FLASH: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma

Treatment of Dacarbazine + L19TNF vs. Dacarbazine alone (as active comparator) in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma.

Agents: Dacarbazine + L19TNF
Phase II
Status Recruiting
Sponsor Philogen S.p.A.

For further information please also consult ClinicalTrials.gov.

 

Open label, randomized, controlled phase II study preceded by a safety run-in part for advanced or metastatic soft-tissue sarcomas.

WHO is the trial for?
  • Age: 18 to 80 years
  • Diagnosed with advanced or metastatic soft-tissue sarcoma
  • At least two prior systemic therapies
  • Disease progression after prior line of therapy for advanced or metastatic disease
  • Overall health must be good: ECOG ≤ 2

Patients with the following criteria cannot enter this study:

  • Diagnosis of a bone sarcoma incl. Ewing sarcoma, or Kaposi's sarcoma and GIST
  • Prior treatment with TNF, L19TNF, or DTIC
  • Prior anti-cancer treatment or participation in a clinical trial within 3 weeks prior to study treatment start

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

 This study is conducted to investigate the efficacy and safety of L19TNF, a human antibody-cytokine fusion protein, in previously treated patients with advanced stage or metastatic soft-tissue sarcoma.

WHY patients might want to participate?

 This study is looking at a new treatment called L19TNF for advanced or metastatic soft-tissue sarcoma that has been unsuccessfully treated. By taking part, patients can help find out if this treatment is effective and safe, possibly giving them access to new options and contributing to medical knowledge.

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.

  1. Contact: Teresa Hemmerle, PhD
    Phone Number:+390577017816
    Email Address: regulatory@philogen.com
  2. Contact: Marco Taras, Biologist
    Phone Number:+39057717816
    Email Address: regulatory@philogen.com

STUDY DESIGN: What does the study look like?

 Approximately 86 patients will be enrolled in this study. Before entering, a safety-run will be performed. Eligable patients will be randomly assigned to one of two different arms, as follows:

  • Arm 1: Patients will receive dacarbacine (DTIC) on Day 1 every 3 weeks plus L19TNF on Days 1, 3 and 5 every 3 weeks.
  • Arm 2: Patients will receive DTIC on Day 1 every 3 weeks.

During the conduct of the study, detailed safety parameters will be routinely reviewed.

 

HOW do I get more information?

 ClinicalTrials.gov, cancer societies or soft tissues 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