Pembrolizumab + Radiation Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byChelsea C. Pinnix

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

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 and external beam radiation therapy work in treating patients with non-Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 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. Giving pembrolizumab and external beam radiation therapy may work better in treating patients with non-Hodgkin lymphoma than pembrolizumab alone.

Eligibility Criteria

This trial is for patients with relapsed or refractory non-Hodgkin lymphoma who can undergo radiation therapy, have measurable disease, and are in good health otherwise. They must not be pregnant, agree to use contraception, and cannot have had certain recent treatments or active infections like TB or hepatitis.

Inclusion Criteria

I am willing to use birth control during the study.

My lymphoma is confirmed to be an aggressive type.

Have measurable disease (>= 1.5 cm in the longest diameter for nodal or extranodal disease)

+6 more

Exclusion Criteria

Has known psychiatric or substance abuse disorders

I have had a stem cell transplant from a donor.

I have been diagnosed with a specific autoimmune disease.

+17 more

Participant Groups

The study is testing the combination of pembrolizumab (an immunotherapy drug) with external beam radiation therapy to see if it's more effective than pembrolizumab alone for treating non-Hodgkin lymphoma that has returned after treatment or hasn't responded to previous therapies.

1Treatment groups

Experimental Treatment

Group I: Treatment (EBRT, pembrolizumab)Experimental Treatment2 Interventions

Beginning on day 1, patients undergo fractionated EBRT daily for 5 consecutive days a week for up to 12 or 22 treatments. Patients also receive pembrolizumab IV over 1 hour on day 2. Treatment with pembrolizumab repeats every 21 days for up to 35 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: