Pembrolizumab for Non-Hodgkin's Lymphoma

Palo Alto (17 mi)

Overseen byAjay K. Gopal

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well pembrolizumab works in treating patients with B-cell non-Hodgkin lymphoproliferative diseases that have not been treated. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

This trial is for adults with untreated B-cell non-Hodgkin lymphoproliferative diseases who need treatment and have measurable disease. Participants must be in good physical condition (ECOG 0 or 1), not pregnant, willing to use birth control, and without serious health issues like active TB, HIV, certain cancers, CNS metastases, or severe autoimmune diseases.

Inclusion Criteria

My lymphoma is getting worse over time.

I have symptoms or conditions that require treatment according to NCCN guidelines.

I have a tumor larger than 1.5 cm that can be measured by CT or MRI.

My organ function is at risk due to my cancer.

I am fully active or restricted in physically strenuous activity but can do light work.

My blood cell counts are dropping due to my lymphoma.

My kidney function is within the required range for the study.

I have a tumor larger than 1.5 cm that can be measured by CT or MRI.

Exclusion Criteria

I have been diagnosed with HIV.

I need urgent treatment for my lymphoma complications.

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

I have received treatment for iBCL before.

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

I have a history of or currently have non-infectious lung inflammation.

I am currently being treated for an infection.

I have only received the flu shot, not the nasal spray vaccine.

I have an active tuberculosis infection.

I have not received a live vaccine in the last 30 days.

I have cancer that has spread to my brain or spinal cord.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Treatment Details

The study tests pembrolizumab's effectiveness on patients with specific types of lymphoma. Pembrolizumab is an immunotherapy drug that may help the immune system fight cancer by blocking a pathway tumors use to hide from it.

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as KEYTRUDA for: