Intratumoral Application of L19IL2 in Patients With Malignant Melanoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intratumoral Application of L19IL2 in Patients With Stage III/IV Melanoma.|
- Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 . [ Time Frame: week 12 ]
- Safety of intratumoral administration of L19IL2 [ Time Frame: 1-29 days ]
- Rate of patients with complete response (CR), partial response (PR) and stable disease (SD) of L19IL2 treated Index/Non-Index lesions at week 12. [ Time Frame: week 12 ]
- Duration of objective response and disease control of L19IL2 treated Index/Non-Index lesions [ Time Frame: week 6-46 ]
- Overall survival (OS) [ Time Frame: 1 year ]
- Rate of patients with complete response (CR), partial response (PR) and stable disease (SD)of all metastases [ Time Frame: week 12 ]
- Objective response rate of all metastases [ Time Frame: week 24, week 36 ]
- Disease control rate of all metastases [ Time Frame: week 24, week 36 ]
|Study Start Date:||April 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Drug: Intratumoral injections of L19IL2
Patients will be treated with intratumoral injections of L19IL2 1-3 x weekly. The maximum cumulative dose per week is 20 MioIU. Treatment duration is up to 20 weeks.
Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2. L19IL2 binds with high affinity to the EDB domain of Fibronectin, a marker of angiogenesis which is strongly upregulated in malignant melanoma lesions. This binding leads to an increased residence time of the protein at the site of disease. The biologic effect of the IL2 moiety is identical to the one of free IL-2.
The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from histopathologically-proven malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV M1a without visceral metastases. The duration of treatment could be up to 20 weeks. After the end of study visit follow-up is performed every 6 weeks until 12 months from enrollment of each patient.
Tumor assessment will be performed within 2 weeks before start of treatment and at week 12 using immune-related response criteria and RECIST 1.1. To assure that patients do not develop visceral metastases under treatment, an additional tumor assessment will be performed already at week 6 after start of therapy. Assessments at week 24 and 36 will be performed according to RECIST vs. 1.1 criteria only.
Treatment emergent adverse events will be summarized by Common Toxicity Criteria (version 4.02, CTCAE) and worst grade for all treated patients. Laboratory values and change in vital signs will be summarized.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253096
|Medizinischen Hochschule Hannover|
|Principal Investigator:||Claus Garbe, Prof. M.D.||University Hospital Tuebingen (Germany)|