Spots Global Cancer Trial Database for Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

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Trial Identification

Brief Title: Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

Official Title: A Phase II, Open-Label, Single-Arm Trial Using KEYTRUDA (Pembrolizumab) as Initial Systemic Therapy in the Treatment of Advanced Mycosis Fungoides

Study ID: NCT03695471

Conditions

Mycosis Fungoides

Sezary Syndrome

Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IVA1 Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IVA2 Mycosis Fungoides and Sezary Syndrome AJCC v8

Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v8

Interventions

Pembrolizumab

Study Description

Brief Summary: This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the antitumor activity of pembrolizumab in patients with advanced mycosis fungoides (MF) as initial systemic therapy. SECONDARY OBJECTIVES: I. To evaluate safety of pembrolizumab in this patient population. II. To evaluate response rates of pembrolizumab in this patient population. III. To determine the progression free survival, duration of response, time to response and overall survival of pembrolizumab in this patient population. CORRELATIVE OBJECTIVE: I. To characterize the histologic features of the anti-tumor response in patients with advanced MF before and after treatment with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 cycles or until complete response in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, and then every 3 months for up to 1 year.