E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
resected stage IIc, III or IV malignant melanoma |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025650 |
E.1.2 | Term | Malignant melanoma |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Clinical Efficacy measured by relapse free survival at 18 months |
|
E.2.2 | Secondary objectives of the trial |
Safety Overall survival NY-ESO-1 specific immunity |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of Relapse-free Survival (RFS) at 18 months.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
After 12 months of follow-up post last injection |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 35 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 35 |