66 Participants Needed

Pembrolizumab for Lymphoma

Recruiting at 27 trial locations
TF
Overseen ByToll Free Number
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

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot be on certain treatments like systemic steroids above a specific dose or have had recent treatments like monoclonal antibodies or radiotherapy. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug pembrolizumab for treating lymphoma?

Pembrolizumab has shown significant effectiveness in treating Hodgkin Lymphoma and has demonstrated promising responses in some subtypes of non-Hodgkin Lymphoma that share genetic features with Hodgkin Lymphoma. Additionally, it has shown promising activity in relapsed or difficult-to-treat extranodal NK/T-cell lymphoma.12345

Is pembrolizumab generally safe for humans?

Pembrolizumab (also known as Keytruda or MK-3475) is generally considered safe, but it can cause some immune-related side effects. These include rare cases of type 1 diabetes (a condition where the body can't produce insulin) and pneumonitis (inflammation of the lungs), which can be serious. Other common side effects include fatigue, cough, nausea, and skin rash.14678

How is the drug Pembrolizumab different from other treatments for lymphoma?

Pembrolizumab is unique because it works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells, unlike other treatments like Rituximab that target specific antigens on cancer cells directly.910111213

What is the purpose of this trial?

The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with specific types of lymphoma (cHL or PMBCL) that have come back or didn't respond to treatment. They should be fairly healthy, able to perform daily activities with ease or only limited help, and not pregnant or breastfeeding. Participants need measurable disease, may have had certain prior treatments but not others like CAR-T therapy, and must not have serious heart issues or active infections.

Inclusion Criteria

- Is not a woman of child bearing potential (WOCBP). OR
My cancer can be measured on scans and has a large enough lesion that hasn't been treated with radiation.
I am using effective birth control or have been abstinent, and will continue for 120 days after the study ends.
See 12 more

Exclusion Criteria

You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
I have received CAR-T cell therapy before.
I have had a serious heart condition or stroke in the last 6 months.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab 400 mg intravenously every 6 weeks, up to 18 doses

108 weeks
18 visits (in-person, every 6 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 54 months

Treatment Details

Interventions

  • Pembrolizumab
Trial Overview The study tests Pembrolizumab given every six weeks to see how well it works against two kinds of lymphoma. The main goal is to check the percentage of patients whose cancer shrinks or disappears after treatment as judged by a set standard called Lugano classification criteria.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses.

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?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

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]
Pembrolizumab, a monoclonal antibody targeting PD-1, has shown significant clinical efficacy in treating Hodgkin Lymphoma and promising early results in certain subtypes of Non-Hodgkin Lymphoma, particularly those with genetic similarities to HL.
Current data suggest that pembrolizumab has a favorable safety profile and efficacy as a single agent in treating diffuse large B cell lymphomas, with future strategies likely to focus on biomarker-driven approaches and combination therapies.
Pembrolizumab for the treatment of diffuse large B-cell lymphoma.Sheikh, S., Kuruvilla, J.[2020]
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]

References

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab for the treatment of diffuse large B-cell lymphoma. [2020]
Pembrolizumab for Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma in Korea. [2023]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. [2022]
Rituximab in the treatment of non-Hodgkin's lymphoma--a critical evaluation of randomized controlled trials. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: results of a phase II trial of rituximab. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20+ Non-Hodgkin Lymphomas. [2021]
Extended Rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. [2022]
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