19 Participants Needed

Pembrolizumab for T-Cell Lymphoma

Recruiting at 18 trial locations
AM
JY
Overseen ByJoachim Yahalom, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is pembrolizumab generally safe for humans?

Pembrolizumab, also known as Keytruda, has been shown to be generally safe in humans, but it can cause immune-related side effects like type 1 diabetes in rare cases (0.2%). Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related reactions can affect organs like the lungs, liver, and thyroid.12345

What makes the drug pembrolizumab unique for treating T-cell lymphoma?

Pembrolizumab is unique because it works by blocking the PD-1 pathway, which helps the immune system attack cancer cells more effectively. This approach is different from traditional chemotherapy and has shown promising results in patients with relapsed or hard-to-treat T-cell lymphomas, offering a new option where few exist.12367

What data supports the effectiveness of the drug pembrolizumab for T-cell lymphoma?

Pembrolizumab has shown promising results in treating relapsed or refractory natural killer/T-cell lymphoma, with an objective response rate of 84.5% and a complete response rate of 61.6%, indicating good short- and long-term outcomes.23678

Who Is on the Research Team?

Alison J. Moskowitz, MD - MSK Lymphoma ...

Alison Moskowitz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can carry out all my self-care but cannot do heavy physical work.
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.
See 2 more

Exclusion Criteria

I have had pneumonitis treated with steroids or have it now.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
I have been diagnosed with HIV.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab to test its effectiveness in shrinking Early-Stage NK/T-cell Lymphoma

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
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

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇪🇺
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

In a study of 59 patients with relapsed/refractory extranodal natural killer/T-cell lymphoma treated with pembrolizumab, the overall response rate was 40.7%, with 28.8% achieving a complete response, indicating its potential efficacy as a salvage therapy.
While pembrolizumab showed modest effectiveness, it was associated with some grade 3 or 4 adverse events in 20.3% of patients, with neutropenia being the most common, suggesting that while it can be beneficial, monitoring for side effects is important.
Pembrolizumab for Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma in Korea.Lee, JY., Kwon, JH., Hur, JY., et al.[2023]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Citations

Pembrolizumab for Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma in Korea. [2023]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Use of PD-1 blockade in refractory/relapsed natural killer T-cell lymphomas: a systematic review and synthesis of case reports. [2023]
Pembrolizumab for the treatment of diffuse large B-cell lymphoma. [2020]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]
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