Actively Recruiting
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Led by Institut Bergonié · Updated on 2025-08-13
80
Participants Needed
8
Research Sites
278 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft-tissue sarcoma with unknown translocation, confirmed by RRePS Network
- Metastatic or unresectable locally advanced disease
- No previous systemic treatment for advanced/metastatic disease
- Available archived or newly obtained tumor tissue sample for TLS analysis
- Age 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Measurable disease with at least one lesion larger than 10 mm by CT scan
- Willingness to comply with tumor biopsies and biomarker studies
- Adequate blood, kidney, metabolic, and liver function
- Negative pregnancy test for women of childbearing potential within 7 days before randomization
- Agreement to use effective contraception during treatment and for at least 2 months after for women, 4 months for men
- No prior or concurrent malignant disease treated in the last 3 years except certain non-invasive cancers
- Recovery to grade 1 or less from previous treatment side effects except specified exceptions
- Signed informed consent
- Social security compliant with French law
You will not qualify if you...
- Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin, other anthracyclines or investigational PD1, PD-L1, or TGFB1 therapies
- Known central nervous system malignancy
- Women or men of childbearing potential not using effective contraception; pregnant or breastfeeding women
- Participation in other therapeutic studies within 30 days
- Previous enrollment in this study
- Inability to comply with study procedures due to geographical, social, or psychological reasons
- Known allergy to study drugs or their components
- History of anaphylaxis or recent uncontrolled asthma
- Individuals under legal guardianship or deprived of liberty
- Certain heart conditions including prolonged QT interval, abnormal ECG, reduced heart function, or recent severe cardiac events
- Active autoimmune disease that could worsen with immunostimulatory agents
- History of significant bleeding disorders
- Prior organ transplantation requiring immunosuppression
- Uncontrolled infections or illnesses that may affect study participation
- Active infections including tuberculosis, hepatitis B or C, or HIV
- Recent live attenuated vaccine use within 30 days before treatment
- History of deep vein thrombosis within 6 months
- Contraindications to biopsy or doxorubicin administration
- Use of oral anticoagulants based on Vitamin K antagonists
- Prior radiation treatment to the mediastinum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
2
Centre Georges François Leclerc
Dijon, France, 21079
Not Yet Recruiting
3
Centre Léon Bérard
Lyon, France, 69000
Actively Recruiting
4
Institut Paoli Calmette
Marseille, France, 13000
Not Yet Recruiting
5
Institut Curie
Paris, France, 75000
Not Yet Recruiting
6
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
7
IUCT Oncopole
Toulouse, France, 31000
Withdrawn
8
Institut Gustave Roussy
Villejuif, France, 94805
Withdrawn
Research Team
A
Antoine ITALIANO, MD, PhD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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