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Clinical Trial 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 leiomyosarcoma patients.


Clinical Trial Description

In the study, 122 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 metastatic leiomyosarcoma 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03420014
Study type Interventional
Source Philogen S.p.A.
Contact Teresa Hemmerle, PhD
Phone +39 057717816
Email regulatory@philogen.com
Status Recruiting
Phase Phase 2
Start date December 27, 2018
Completion date December 2025

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