New hope: immune drug may replace chemo for rare nasal lymphoma
NCT ID NCT03728972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether the immune-boosting drug pembrolizumab can shrink early-stage NK/T-cell lymphoma in patients who have not yet had chemotherapy. Nineteen participants will receive the drug every three weeks. The goal is to see if this approach can control the disease without the need for standard chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could offer a chemotherapy-free option for early-stage NK/T-cell lymphoma, potentially reducing treatment side effects.
- What could go wrong
- This is a small pilot study with only 19 participants, so results may not apply to everyone. The drug may not shrink tumors effectively, and side effects like immune reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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19 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologic diagnosis of extranodal NK/T, nasal type cell lymphoma at the enrolling institution * 18 years of age on day of signing informed consent * Have a performance status of ≤ 1 on the ECOG Performance Scale * Have measurable disease by PET/CT * Demonstrate adequate organ function as defined below: RENAL: Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCL) Serum creatinine ≥ 60 mL/min for subject with creatinine levels \> 1.5 x institutional ULN ≤ 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCL) ≥ 60 mL/min for subject with creatinine levels \> 1.5 x institutional ULN HEPATIC: Serum total bilirubin ≤ 1.5 x ULN OR Serum total bilirubin ≤ 3 x ULN for subjects with liver metastases AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN OR AST (SGOT) and ALT (SGPT) ≤ 5 x ULN for subjects with liver metastases CARDIAC: Ejection fraction ≥ 50% PULMONARY: Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥ 50% \- Women of childbearing potential\* must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to receiving the first dose of study medication * \*A woman of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential must be willing to use an adequate method of contraception * Must agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 120 days after the last dose of study therapy, or agree to completely abstain from heterosexual intercourse * Male subjects of childbearing potential must agree to use an adequate method of contraception * Male subjects, even if surgically sterilized (i.e. statue post vasectomy) must agree to 1 of the following: Practice effective barrier contraception during the entire study therapy, or agree to completely abstain from heterosexual intercourse Exclusion Criteria: * Received prior treatment for extranodal NK/T cell lymphoma * Medical illness unrelated to lymphoma, which, in the opinion of the treating physician and/or institutional principal investigator, makes participation in this study inappropriate. * Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Has known active CNS metastases and/or carcinomatous meningitis. * Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Has a known history of Human Immunodeficiency Virus (HIV). * Has active Hepatitis B (defined as HBV DNA is detected) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * Has had an allogenic tissue/solid organ transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
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Md Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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Stanford University
Stanford, California, 94305, United States