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Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma — TRUST  

Advanced Soft-tissue Sarcoma Clinical Trial

Official title:
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study

Clinical Trial Summary

This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin

Clinical Trial Description

This is a two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (2:1) phase II trials. Patients satisfying eligibility criteria will first be stratified into 2 strata / subgroups: - Soft-tissue sarcoma (STS) patients with an inflamed tumor (i.e. TLS+, defined as presence of mature tertiary lymphoid structures, as per IHC). - Soft-tissue sarcoma patients with a cold tumor (i.e. TLS-, defined as absence of mature tertiary lymphoid structures, as per IHC). - Note: TLS+ and TLS- account for 20% and 80% of STS patients, respectively. STS patients with TLS+ will be randomized between arm A (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm B (doxorubicin for 6 cycles) with two patients randomized in arm A for one patient randomized in arm B. STS patients with TLS- will be randomized between arm C (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm D (doxorubicin for 6 cycles) with two patients randomized in arm C for one patient randomized in arm D. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04874311
Study type Interventional
Source Institut Bergonié
Contact Antoine ITALIANO, MD, PhD
Phone +33556333333
Email a.italiano@bordeaux.unicancer.fr
Status Recruiting
Phase Phase 2
Start date March 1, 2022
Completion date March 2025
View Details
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