Overview

A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

Status:
Terminated

Trial end date:
2020-01-13

Target enrollment:

Participant gender:

Summary

This is a Phase 1b, open-label, dose-escalation cohort study. The study will consist of a dose escalation assessment of the safety and tolerability of Mocetinostat administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will enable selection of the RP2D and dose schedule of this 3-drug combination for further clinical testing. The trial will include an assessment of the pharmacodynamic activity of Mocetinostat administered in combination with ipilimumab and nivolumab.

Phase:

Phase 1

Details

Lead Sponsor:

New York University School of Medicine
NYU Langone Health

Treatments:

Antibodies, Monoclonal
Histone Deacetylase Inhibitors
Ipilimumab
Mocetinostat
Nivolumab