Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type

NCT03728972 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: 18-393
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis); NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)

Keywords

Pembrolizumab; Early stage NK/T-Cell Lymphoma; 18-393; Memorial Sloan kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate of Pembrolizumab in Untreated Early-Stage NK/T-cell Lymphoma, Nasal Type (ENKTL)

  Up to 2 years

Study Arms (2)

Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)

EXPERIMENTAL

Drug: Pembrolizumab

Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)

EXPERIMENTAL

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

200mg IVPB every 3 weeks

Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II); Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of extranodal NK/T, nasal type cell lymphoma at the enrolling institution
• 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)
• 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)
• 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
• Serum total bilirubin ≤ 3 x ULN for subjects with liver metastases
• AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
• AST (SGOT) and ALT (SGPT) ≤ 5 x ULN for subjects with liver metastases
• CARDIAC:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (10)

Stanford University

Stanford, California, 94305, United States

Location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Disease

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Malin Hultcrantz MD, PhD
• Organization: Memorial Sloan Kettering Cancer Center

hultcram@mskcc.org

646-608-3714

Study Officials

• Alison Moskowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 2, 2018
• Study Start: November 9, 2018
• Primary Completion: June 15, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-08

Locations

US (10)