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Clinical Trial Summary

In summary, there is a high medical need for patients suffering from recurrent/progressive PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the treatment of these patients.


Clinical Trial Description

The objective of this study are:

PRIMARY OBJECTIVES

- To evaluate the Overall Response Rate (CR/PR) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy

- To evaluate the safety of pembrolizumab in subjects diagnosed with recurrent PCNSL

SECONDARY OBJECTIVES

- To describe Best Overall Response categories (CR, PR, SD, PD) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy

- To describe individual duration of response over time

- To assess progression-free survival in this patient population

- To assess overall survival in this patient population

EXPLORATORY OBJECTIVES

- To assess PD-L1 as a predictive marker for response to pembrolizumab ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma

NCT number NCT02779101
Study type Interventional
Source Medical University of Vienna
Contact Matthias Preusser, MD
Phone +43140400
Email matthias.preusser@meduniwien.ac.at
Status Recruiting
Phase Phase 2
Start date June 2016
Completion date June 2019

See also
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Recruiting NCT02836158 - Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL Phase 2/Phase 3
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