← Back to Search

PD-1 Inhibitor

Pembrolizumab for T-Cell Lymphoma

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test if pembrolizumab can shrink ENKTL before chemotherapy is 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate of pembrolizumab in untreated Early-Stage NK/T-cell Lymphoma, Nasal type (ENKTL)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
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
~2010

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,870 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
576 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03728972 — Phase 2
Nasal Lymphoma Research Study Groups: Early-Stage NK/T-cell Lymphoma/ENKTL (Stage I/II), Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV)
Nasal Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03728972 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03728972 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab received official clearance by the FDA?

"Our experts at Power assigned a probability score of 2 to pembrolizumab due to the lack of efficacy data; however, there is some evidence that this medication provides safe treatment."

Answered by AI

What maladies are usually remedied by Pembrolizumab?

"Pembrolizumab is frequently utilized to treat malignant neoplasms, but it has also been found to be a viable option for treating unresectable melanoma, cases of microsatellite instability high, and diseases that have progressed after chemotherapy."

Answered by AI

How many participants are being enrolled in this medical trial?

"To complete the trial, 19 patients that meet the established criteria must be enrolled. Those eligible to participate can join from either Memorial Sloan Kettering Monmouth in Middletown, New jersey or Memorial Sloan Kettering Bergen in Montvale, California."

Answered by AI

What other trials have explored the potential of Pembrolizumab?

"Pembrolizumab has been investigated since 2010, with 251 studies reaching completion. Currently, there are 961 active trials being conducted in Middletown and other cities within New jersey."

Answered by AI

Are there any venues in North America that are actively engaging with this research?

"The 16 sites offering this medication include Memorial Sloan Kettering Monmouth in Middletown, Montvale's Memorial Sloan Kettering Bergen, and Basking Ridge's (Limited Protocol Activities) Memoral Sloan Kettering. Additionally, there are 13 other locations available across the United States of America."

Answered by AI

Does this investigation have open enrollment for participants?

"Correct. Details available on clinicaltrials.gov demonstrate that this medical study, which was initially posted on November 9th 2018, is presently recruiting patients. It requires 19 participants from 16 centres to reach its goals."

Answered by AI
~2 spots leftby Nov 2024