resected stage IIc, III or IV malignant melanoma MedDRA version: 8.1 Level: LLT Classification code 10025650 Term: Malignant melanoma
Conditions
Interventions
Product Name: NY-ESO-1 ISCOMATRIX
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo:
Sponsors
Ludwig Institute for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven malignant melanoma. Tumor expression of NY-ESO-1 antigen by immunohistochemistry. See Appendix 1. Fully resected AJCC stage IIc, III or IV melanoma within six months of surgery for melanoma. Full recovery from surgery. A minimum of 2 weeks should have elapsed since most recent surgery. No prior immunotherapy or systemic adjuvant therapy for melanoma following most recent relapse and/or resection of melanoma. Previous adjuvant therapy for a melanoma will be accepted providing patients have relapsed and been resected after this. Age = 18 years. Able to give written informed consent. Hematology and biochemistry laboratory results within the reasonable limits normally expected for the patient population. 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: Clinically serious or significant illnesses that in the opinion of the investigator would compromise the safety of the patient or the interpretation of the study endpoints Resected cerebral metastases. Ocular melanoma Other known malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ. Use of immunosuppressive drugs. Anticoagulation Known HIV positivity Chemotherapy or radiation therapy within the preceding four weeks (6 weeks for nitrosourea drugs). Lack of availability for immunological and clinical follow-up assessments. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing. Previous isolated limb perfusion (ILP). Pregnancy or breastfeeding. Refusal or inability to use effective means of contraception for women of childbearing potential. Mental impairment that may compromise the ability to give informed consent and to comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical Efficacy measured by relapse free survival at 18 months; Secondary Objective: Safety Overall survival NY-ESO-1 specific immunity ; Primary end point(s): Rate of Relapse-free Survival (RFS) at 18 months. | — |
Countries
United Kingdom
Outcome results
None listed