Metastatic stage III e IV M1a melanoma MedDRA version: 6.1 Level: PT Classification code 10042551
Conditions
Interventions
Trade Name: VIVOTIF*3CPS 200MG 2000MILIONI
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Typhoid, oral, live attenuated
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: stage III and IV M1A melanoma patients with at least three non resectable superficial metastatic lesions, aged at least 18 years with HLA-A 0201 allele; adequate bone-marrow reserve, renal and hepatic functions and cardiac function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Principal exclusion criteria presence of visceral metastases; relevant medical history including primary or secondary immune deficiencies or known significant autoimmune disease, serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to 5 years, coagulation disorders, other malignancies within 5 years and need for immunosuppressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety according to the common toxicity criteria CTC version 3.0. The rate of objective clinical response CR, PR and MR .;Secondary Objective: Monitoring of immune-response Progression-free survival;Primary end point(s): The rate of grade 3 / 4 toxicity. Objective clinical response CR or PR . | — |
Countries
Italy
Outcome results
None listed