Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Mycoses
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
Syndrome

Clinical Trial Details

NCT number	NCT03695471
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	December 20, 2018
Completion date	October 11, 2024

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02883517` - Cell-free Circulating DNA in Primary Cutaneous Lymphomas
Active, not recruiting	`NCT02953301` - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	Phase 2
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Completed	`NCT02296164` - Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Recruiting	`NCT05680558` - Photopheresis in Early-stage Mycosis Fungoides	Phase 2
Completed	`NCT00038376` - Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies	Phase 2
Completed	`NCT00168064` - Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides	Phase 2
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Recruiting	`NCT05904522` - Histopathological Changes in Mycosis Fungoides	N/A
Recruiting	`NCT05414500` - Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.