NCT02243579

Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome

A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides/Sezary Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement or has not responded to at least one type of treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the response rate of MK-3475 (pembrolizumab) in subjects with relapsed/refractory mycosis fungoides/Sezary syndrome (MF/SS). SECONDARY OBJECTIVES: I. To explore the clinical activity of MK-3475 in subjects with relapsed/refractory MF and SS with respect to the following endpoints: duration of response (DOR); progression-free survival (PFS); overall survival (OS). OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving complete response \[CR\]) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.

Conditions

• Recurrent Mycosis Fungoides and Sezary Syndrome
• Refractory Mycosis Fungoides and Sezary Syndrome
• Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7
• Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2014-10-15
• Primary completion: 2018-01-04
• Completion: 2019-04-01
• First posted: 2014-09-18
• Last updated: 2019-09-20
• Results posted: 2019-02-05

Locations

8 sites across 1 country: United States