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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Everolimus and Lenvatinib

    Drug

    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

    Drug

    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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: ComboExperimental treatment 1 intervention
Group B: MonoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free rate (PFR6)

Progression free rate (PFR-6) at 24 weeks will be based on RECIST version 1.1

Time frame
up to 3 years

Secondary outcomes

1

Progression-free survival (PFS)

The earlier of the date of first documented progressive disease or death from the date of enrollment

Time frame
up to 3 years
2

Overall survival (OS)

From the date of treatment initiation to the date of death or last follow-up

Time frame
up to 3 years
3

Number of participants with treatment-related adverse events

Number of participants with treatment-related adverse events: Adverse events considered related to study treatment will be assessed according to CTCAE version 5.0.

Time frame
up to 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: