This trial is terminated!
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Your journey
1What's a trial
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3Review
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More info
You can access this
clinical trial
if you have
Metastatic Melanoma
and you are
over 18
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma. The study is divided in two parts: a phase IIa part, designed to establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as well as to determine the preliminary tolerability profile; the second phase IIb part evaluates the objective response rate (ORR) including a randomized study with a fixed dose of Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.

Provided treatments

  • Drug: Arm 1: L19IL2 + Dacarbazine
  • Drug: Arm 3: Dacarbazine
  • Drug: ARM 2: L19IL2 + Dacarbazine

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01055522. The sponsor of the trial is Philogen S.p.A. and it is looking for 102 volunteers for the current phase.
Official trial title:
Dose Definition and Activity Evaluation Study of the Tumor-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Combination With Dacarbazine in Patients With Metastatic Melanoma