FIBROSARC: L19TNF+Doxorubicin vs Doxorubicin alone in advanced or metastatic soft tissue sarcoma

 

Agents: Onfekafusp alfa (L19TNF) + Doxorubicin vs. Doxorubicin alone
Phase III
Status Recruiting
Sponsor Philogen S.p.A.

For further information please also consult ClinicalTrials.gov.

 

A Phase III Study Comparing the Efficacy of the Combination of Doxorubicin and the  L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma.

WHO is the trial for?
  • Age range: 18-75 years
  • Patients with advanced or metastatic soft tissue sarcoma and at least one lesion
  • Overall health of the patient must be good - ECOG performance status ≤ 2
  • Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma, incl. previous treatment with anthracycline-containing chemotherapy, radiotherapy within 4 weeks prior to therapy or previous therapy with recombinant TNF.

Patients with Osteosarcoma, Chondrosarcoma, Ewing Sarcoma/ Primitive Neuroectodermal Tumor (PNET), Kaposi's Sarcoma, Dermatofibrosarcoma protuberans, and Gastrointestinal Stromal Tumors (GIST) are not eligable to participate in the study.

WHAT is the key question that this trial is attempting to answer?

 The primary objective of this study is to investigate the efficacy the combination of Doxorubicin and L19TNF to Doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma.

WHY patients might want to participate?

 Participating in this study would allow patients to access an innovative combination therapy, potentially
improving treatment outcomes for advanced or metastatic soft tissue sarcoma. Participation contributes
to medical knowledge, offering the hope of better care and a chance to receive personalized treatment.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in France, Germany, Italy, Poland and Spain.

For further information please check here.

Contact: Teresa Hemmerle, PhD
Email Address: regulatory@philogen.com
Contact: Marco Taras, Biologist
Email Address: regulatory@philogen.com

STUDY DESIGN: What does the study look like?

 This study is comparing the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft tissue sarcoma patients.

This trial has two study arms: all participating patients will be randomly divided (by a computer) in two groups. One group  receives doxorubicin alone (Arm 1), the second group will be treated with L19TNF in combination with doxorubicin (Arm 2).

HOW do I get more information?

  ClinicalTrials.gov, cancer societies or soft tissue sarcoma-focused patient advocacy groups in your country may offer
additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient
organizations that might be helpful. If there are no such organization in your country, please email us for
more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken