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PD-1 Inhibitor
Pembrolizumab for T-Cell Lymphoma
Phase 2
Waitlist Available
Led By Alison Moskowitz, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of ≤ 1 on the ECOG Performance Scale
18 years of age on day of signing informed consent
Must not have
History of (non-infectious) pneumonitis that required steroids or current pneumonitis
Known history of Human Immunodeficiency Virus (HIV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing pembrolizumab, a medication that boosts the immune system to fight cancer, in patients with Early-Stage NK/T-cell Lymphoma who haven't had chemotherapy yet. The goal is to see if pembrolizumab can shrink the cancer before any other treatments are given.
Who is the study for?
Adults with early-stage NK/T-cell lymphoma, nasal type, who haven't had chemotherapy can join this trial. They must be generally healthy with good organ function and performance status. Women of childbearing age need a negative pregnancy test and agree to use contraception; men also have to agree to effective birth control or abstinence.
What is being tested?
The study is testing pembrolizumab's effectiveness in shrinking early-stage NK/T-cell lymphoma before any chemotherapy is given. Participants will receive pembrolizumab and their response to the treatment will be monitored.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid), infusion reactions, fatigue, liver issues, lung problems like pneumonitis, and could worsen existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my self-care but cannot do heavy physical work.
Select...
I am at least 18 years old.
Select...
I have been diagnosed with extranodal NK/T-cell lymphoma, nasal type.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have been diagnosed with HIV.
Select...
I have received a transplant from another person.
Select...
I do not have active Hepatitis B or C.
Select...
My cancer has spread to my brain or its coverings.
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I have been treated for extranodal NK/T cell lymphoma before.
Select...
I am currently on medication for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)Experimental Treatment1 Intervention
Group II: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,537 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
577 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or have it now.I can carry out all my self-care but cannot do heavy physical work.I have been diagnosed with HIV.I am not pregnant, will use birth control, and won't have unprotected sex during the study.My kidney, liver, heart, and lung functions meet the required levels.I haven't had active treatment for another cancer, except skin cancer or in situ carcinoma, in the last 2 years.I don't have any health issues that could affect the study's results.I am at least 18 years old.I have received a transplant from another person.I do not have active Hepatitis B or C.I have not received a live vaccine in the last 30 days.I have been diagnosed with extranodal NK/T-cell lymphoma, nasal type.My cancer has spread to my brain or its coverings.I have been treated for extranodal NK/T cell lymphoma before.I am currently on medication for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II)
- Group 2: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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