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NCT number NCT03035331
Study type Interventional
Source Mayo Clinic
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Status Recruiting
Phase Phase 1/Phase 2
Start date March 27, 2017
Completion date February 15, 2021

Clinical Trial Summary

This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the optimal dose schedule, safety and tolerability as measured by the incidence of significant toxicity of combination therapy with anti-PD-1 monoclonal antibody, cryoablation, and intra-tumor injection of autologous dendritic cell into the cryoablated tumor. (Phase I) II. Test the efficacy (overall response rate) of combination therapy with anti-PD-1 monoclonal antibody, cryoablation, and intra-tumor injection of autologous dendritic cell vaccine. (Phase II)

SECONDARY OBJECTIVES:

I. Evaluate the feasibility of this combination immunotherapy. (Phase I) II. Evaluate patient quality of life. (Phase I) III. Evaluate the partial response (PR) and complete response (CR) rate of this combination immunotherapy. (Phase II) IV. Evaluate the progression free survival, treatment free survival, duration of response, disease-free rate at 2 years, and overall survival of this combination immunotherapy. (Phase II) V. Evaluate the safety of this combination immunotherapy. (Phase II)

TERTIARY OBJECTIVES:

I. Assess the effect of combination immunotherapy on patients' immune status and anti-tumor immune response.

II. Assess the potential association between PD-1/PD-L1/PD-L2 expression in tumor and blood with clinical efficacy.

III. Assess the potential association between tumor antigen mutations and antigen-specific immune response with clinical efficacy.

IV. Evaluate patient quality of life.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive pembrolizumab intravenously (IV) on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients also receive dendritic cell therapy intratumorally (IT) on days 2, 8, and 15 of courses 2 and 3, and day 2 of courses 4 and 5. Patients undergo cryosurgery on day 2 of course 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of courses 2-5. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months during the second year post-treatment, and then every 6 months for up to 2 years.


Study Design


Related Conditions & MeSH terms


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