Study on Combination Therapy with Entinostat and Pembrolizumab for Relapsed and Hard-to-Treat Lymphomas
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT03179930
This clinical trial is exploring whether a combination of two drugs, Pembrolizumab and Entinostat, can effectively treat lymphomas that have returned or are difficult to treat. The study aims to see if this combination can shrink the lymphoma and if it is more effective than using either drug alone.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to test the effects, both good and bad, of using Pembrolizumab and Entinostat together to treat lymphoma. Researchers hope this combination can shrink the lymphoma and be more effective than using each drug separately. However, it may also cause side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of classical Hodgkin lymphoma.
- Have received at least two previous treatments and are not eligible for or have declined a stem cell transplant.
- May have previously used similar drugs if they were beneficial.
- Have at least one measurable tumor site.
- Be in good overall health with a performance status of 0 or 1.
- Have adequate blood and organ function based on specific medical tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
- Men must agree to use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Have another type of cancer, unless treated and inactive for at least 2 years.
- Have HIV, active Hepatitis B or C, or active tuberculosis.
- Are participating in another clinical trial or have used an investigational drug recently.
- Have lymphoma in the central nervous system.
- Have uncontrolled infections or serious medical conditions.
- Have a history of lung disease requiring steroids or heart problems within the last 6 months.
- Have uncontrolled heart failure, high blood pressure, or diabetes.
- Have active autoimmune diseases, except for certain stable conditions.
- Are pregnant or breastfeeding.
- Have received a live vaccine recently.
- Have had recent chemotherapy or radiation therapy and not fully recovered.
- Have allergies to components of the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University (Data Collection Only) | 60208 | Evanston | Illinois |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Roswell Park Cancer Institute (Data Collection Only) | 14263-0001 | Buffalo | New York |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
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