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

Who is this study for? Patients with Sarcoma
What treatments are being studied? Doxorubicin
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).

• Metastatic or unresectable locally advanced disease,

• No previous systemic treatment for advanced/metastatic disease,

• For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),

• Age ≥ 18 years,

• ECOG ≤ 1,

• Life expectancy \> 3 months,

• Patients must have measurable disease defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension as \> 10 mm with spiral CT scan.,

• Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,

⁃ Adequate hematological, renal, metabolic and hepatic function

⁃ Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,

⁃ Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.

⁃ No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in \> 1 year,

⁃ Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to to NCI-CTCAE, version 5.0,

⁃ Voluntarily signed and dated written informed consent prior to any study specific procedure,

⁃ Patients with a social security in compliance with the French law.

Locations
Other Locations
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Georges François Leclerc
NOT_YET_RECRUITING
Dijon
Centre Léon Bérard
RECRUITING
Lyon
Institut Paoli Calmette
NOT_YET_RECRUITING
Marseille
Institut Curie
NOT_YET_RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
IUCT Oncopole
WITHDRAWN
Toulouse
Institut Gustave Roussy
WITHDRAWN
Villejuif
Contact Information
Primary
Antoine ITALIANO, MD, PhD
a.italiano@bordeaux.unicancer.fr
+33556333333
Backup
Simone MATHOULIN-PELISSIER, MD, PhD
s.mathoulin@bordeaux.unicancer.fr
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 80
Treatments
Experimental: Experimental Arm A: treatment by bintrafusp alfa combined with doxorubicin
Soft-tissue sarcoma patients with an inflammed tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance
Other: Standard Arm B: treatment by doxorubicin
Soft-tissue sarcoma patients with an inflammed tumor will be treated with doxorubicin for 6 cycles
Experimental: Experimental Arm C: treatment by bintrafusp alfa combined with doxorubicin
Soft-tissue sarcoma patients with a cold tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance
Other: Standard Arm D: treatment by doxorubicin
Soft-tissue sarcoma patients with a cold tumor will be treated with doxorubicin for 6 cycles
Related Therapeutic Areas
Sponsors
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Leads: Institut Bergonié

This content was sourced from clinicaltrials.gov

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