Clinical Trials /

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

NCT03728972

Description:

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.

Related Conditions:
  • Nasal Type Extranodal NK/T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
  • Official Title: Pilot Study of Pembrolizumab in Untreated Extranodal, NK/T Cell Lymphoma, Nasal Type

Clinical Trial IDs

  • ORG STUDY ID: 18-393
  • NCT ID: NCT03728972

Conditions

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

Interventions

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

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)Experimental
  • Pembrolizumab
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)Experimental
  • Pembrolizumab

Eligibility 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 within 30 days prior to the first dose of study drug.
             Examples of live vaccines include, but are not limited to, the following: measles,
             mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
             Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
             are generally killed virus vaccines and are allowed; however, intranasal influenza
             vaccines (eg, FluMist) are live attenuated vaccines and are not 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate of pembrolizumab in untreated Early-Stage NK/T-cell Lymphoma, Nasal type (ENKTL)
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

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

Last Updated

October 7, 2019