An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

March 22, 2019

Primary Completion Date

December 31, 2022

Study Completion Date

July 31, 2023

Conditions
Melanoma
Interventions
DRUG

Entinostat

Oral drug 5 mg taken once weekly for up to nine 3-week (21 day) cycles. Take on an empty stomach i.e., at least 2 hours after a meal and at least 1 hour before the next meal. On days when entinostat is administered on the same day as pembrolizumab, entinostat should be taken before the pembrolizumab infusion.

DRUG

Pembrolizumab

200 mg IV starting on Day 22 (cycle 2, Day 1) given every 3 weeks for up to 8 cycles.

Trial Locations (1)

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syndax Pharmaceuticals

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT03765229 - An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma | Biotech Hunter | Biotech Hunter