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

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

FACILITYZIPCITYSTATE
Stanford University94305StanfordCalifornia
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Hackensack Meridian Health07601HackensackNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York
Md Anderson Cancer Center77030HoustonTexas

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