unresectable metastatic (stage IV)non-uveal melanoma MedDRA version: 6.1 Level: PT Classification code 10025654
Conditions
Sponsors
PHILOGEN S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed unresectable metastatic (stage IV) non-uveal melanoma Age > 18 years Measurable disease defined as at least one lesion that can be accurately and serially measured as per modified RECIST criteria. Prior therapy for metastatic melanoma: oPhase I dose escalation: prior therapy allowed, including prior chemotherapy; previous treatment with DTIC: patients should be treated > 6 months prior to study entry oPhase II : no prior therapy except radiation. However, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary ocular melanoma Evidence of brain metastasis Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated Grade II, New York Heart Association (NYHA) criteria). Uncontrolled hypertension. Ischemic peripheral vascular disease (Grade Iib-IV). Severe diabetic retinopathy. Active autoimmune disease History of organ allograft or stem cell transplantation. Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment. Known history of allergy to IL2, dacarbazine, or other intravenously administered human proteins/peptides/antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of DTIC in patients with metastatic melanoma, the preliminary tolerability profile of the combination. 2. To evaluate objective response rate (ORR) at the end of induction;Secondary Objective: 1. To investigate the: Pharmacokinetics of L19IL2 and dacarbazine Induction of human anti-fusion protein antibodies (HAFA) Antitumor activity of L19IL2 with dacarbazine in patients with metastatic melanoma. 2. To estimate progression -free survival (PFS) To estimate overall survival (OS) To assess safety and tolerability;Primary end point(s): 1. determination of the recommended dose of L19IL2 when administered in combination with a fixed dose of dacarbazine. the preliminary tolerability profile . 2. determination of objective response rate (ORR) at the end of induction | — |
Countries
Austria, Germany, Italy
Outcome results
None listed