Metastatic Melanoma Clinical Trial
Official 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
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.
Dose limiting toxicity will be assessed during the dose-escalation part of Phase IIa from
day 1 through day 21 of the first cycle.
Response will be measured using RECIST criteria every 6 weeks (after every 2 cycles of
treatment). Patients with stable or responding disease at each assessment may receive
additional treatment for a maximum of 6 cycles of induction. Patients with stable or
responding disease after induction may receive L19IL2 (without dacarbazine) every 2 weeks as
maintenance therapy.
Tumor expression of ED-B FN and tumor uptake of L19IL2 and of Dacarbazine will be assessed
via immunohistochemistry and/or other methods deemed appropriate on tumor tissue biopsies.
Tumor biopsy will be performed on superficial accessible cutaneous and/or subcutaneous
lesions only. Tumor biopsy will be considered optional and will not preclude patient entry
on to study should the patient refuse.
Pharmacokinetics of L19IL2, Dacarbazine and AIC will be assessed from serial blood samples
using standard methods.
Overall response rate, PFS, survival rate at 6 and 12 months, and overall survival time for
all patients and separately for the patients in the Phase IIb part will be assessed using
standard methods.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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