Recurrent Mycosis Fungoides and Sezary Syndrome Clinical Trial
Official title:
A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides/Sezary Syndrome
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.
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.
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