Trial of Sunitinib Plus Nivolumab After Standard Treatment in Advanced Soft Tissue and Bone Sarcomas
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
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.