Details

The “phase II trial of Ipilimumab in patients with advanced melanoma and spontaneous preexisting immune response to NY-ESO-1” (CTLA-4 NY ESO 1) evaluates as primary objective the disease control rate according to immune-related response criteria after treatment with Ipilimumab. This monoclonal antibody targets the CTLA-4 receptor which downregulates the immune system. Thereby the immune response of the cytotoxic T lymphocytes is facilitated. Secondary objectives include the disease control rate according to RECIST criteria, the median progression-free-survival and the overall survival rate at 12 months. Clinical efficacy is addressed additionally during explorative analyses.  

The CTLA-4 Trial was imitated by Prof. Dr. Dirk Jäger the principal investigator. Bristol-Meyer-Squibbs supported the trial financially and provided the antibodies. The clinical phase was performed at the department of Medical Oncology at the National Center for Tumor Diseases by Prof. Dr. Dirk Jäger, Dr. Martin Haag and their colleagues.  

Starting from April 2011, 25 patients with histologically confirmed metastatic melanoma and spontaneous immune response to NY-ESO-1 have been enrolled. During an induction phase of 10 weeks, the patients have been treated with Ipilimumab every 3 weeks. Patients without immune related progressive disease continued with a maintenance therapy, consisting of Ipilimumab administration every 12 weeks starting at week 24 up to week 48 or until disease progression, discontinuation or termination of the trial. The NY-ESO-1 antigen specific cellular and humoral immune responses have been assessed at week 1, 4, 10, 24, and 48, alongside a clinically examination. A radiological and clinical disease assessment has been performed in week 12. In total every patient was followed up to 14 months. The last patient terminated his follow-up period in May 2016.

The CTLA-4 Trial is supported by project management, data management and biostatistics of the NCT Trial Centre. Currently the data management of the NCT Trial Center finalizes the last plausibility checks on trial data and the statistical analysis is already in preparation. Final results are to be expected beginning 2017.

CTIS: CTLA-4 NY-ESO-1
EudraCT: 2009-016631-35
ClinicalTrials.gov: NCT01216696