Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer.

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03220477
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.
  • Guadecitabine — DRUG
    Guadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.
  • Mocetinostat — DRUG
    Mocetinostat will be administered orally with escalating doses on days 8, 10, 13, 15, 17 and 20 of each cycle with escalating doses by cohort.

Study Details

The purpose of this study is to test the safety of a combination of three drugs, pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all patients will receive the same dose. Guadecitabine and mocetinostat will be given at different doses to find out what effects, if any, they have on treating your cancer and side effects.

Key Dates

First listed
Jul 18, 2017
Start date
Aug 4, 2017
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pembrolizumab plus guadecitabine and mocetinostat
    Pembrolizumab given IV; guadecitabine given SQ, mocetinostat given PO.

Primary Outcome Measure

number of patients with adverse events [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
John Hopkins Medical CenterBaltimoreMaryland21287-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2497-

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