Trial intelligence / Profile preview

Pembrolizumab for Relapsed/Refractory Mycosis Fungoides/Sezary Syndrome

NCT02243579Phase 2

Key facts

Status
Completed
Start
Oct 2014
Primary completion
Jan 2018
Countries
1
Sponsor
National Cancer Institute
Modality
Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
Conditions
mycosis fungoides (MF)Sézary syndrome (SS)
01

Overview

Phase 2, open-label, single-arm trial of pembrolizumab in mycosis fungoides (MF) and Sézary syndrome (SS), sponsored by National Cancer Institute. Primary endpoint: Objective Response Rate at 3.2 years. Started Oct 2014; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Treatment (pembrolizumab)

    Pembrolizumab IV every 3 weeks

03

Who it enrols

Patients with stage IB-IVB MF/SS who have relapsed or are refractory to at least one standard systemic therapy.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Duration of Response

  • Progression Free Survival

  • Overall Survival

  • Time to Onset of First Drug-related Toxicity

  • Incidence of Adverse Events

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