Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03220477|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Pembrolizumab Drug: Guadecitabine Drug: Mocetinostat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, open-label, multi-center, therapeutic study. All patients will be assigned to receive all three study therapies. The phase 1 portion of the study will proceed as a 3+3 dose-escalation with escalating doses of guadecitabine and mocetinostat, along with fixed dose of pembrolizumab.|
|Masking:||None (Open Label)|
|Official Title:||Phase I/Ib Study of Combined Pembrolizumab Plus Guadecitabine and Mocetinostat for Patients With Advanced NSCLC (DOSE SELECTION)|
|Actual Study Start Date :||August 4, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: pembrolizumab plus guadecitabine and mocetinostat
Pembrolizumab given IV; guadecitabine given SQ, mocetinostat given PO.
Pembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.
Guadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.
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.
- number of patients with adverse events [ Time Frame: 1 year ]events occurring on or after treatment on the first day of any study therapy will be summarized by dose cohort, toxicity term, CTCAE v4.0 grade
- response rate (Phase Ib) [ Time Frame: within 6 months of treatment ]Tumor response will be assessed using RECIST 1.1. All responses must be confirmed on subsequent scan to be considered a true response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220477
|Contact: Matthew Hellmann, MDfirstname.lastname@example.org|
|Contact: Charles Rudin, MD, PhD||646-888-4527|
|United States, Maryland|
|John Hopkins Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Jarushka Naidoo, M.B.B.Ch. 410-955-8866 Jhcccro@jhmi.edu|
|Principal Investigator: Jarushka Naidoo, M.B.B.Ch.|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Matthew Hellmann, MD 646-888-4863|
|Contact: Charles Rudin, MD, PhD 646-888-4527|
|Principal Investigator: Matthew Hellmann, MD|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: Hossein Borghaei, MS, DO 888-369-2427|
|Principal Investigator:||Matthew Hellmann, MD||Memorial Sloan Kettering Cancer Center|