Trials / Completed

CompletedNCT02935790

Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab

A Phase 1b Study of the Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 1 (actual)

Sponsor: Celgene · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab and nivolumab in patients with unresectable Stage III/Stage IV melanoma.

Detailed description

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 ACY-241 administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab at 1 mg/kg and nivolumab at 3 mg/kg every 3 weeks for 4 doses each during a 12-week induction period, then administered with nivolumab at a flat dose of 240 mg every 2 weeks in maintenance for up to 1 year in patients with unresectable Stage III/Stage IV melanoma. 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 ACY-241.

Conditions

Malignant Melanoma

Interventions

Type	Name	Description
DRUG	ACY-241	tablet
DRUG	nivolumab	infusion
DRUG	ipilimumab	infusion

Timeline

Start date: 2016-09-30
Primary completion: 2017-04-07
Completion: 2017-04-07
First posted: 2016-10-18
Last updated: 2017-08-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02935790. Inclusion in this directory is not an endorsement.