Trial Outcomes & Findings for Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type (NCT NCT03728972)
NCT ID: NCT03728972
Last Updated: 2025-10-23
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-10-23
Participant Flow
Participant milestones
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
Pembrolizumab: 200mg IVPB every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
4
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
Pembrolizumab: 200mg IVPB every 3 weeks
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Disease progression
|
4
|
3
|
Baseline Characteristics
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
Baseline characteristics by cohort
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
n=15 Participants
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
n=4 Participants
Pembrolizumab: 200mg IVPB every 3 weeks
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
43.5 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
n=15 Participants
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
n=4 Participants
Pembrolizumab: 200mg IVPB every 3 weeks
|
|---|---|---|
|
Complete Response Rate of Pembrolizumab in Untreated Early-Stage NK/T-cell Lymphoma, Nasal Type (ENKTL)
|
47 percentage of pts with complete response
Interval 21.0 to 73.0
|
25 percentage of pts with complete response
Interval 1.0 to 81.0
|
Adverse Events
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 4 deaths
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
n=15 participants at risk
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
n=4 participants at risk
Pembrolizumab: 200mg IVPB every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
Other adverse events
| Measure |
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
n=15 participants at risk
Pembrolizumab: 200mg IVPB every 3 weeks
|
Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
n=4 participants at risk
Pembrolizumab: 200mg IVPB every 3 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Up to 2 years
|
50.0%
2/4 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
26.7%
4/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Gastrointestinal disorders
Epigastric Pain
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Fatigue
|
40.0%
6/15 • Up to 2 years
|
50.0%
2/4 • Up to 2 years
|
|
General disorders
Fever
|
6.7%
1/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Infections and infestations
Herpetic Lesion - Lip
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Endocrine disorders
Hypophysitis
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Itchy Lip Rash
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Itchy Skin
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Lipase increased
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Localized edema
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Mild Cold
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
3/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose Dryness
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Pain
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
papulopustular rash extremities and torso
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Serum amylase increased
|
13.3%
2/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Erythema
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Sores on Upper Palate
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Thyroid Stimulating Hormone Increased
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Renal and urinary disorders
Urinary pressure
|
6.7%
1/15 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Hepatobiliary disorders
LFTs elevated
|
40.0%
6/15 • Up to 2 years
|
75.0%
3/4 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
erythematous red spot on shoulder, scalp, and torso
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Infections and infestations
Folliculitis
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Mild erythematous rash on torso
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
Additional Information
Dr. Malin Hultcrantz MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3714
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place