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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-05-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mocetinostat Induction Phase + Ipilimumab + Nivolumab

Treatment Cycle 1: Mocetinostat at a dose of 90 mg PO TIW; ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles. Treatment Cycle 2: Mocetinostat at a dose of 70 mg PO TIW ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles.

DRUG

Mocetinostat Maintenance Phase + Ipilimumab + Nivolumab

De-escalation Phase 1: Mocetinostat will be administered 50 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg De-escalation Maintenance Phase 2: Mocetinostat will be administered 40 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 0.3 mg/kg and nivolumab will be administered IV at a dose of 1 mg/kg during period

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Weber, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2020-01-13
Completion
2020-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565406 on ClinicalTrials.gov