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EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma
Sponsor: Yonsei University
Summary
Those studies demonstrate strong rationale to combine a multikinase inhibitor targeting VEGFR, PDGFR with mTOR inhibitor. Moreover, another multi-targeted TKI, lenvatinib monotherapy showed promising activity in osteosarcoma. Therefore, clinical trial with Lenvatinib in combined with everolimus is ongoing for solid tumors (NCT03245151). Considering lenvatinib and everolimus (18 mg/day and 5 mg/day) already approved as standard treatment for renal cell carcinoma based on the powerful ORR, PFS, and OS14, these noteworthy findings advance the treatment paradigm for bone sarcoma patients. Because all those trials for sarcoma were done in the absence of a control group, based on such clinical studies, a confirmatory trial comparing mTOR inhibitor and a multi-targeted tyrosine kinase inhibitor (multi-TKI) combination versus monotherapy is essential. Therefore, we planned to conduct the randomized phase II trial of everolimus in combination with lenvatinib for advanced/metastatic bone sarcomas. In addition, we will explore predictive biomarkers by repeated biopsies and blood samplings during the treatment.
Official title: EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Progressing After Standard Treatmen : a Randomized, Phase 2, Multi-center Trial [EVERLAST]
Key Details
Gender
All
Age Range
15 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-07-01
Completion Date
2028-11-30
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
Everolimus and Lenvatinib
Everolimus (5 mg) and Lenvatinib (14 mg) will be administered orally once daily (QD) in continuous 28-day cycles. In subjects who maintain toxicity at Grade ≤2 during the initial 4-week period (Cycle 1), the Lenvatinib dose may be escalated to 18 mg QD beginning in Cycle 2, at the discretion of the investigator
Everolimus
Everolimus (10 mg) will be administered orally once daily (QD) as monotherapy in continuous 28-day cycles. Upon radiologic or clinical disease progression, subjects may switch to Lenvatinib (24 mg) monotherapy, administered orally once daily (QD) in 28-day cycles.