drugset
drugset / Trial / NCT03565406

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

NCT03565406 ↗

Phase 1 Terminated 11 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-04-25
Primary completion
2020-01-13
Completion
2020-01-13

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Mocetinostat Small molecule 40 mg Oral
Subject Mocetinostat Small molecule 50 mg Oral
Subject Mocetinostat Small molecule 70 mg Oral
Subject Mocetinostat Small molecule 90 mg Oral
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous

Indications

melanoma