EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma

ConditionNeoplasms of Bone and Articular Cartilage With Unspecified Anatomical Site

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age15-79

SponsorYonsei University

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed advanced Osteosarcoma, Ewing sarcoma, Chondrosarcoma with 1-2 prior chemotherapy

Age ≥19 years, <80 years

ECOG performance status of 0-1

Has at least 1 measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors Version 1.1).

Disqualifiers

Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable

Any previous treatment to lenvatinib or mTOR inhibitor

Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of IP ⑤Active or prior documented autoimmune or inflammatory disorders

Trial design

Treatments tested in this trial

Everolimus and Lenvatinib
Everolimus

Treatment groups

94 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Yonsei University

Lead sponsor

Source ClinicalTrials.gov