- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728972
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
Pilot Study of Pembrolizumab in Untreated Extranodal, NK/T Cell Lymphoma, Nasal Type
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joachim Yahalom, MD
- Phone Number: 212-639-5999
- Email: yahalomj@mskcc.org
Study Contact Backup
- Name: Alison Moskowitz, MD
- Phone Number: 212-639-4839
- Email: moskowia@mskcc.org
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Ranjana H Advani, MD
- Phone Number: 650-498-6000
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack Meridian Health
-
Contact:
- Tatyana Feldman, MD
- Phone Number: 551-996-3033
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Alison Moskowitz, MD
- Phone Number: 212-639-4839
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
Contact:
- Alison Moskowitze, MD
- Phone Number: 212-639-4839
-
-
Texas
-
Houston, Texas, United States, 77030
- Not yet recruiting
- MD Anderson Cancer Center
-
Contact:
- Swaminathan P Iyer, MD
- Phone Number: 713-441-9948
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
|
200mg IVPB every 3 weeks
|
Experimental: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
|
200mg IVPB every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete response rate of pembrolizumab in untreated Early-Stage NK/T-cell Lymphoma, Nasal type (ENKTL)
Time Frame: Up to 2 years
|
Up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alison Moskowitz, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Disease
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- 18-393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis)
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Severance HospitalCompletedNK/T-cell Lymphoma of Nasal CavityKorea, Republic of
-
Hunan Cancer HospitalRecruitingChemotherapy Effect | NK/T-cell Lymphoma of Nasal Cavity | Immune Checkpoint Inhibitor | Epigenetic DisorderChina
-
Samsung Medical CenterAsan Medical Center; Yonsei University; Seoul National University; Chonnam National...CompletedExtranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypeKorea, Republic of
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedExtranodal NK/T-cell Lymphoma, Nasal TypeChina
-
Ruijin HospitalUnknownNasal Type Extranodal NK/T-Cell LymphomaChina
-
Sun Yat-sen UniversityEli Lilly and Company; Hoffmann-La RocheUnknownExtranodal NK/T-cell Lymphoma, Nasal TypeChina
-
Fudan UniversityTerminatedExtranodal NK/T-cell Lymphoma, Nasal TypeChina
-
Beijing Tongren HospitalNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal Type
-
Jiangsu HengRui Medicine Co., Ltd.UnknownExtranodal NK/T-cell Lymphoma, Nasal TypeChina
-
Ruijin HospitalCompletedNasal Type Extranodal NK/T-Cell LymphomaChina
Clinical Trials on Pembrolizumab
-
University Medical Center GroningenCompleted
-
Incyte CorporationMerck Sharp & Dohme LLCCompletedMelanomaUnited States, France, Italy, United Kingdom, Spain, Belgium, Israel, Mexico, Japan, Canada, Netherlands, Sweden, Korea, Republic of, Australia, Russian Federation, Chile, Germany, Poland, Ireland, New Zealand, Denmark, Switzerland, South Africa
-
Merck Sharp & Dohme LLCCompletedMelanomaAustralia, South Africa, Spain, Sweden
-
Acerta Pharma BVMerck Sharp & Dohme LLCCompletedMetastatic Urothelial CarcinomaUnited States
-
Sichuan UniversityGeneplus-Beijing Co. Ltd.RecruitingNon-small Cell Lung CancerChina
-
Chinese University of Hong KongCompletedAcral Lentiginous MelanomaHong Kong
-
HUYABIO International, LLC.Active, not recruitingNon Small Cell Lung CancerUnited States
-
Prof. Dr. Matthias PreusserUnknownPrimary Central Nervous System LymphomaAustria
-
Samsung Medical CenterRecruitingMetastatic Non-Small Cell Lung CarcinomaKorea, Republic of