NCT03695471

Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• 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-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.

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

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2020-02-04
• Primary completion: 2023-06-21
• Completion: 2024-10-08
• First posted: 2018-10-04
• Last updated: 2025-08-29
• Results posted: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study