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 — DRUGPembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.
- Guadecitabine — DRUGGuadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.
- Mocetinostat — DRUGMocetinostat 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 mocetinostatPembrolizumab given IV; guadecitabine given SQ, mocetinostat given PO.
Primary Outcome Measure
number of patients with adverse events [ Time Frame: 1 year ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| John Hopkins Medical Center | Baltimore | Maryland | 21287 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | - |
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