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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) | Experimental |
| |
| Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | 200mg IVPB every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate of Pembrolizumab in Untreated Early-Stage NK/T-cell Lymphoma, Nasal Type (ENKTL) | Up to 2 years |
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Inclusion Criteria:
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)
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, 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:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Moskowitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) | Pembrolizumab: 200mg IVPB every 3 weeks |
| FG001 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) | Pembrolizumab: 200mg IVPB every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2025 |
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| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Hackensack Meridian Health | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York | 11553 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) | Pembrolizumab: 200mg IVPB every 3 weeks |
| BG001 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) | Pembrolizumab: 200mg IVPB every 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response Rate of Pembrolizumab in Untreated Early-Stage NK/T-cell Lymphoma, Nasal Type (ENKTL) | Posted | Number | 95% Confidence Interval | percentage of pts with complete response | Up to 2 years |
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|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II) | Pembrolizumab: 200mg IVPB every 3 weeks | 4 | 15 | 1 | 15 | 14 | 15 |
| EG001 | Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) | Pembrolizumab: 200mg IVPB every 3 weeks | 2 | 4 | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epigastric Pain | Gastrointestinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Herpetic Lesion - Lip | Infections and infestations | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophysitis | Endocrine disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Itchy Lip Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itchy Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lipase increased | Investigations | Systematic Assessment |
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| Localized edema | General disorders | Systematic Assessment |
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| Mild Cold | General disorders | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nose Dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| papulopustular rash extremities and torso | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Serum amylase increased | Investigations | Systematic Assessment |
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| Skin Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sores on Upper Palate | Gastrointestinal disorders | Systematic Assessment |
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| Thyroid Stimulating Hormone Increased | Investigations | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
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| Urinary pressure | Renal and urinary disorders | Systematic Assessment |
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| LFTs elevated | Hepatobiliary disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| erythematous red spot on shoulder, scalp, and torso | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Folliculitis | Infections and infestations | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Mild erythematous rash on torso | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Malin Hultcrantz MD, PhD | Memorial Sloan Kettering Cancer Center | 646-608-3714 | hultcram@mskcc.org |
| Oct 8, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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