Last updated on March 2020

Trial of Sunitinib Plus Nivolumab After Standard Treatment in Advanced Soft Tissue and Bone Sarcomas


Brief description of study

Phase I-II, single-arm, non-randomized, open-label, multicenter, international clinical trial, with two cohorts (Soft Tissue Sarcoma and Bone Sarcoma). Seven sites in Spain, 3 sites in Italy and 1 site in the United Kingdom.

Adult patients will receive an initial induction phase from day 1 to day 14 of sunitinib 37.5 mg/day followed by a maintenance phase of sunitinib 25mg/day orally continuously + nivolumab 240mg intravenous every 2 weeks infused over 1 hour. Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

Pediatric patients will receive an initial induction phase from day 1 to day 14 of sunitinib 25 mg/day, or 37.5 mg/day if BSA > 1.7, followed by a maintenance phase of sunitinib 25mg/day orally continuously + nivolumab 240mg intravenous every 2 weeks infused over 1 hour. Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

The main goal is to evaluate the efficacy of the sunitinib plus nivolumab combination as measured by the progression-free survival rate (PFSR) at 6 months in patients with advanced soft tissue and bone sarcomas.

Detailed Study Description

One arm survival design based on Lawless (Lawless, Statistical Models and Methods for Lifetime Data, John Wiley and Sons, 2003). Formulas are based on the assumptions of uniform accrual over time, no loss to follow-up, exponentially distributed death times.

For STS 2nd line cohort sample size has been obtained for the primary endpoint progression-free survival rate (PFSR) at 6 months. Estimated accrual time: 24 months. A PFSR of 5% will be considered not promising, whereas a PFSRof 15% will be considered promising in this population. With a type I error of 0.05 and a power of 0.90, 43 patients are needed in this cohort.

For bone sarcoma 2nd line cohort sample size has been obtained under the same assumptions than above, but with a type I error of 0.10, therefore 32 patients are needed in this cohort.

Clinical Study Identifier: NCT03277924

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