NCT04874311

Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Advanced Soft-tissue Sarcoma
• Metastatic Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Bintrafusp alfa	Bintrafusp alfa will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 2400 mg.
DRUG	Doxorubicin	Doxorubicin will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 75 mg/m² for a maximum of 6 cycles

Timeline

• Start date: 2022-03-01
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2021-05-05
• Last updated: 2025-08-13

Locations

8 sites across 1 country: France