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.
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