A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma (FIBROSARC)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    102
  • sponsor
    Philogen S.p.A.
Updated on 21 April 2022
measurable disease
doxorubicin
ewing's sarcoma
angiosarcoma
desmoplastic
fibrosarcoma
primitive neuroectodermal tumor
soft tissue sarcoma
liposarcoma
synovial sarcoma
leiomyosarcoma
metastatic soft tissue sarcoma
alveolar soft part sarcoma
epithelioid sarcoma
mpnst
malignant peripheral nerve sheath tumor

Summary

The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma patients.

In the study, 102 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).

The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).

Description

Phase III, open label, randomized, controlled study in subjects with advanced or metastatic soft tissue sarcoma. In the study, 102 patients will be enrolled and parallel assigned in a 1:1 fashion to one of two different arms, as follows:

  • ARM 1: Patients will receive 75 mg/m2 doxorubicin once every 3 weeks (reference treatment).
  • ARM 2: Patients will receive 13 µg/kg L19TNF on days 1, 3 and 5 every 3 weeks in combination with 60 mg/m2 doxorubicin (once every 3 weeks).

Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter. Median PFS, PFS rates at 3, 6, 9, 12 and 18 months, mOS, OS rate at 12 and 18 months and ORR will be calculated.

Safety assessment will be performed on an ongoing basis during study participation, including standard laboratory assessments. The incidence of AEs will be summarized by severity in all patients with at least one study drug intake.

Details
Condition Soft Tissue Sarcoma
Treatment doxorubicin, Onfekafusp alfa
Clinical Study IdentifierNCT04650984
SponsorPhilogen S.p.A.
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18-75 years
Patients must have histological evidence of advanced unresectable and/or metastatic high-grade soft tissue sarcoma (grade 2 - 3 according to the FNLCC grading system) not amenable to curative treatment with surgery or radiotherapy. The following tumor types are included
Malignant fibrous histiocytoma
Myxoid and round cell liposarcoma, pleomorphic liposarcoma or dedifferentiated
Liposarcoma
Pleomorphic rhabdomyosarcoma
Myxofibrosarcoma intermediate and high-grade
Fibrosarcoma
Leiomyosarcoma
Angiosarcoma
Alveolar rhabdomyosarcoma
Unclassified sarcoma NOS
The following tumor types will not be included
GIST
Mixed mesodermal tumor
Chondrosarcoma
Synovial sarcoma
Malignant peripheral nerve sheath tumor
Epithelioid sarcoma
Embryonal rhabdomyosarcoma
Malignant mesothelioma
Neuroblastoma
Osteosarcoma
Ewing's sarcoma / primitive neuroectodermal tumor
Desmoplastic small round cell tumor
Alveolar soft part sarcoma 3. Patients must have at least one unidimensionally measurable lesion by computed
tomography as defined by RECIST criteria 1.1. This lesion should not have been
irradiated during previous treatments
\. Life expectancy of at least 3 months. 5. Eastern Cooperative Oncology
Group (ECOG) performance status of ≤ 2. 6. Documented negative test for HIV-
HBV-HCV. For HBV serology: the determination of
HBsAg, anti-HBsAg-Ab and anti-HBCAg-Ab is required. In patients with serology
documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of
vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV
HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody
but no detection of HCV-RNA indicating no current infection are eligible
\. Negative serum pregnancy test for females of childbearing potential
within 14 days of
starting treatment
\. Informed consent signed and dated to participate in the study. 9
Willingness and ability to comply with the scheduled visits, treatment plan
laboratory tests and other study procedures

Exclusion Criteria

Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma
Previous treatment with anthracycline-containing chemotherapy
Radiotherapy within 4 weeks prior to therapy
Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and haemoglobin (Hb) < 9.0 g/dl
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
Clinically significant cardiac arrhythmias or requiring permanent medication
Uncontrolled hypertension, despite optimal therapy
Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification)
Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy
Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment
Pregnancy or breast-feeding
Requirement of chronic administration of corticosteroids or other immunosuppressant drugs. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion
Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
Known active or latent tuberculosis (TB)
Concurrent malignancies other than Soft Tissue Sarcoma, unless the patient has been disease-free for at least 2 years
Known history of allergy to TNFα, anthracyclines or other intravenously administered human proteins/peptides/antibodies
Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment
Serious, non-healing wound, ulcer or bone fracture
Chronically impaired renal function or creatinine ≥ 2.0 x ULN
Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 2.5 x ULN
Allergy to study medication or excipients in study medication
Concurrent therapy with anticoagulants
Concurrent use of other anti-cancer treatments or agents other than study medication
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