NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis)Phase 2NCT03728972
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
A Phase 2 study testing Pembrolizumab in people with NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis) and NK/T-Cell Lymphoma of Nasopharynx (Diagnosis), run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial summary
The purpose of this study is to test how well pembrolizumab shrinks Early-Stage NK/T-cell Lymphoma (ENKTL) in participants who have not yet received chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis), NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)
- What is being tested?
- Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Nov 2018to Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Md Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford University
Stanford, California, 94305
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: Pilot Study of Pembrolizumab in Untreated Extranodal, NK/T Cell Lymphoma, Nasal Type
The purpose of this study is to test how well pembrolizumab shrinks Early-Stage NK/T-cell Lymphoma (ENKTL) in participants who have not yet received chemotherapy.
- Conditions
- NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis), NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)
- Being tested
- Pembrolizumab
- Keywords
- Pembrolizumab, Early stage NK/T-Cell Lymphoma, 18-393, Memorial Sloan kettering Cancer Center
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
200mg IVPB every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) | Experimental | Not described Receives: Drug: Pembrolizumab |
| Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) | Experimental | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate of Pembrolizumab in Untreated Early-Stage NK/T-cell Lymphoma, Nasal Type (ENKTL)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start9 Nov 2018
- Primary completion15 Jun 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Moskowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728972
- Sponsor's protocol ID
- 18-393
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2018
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided