Histologically-confirmed malignant melanoma of the skin with presence of injectable cutaneous and/or subcutaneous lesions either in clinical stage III or stage IV M1a. MedDRA version: 14.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms b
Conditions
Interventions
Product Name: tumor-targeting human L19TNFalpha monoclonal antibody-cytokinbe fusion protein
Product Code: L19TNFalfa
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code:
Sponsors
PHILOGEN S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed malignant melanoma of the skin in clinical stage III or stage IV M1a 2)Presence of measurable and injectable cutaneous and/or subcutaneous lesions 3)Males or females, age >/= 18 years 4)ECOG/WHO performance status 1.5 x 10^9/L 7)Hemoglobin > 9.0 g/dL 8)Platelets > 100 x 10^9/L 9)Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Uveal melanoma and mucosal melanoma 2)Evidence of visceral metastases and/or active brain metastases at screening 3)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) 9)Uncontrolled hypertension 10)Ischemic peripheral vascular disease (Grade IIb-IV) 11)Severe diabetic retinopathy 12)Active autoimmune disease 13)History of organ allograft or stem cell transplantation 14)Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment. 15)Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies. 16)Breast feeding female 17)Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery). 18)Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment. 19)Planned administration of growth factors or immunomodulatory agents within 7 days before the administration of study treatment 20)Patients in need of systemic treatment for rapidly progressive systemic disease. 21)Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. oAny conditions that in the opinion of the investigator could hamper compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of L19IL2/L19TNF-treated lesions measured as : Rate of patients with complete response (CR) of L19IL2/L19TNF-treated lesions at week 12 (day 85).;Secondary Objective: Efficacy of L19IL2/L19TNF-treated lesions: 1)Objective response rate (Complete response CR and partial response PR) and disease control rate ( stable disease SD ) of L19IL2/L19TNF-treated lesions at week 12. Duration of objective response and disease control of L19IL2/L19TNF-treated lesions Efficacy of L19IL2/L19TNF- treated/non treated lesions: 2)Rate of patients with CR, PR and SD of all metastases at week 12, 24 and 36 (objective response rate according to RECIST v 1.1) 3) Duration of objective response and disease control of all metastases 4) Median overall survival (mOS). Safety of intratumoral administration of L19IL2/L19TNF.;Primary end point(s): Rate of patients with complete response (CR) of L19IL2/L19TNF- treated lesions at week 12 (day 85);Timepoint(s) of evaluation of this end point: Week 12 (85 days from treatment start) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): oObjective response rate (Complete response CR and partial response PR) and disease control rate ( stable disease SD ) of L19IL2/L19TNF-treated lesions at week 12. Duration of objective response and disease control of L19IL2/L19TNF-treated lesions. oRate of patients with CR, PR and SD of all metastases at week 12, 24 and 36 (objective response rate according to RECIST v 1.1) oDuration of objective response and disease control of all metastases oMedian overall survival (mOS) Safety of intratumoral administration of L19IL2/L19TNF.;Timepoint(s) of evaluation of this end point: from 12 weeks until 1 year | — |
Countries
Italy
Outcome results
None listed