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Tinostamustine and Nivolumab in Advanced Melanoma — ENIgMA  

Malignant Melanoma Clinical Trial

Official title:
Open Label, Non-randomized, Phase IB Study to Characterize Safety, Tolerability and Recommended Dose of Tinostamustine and Nivolumab in Patients With Refractory, Locally Advanced or Metastatic MelAnoma

Clinical Trial Summary

This trial is a first-in-human drug combination with the first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule Tinostamustine (EDO-S101) and the anti-PD-1 monoclonal antibody Nivolumab in patients with refractory, locally advanced or metastatic melanoma.

Clinical Trial Description

Despite improvement of systemic treatment in patients with advanced melanoma, there is still unmet medical need in this group of patients. Tinostamustine is a medication without marketing authorization, while Nivolumab is approved for several tumor entities. The primary objective of this trial is to assesses the safety, tolerability and recommended dose of Tinostamustine in combination with Nivolumab in patients with advanced melanoma.Secondary objectives of this trial in patients with advanced solid tumors are to assess the preliminary efficacy of Tinostamustine when given in combination with Nivolumab and to characterize potential predictive biomarkers of the combination treatment of Tinostamustine and Nivolumab. The trial includeds patients with either histologically or cytologically confirmed inoperable stage III or metastatic stage IV melanoma with an indication for the regular systemic treatment with Nivolumab and a maximum of 1 prior systemic palliative line of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03903458
Study type Interventional
Source Cantonal Hospital of St. Gallen
Contact Elke Hiendlmeyer, Dr.
Phone 714941111
Email elke.hiendlmeyer@kssg.ch
Status Recruiting
Phase Phase 1
Start date March 7, 2019
Completion date March 15, 2024
View Details
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