NCT03210662

Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase II Study of Pembrolizumab and Fractionated External Beam Radiotherapy in Patients With Relapsed and Refractory Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) of pembrolizumab with concurrent fractionated external beam radiotherapy (EBRT) among patients with relapsed and refractory non-Hodgkin lymphoma (NHL). SECONDARY OBJECTIVES: I. To determine the safety of pembrolizumab with fractionated EBRT in patients with relapsed and refractory NHL. II. To determine the overall response rate and complete response rate (CRR) of irradiated and non-irradiated lesions to treatment with concurrent pembrolizumab and fractionated EBRT in patients with relapsed and refractory NHL. III. To determine the progression free survival (PFS) of pembrolizumab in combination with fractionated EBRT. IV. To determine the overall survival (OS) of pembrolizumab in combination with fractionated EBRT. V. To determine the duration of response of irradiated and non-irradiated lesions after concurrent pembrolizumab and fractionated EBRT. EXPLORATORY OBJECTIVES: I. To identify tumor and peripheral blood markers predictive of response to concurrent pembrolizumab and low to moderate dose EBRT in the setting of relapsed and refractory NHL. II. To determine if a course of hypo-fractionated EBRT can improve response after progressive disease among patients treated with fractionated EBRT and pembrolizumab. OUTLINE: 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 intravenously (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. After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year and then every 6 months thereafter.

Conditions

• Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Recurrent Aggressive Non-Hodgkin Lymphoma
• Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent T-Cell Non-Hodgkin Lymphoma
• Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
• Refractory Aggressive Non-Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Refractory T-Cell Non-Hodgkin Lymphoma
• Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
• Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo EBRT
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-02-01
• Primary completion: 2025-10-28
• Completion: 2025-10-31
• First posted: 2017-07-07
• Last updated: 2026-01-13
• Results posted: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study