RecruitingPhase 2NCT04874311

Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma

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


Sponsor

Institut Bergonié

Enrollment

80 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the combination of bintrafusp alfa (an immunotherapy drug that targets two immune checkpoints at once) plus doxorubicin (a chemotherapy) as a first-line treatment for advanced soft-tissue sarcoma (a cancer of connective tissues like muscle, fat, or blood vessels) that cannot be surgically removed or has spread. **You may be eligible if...** - You are 18 or older and have confirmed soft-tissue sarcoma (such as undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, or leiomyosarcoma) - Your cancer has spread or cannot be surgically removed - You have not yet received any systemic (whole-body) treatment for your advanced/metastatic disease - Your overall fitness score is 0 or 1 (ECOG), and your expected survival is more than 3 months - You have at least one measurable tumor and are willing to have biopsies taken - Adequate blood, kidney, and liver function **You may NOT be eligible if...** - You have previously received chemotherapy or other systemic treatment for this advanced stage - You have a different type of sarcoma (e.g., with a known translocation) - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBintrafusp alfa

Bintrafusp alfa will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 2400 mg.

DRUGDoxorubicin

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


Locations(8)

Institut Bergonie

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Institut Paoli Calmette

Marseille, France

Institut Curie

Paris, France

CHU Poitiers

Poitiers, France

IUCT Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT04874311


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