A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT04650984
Last Updated: 2024-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
102 participants
INTERVENTIONAL
2017-11-29
2025-12-31
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Patients will receive 75 mg/m2 doxorubicin once every 3 weeks (reference treatment).
Doxorubicin
Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.
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).
Onfekafusp alfa
Patients will receive a fixed dose of L19TNF in combination with a fixed dose of doxorubicin.
Doxorubicin
Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.
Interventions
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Onfekafusp alfa
Patients will receive a fixed dose of L19TNF in combination with a fixed dose of doxorubicin.
Doxorubicin
Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have histological evidence of advanced unresectable and/or metastatic high-grade soft tissue sarcoma (grade 2 - 3 according to the FNCLCC grading system) not amenable to curative treatment with surgery or radiotherapy and for which doxorubicin treatment is considered appropriate. Participants with Osteosarcoma, Chondrosarcoma, Ewing Sarcoma/ Primitive Neuroectodermal Tumor (PNET), Kaposi's Sarcoma, Dermatofibrosarcoma protuberans, and Gastrointestinal Stromal Tumors (GIST) will be excluded
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.
4. 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.
7. Female patients: negative serum pregnancy test at screening for women of childbearing potential (WOCBP)\*. WOCBP must agree to use, from the screening to six months following the last administration of L19TNF and/or Doxorubicin, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception from the screening to four months following the last administration of L19TNF and/or Doxorubicin (e.g. condom with spermicidal gel). Double-barrier contraception is required.
8. 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
2. Previous treatment with anthracycline-containing chemotherapy.
3. Radiotherapy within 4 weeks prior to therapy.
4. Known history of allergy to TNFα, anthracyclines or other intravenously administered human proteins/peptides/antibodies.
5. Previous therapy with recombinant TNF.
6. Absolute neutrophil count (ANC) \< 1.5 x 109/L, platelets \< 100 x 109/L and haemoglobin (Hb) \< 9.0 g/dl.
7. Chronically impaired renal function or creatinine ≥ 2.0 x ULN.
8. Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 2.5 x ULN.
9. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
10. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
11. Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria).
12. Clinically significant cardiac arrhythmias or requiring permanent medication.
13. Uncontrolled hypertension, despite optimal therapy.
14. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
15. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
16. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
17. Pregnancy or breast-feeding.
18. 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.
19. 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.
20. Known active or latent tuberculosis (TB).
21. Concurrent malignancies other than Soft Tissue Sarcoma, unless the patient has been disease-free for at least 2 years.
22. Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
23. Serious, non-healing wound, ulcer or bone fracture.
24. Allergy to study medication or excipients in study medication.
25. Deep vein thrombosis, pulmonary embolism or other acute vascular events within 6 months.
26. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).
27. Concurrent use of other anti-cancer treatments or agents other than study medication.
18 Years
75 Years
ALL
No
Sponsors
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Philogen S.p.A.
INDUSTRY
Responsible Party
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Locations
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Institut Bergonié
Bordeaux, , France
Centre Georges François Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Bad Saarow
Bad Saarow, , Germany
Charité- Universitätsmedizin Berlin
Berlin, , Germany
Uniklinik Köln
Cologne, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinik Hamburg-Eppendorf
Hamburg, , Germany
Heidelberg University Hospital
Heidelberg, , Germany
Universitätsmedizin der J.-G. Universität Mainz
Mainz, , Germany
Klinik rechts der Isar
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
IRCCS Fondazione del Piemonte per l'Oncologia Istituto per la Ricerca e la Cura del Cancro di Candiolo
Candiolo, Torino, Italy
Bologna University, Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, Department of DIMES
Bologna, , Italy
AOU San Luigi Gonzaga
Orbassano, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Szpital Pomorski Im. PCK
Gdynia, , Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warszawa
Warsaw, , Poland
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Antoine Italiano
Role: primary
Alice Hervieu
Role: primary
Jean-Yves Blay
Role: primary
Agnès Ducolombier
Role: primary
Thibaud Valentin
Role: primary
Axel Le Cesne
Role: primary
Daniel Pink, Dr
Role: primary
Anne Floercken, PD Dr. med.
Role: primary
Roland Ulrich
Role: primary
Judith Strapatsas, PD Dr. med.
Role: primary
Marit Ahrens, MD
Role: primary
Jana Kaethe Striefler, PD Dr. med.
Role: primary
Gerlinde Egerer, MD
Role: primary
Marius Fried, PD Dr.
Role: primary
Judith Hecker, PD Dr. med
Role: primary
Christoph Schliemann, Prof. MD
Role: primary
Sandra Aliberti, Dr.
Role: primary
Emanuela Palmerini, MD
Role: primary
Lorenzo D'Ambrosio, Dr.
Role: primary
Michela Quirino, Dr.
Role: primary
Joanna Pikiel
Role: primary
Piotr Rutkowski, MD
Role: primary
Jeronimo Martinez Garcia, Dr.
Role: primary
Claudia Valverde Morales, Dr.
Role: primary
Lucía Castillo Portellano
Role: primary
Javier M Broto, MD
Role: primary
Rosa María Álvarez, Dr.
Role: primary
Javier Martinez Trufero, Dr.
Role: primary
Other Identifiers
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PH-L19TNFDOX2-03/16
Identifier Type: -
Identifier Source: org_study_id
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