Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
The present study is an open-label, randomized, controlled, two-arm multi-center study of the
efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in
metastatic or unresectable soft-tissue sarcoma patients.
In the study, 114 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment
(Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).
The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin
(Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured
as progression free survival, as compared to doxorubicin alone (Arm 1).
Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks
thereafter.