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Clinical Trial Summary

This phase II trial studies how well pembrolizumab works in treating participants with B-cell non-Hodgkin lymphoproliferative diseases that have not been treated. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To gain a preliminary assessment of the efficacy of pembrolizumab as monotherapy for patients with untreated indolent B-cell non-Hodgkin lymphoproliferative diseases (iBCL) based on overall response rate (ORR) measured at the end of a 6-cycle treatment period.

SECONDARY OBJECTIVES:

I. To assess the safety and toxicity profile of pembrolizumab in patients with untreated iBCL.

II. To measure the efficacy of pembrolizumab used as monotherapy for patients with untreated iBCL by assessing clinical outcomes including complete response rate (CR), time to next therapy (TNT), progression-free survival (PFS), and the duration of response (DOR).

OUTLINE:

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

After completion of study treatment, participants are followed up for 30 days and then up to 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03498612
Study type Interventional
Source University of Washington
Contact
Status Recruiting
Phase Phase 2
Start date October 9, 2018
Completion date March 14, 2022

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