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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728972
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis) NK/T-Cell Lymphoma of Nasopharynx (Diagnosis) Drug: Pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Pembrolizumab in Untreated Extranodal, NK/T Cell Lymphoma, Nasal Type
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) Drug: Pembrolizumab
200mg IVPB every 3 weeks
Experimental: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) Drug: Pembrolizumab
200mg IVPB every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Complete response rate of pembrolizumab in untreated Early-Stage NK/T-cell Lymphoma, Nasal type (ENKTL) [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728972


Contacts
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Contact: Alison Moskowitz, MD 212-639-4839 moskowia@mskcc.org
Contact: Joachim Yahalom, MD 212-639-5999 yahalomj@mskcc.org

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Ranjana H Advani, MD    650-498-6000      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Alison Moskowitz, MD    212-639-4839      
Hackensack Meridian Health Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Tatyana Feldman, MD    551-996-3033      
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Alison Moskowitz, MD    212-639-4839      
United States, New York
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Alison Moskowitze, MD    212-639-4839      
United States, Texas
Md Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Swaminathan P Iyer, MD    713-441-9948      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Alison Moskowitz, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03728972    
Other Study ID Numbers: 18-393
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Pembrolizumab
Early stage NK/T-Cell Lymphoma
18-393
Memorial Sloan kettering Cancer Center
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Lymphoma, Non-Hodgkin
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents