoma Experimental Treatment 1 Intervention

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

Group VI: Ependymoma Experimental Treatment 1 Intervention

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

Group VII: Diffuse Midline Glioma Experimental Treatment 1 Intervention

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

Lenvatinib is already approved in United States, European Union for the following indications:

Approved in United States as Lenvima for:

• Differentiated Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Lenvima for:

• Thyroid Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Endometrial Cancer

Approved in European Union as Kisplyx for:

• Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University