Study on Pembrolizumab for Patients with Early-Stage NK/T-cell Lymphoma, Nasal Type
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT03728972
This clinical trial is testing how well the drug pembrolizumab can shrink tumors in patients with early-stage NK/T-cell Lymphoma, nasal type, who have not yet received chemotherapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to see if pembrolizumab can effectively reduce the size of tumors in patients with early-stage NK/T-cell Lymphoma, nasal type, who have not undergone any chemotherapy treatment yet.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with extranodal NK/T-cell lymphoma, nasal type.
- At least 18 years old.
- In good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable disease as shown by PET/CT scans.
- Have good kidney function, with creatinine levels within normal limits or a creatinine clearance of at least 60 mL/min.
- Have good liver function, with bilirubin and liver enzyme levels within specified limits.
- Have a heart ejection fraction of at least 50%.
- Have adequate lung function.
- Women of childbearing potential must have a negative pregnancy test before starting the study 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 received any prior treatment for extranodal NK/T-cell lymphoma.
- Have other medical conditions that make participation in the study inappropriate.
- Have received a live vaccine within 30 days before starting the study drug.
- Have another active cancer that is progressing or has needed treatment in the past 2 years, except for certain skin cancers or carcinoma in situ.
- Have cancer that has spread to the brain or spinal cord.
- Have severe allergies to pembrolizumab or its ingredients.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have a history of lung inflammation needing steroids or current lung inflammation.
- Have an active infection needing treatment.
- Have a history of HIV.
- Have active Hepatitis B or C.
- Have any condition or treatment that might interfere with the study results or participation.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Are pregnant, breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.
- Have had a tissue or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94305 | Stanford | California |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Hackensack Meridian Health | 07601 | Hackensack | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
| Md Anderson Cancer Center | 77030 | Houston | Texas |
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