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Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive pembrolizumab 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.

Jason C. Sluzevich, M.D.

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.

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.

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

Immunohistochemistry will be used to quantify levels of CD4 before and after treatment with pembrolizumab

Immunohistochemisty will be used for change in baseline calculations of CD4 at baseline and end of cycle 2

Immunohistochemisty will be used for change in baseline calculations of CD8 at baseline and end of cycle 2

Immunohistochemisty will be used for change in baseline calculations of PD-1/CD279 at baseline and end of cycle 2

Immunohistochemisty will be used for change in baseline calculations of PD-1 at baseline and end of cycle 2

Qualitative measures of the strength of PD-1 expression will use published standardized grading scales for categorical classification purposes.

Immunohistochemistry will be used to quantify levels of CD8 before and after treatment with pembrolizumab.

Immunohistochemistry will be used to quantify levels of PD-1/CD279 before and after treatment with pembrolizumab

Immunohistochemistry will be used to quantify levels of PD- L1 expression before and after treatment with pembrolizumab

Will be assessed by the Modified Severity Weighted Assessment Tool (mSWAT). All calculated values will use the last-observation-carried forward for any participants who withdraw, are lost to follow up, or exit the study per protocol. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients will be analyzed using Mann-Whitney U for nonparametric data and the student t-test. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Summary statistics will be calculated. Proportions of patients will be calculated and described using summary statistics. Proportions of interest are patients having CR, CR90 and PR; patients having stable subcutaneous disease; patients having progressive cutaneous disease; and patients having an overall systemic response rate.

The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate at 5 years after registration will be reported.

The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.

The distribution of survival time will be estimated using the method of Kaplan-Meier.

The distribution of survival time will be estimated using the method of Kaplan-Meier. In addition, the overall survival rate at 2 years after registration will be reported.

Spots Global Cancer Trial Database for stage ivb mycosis fungoides and sezary syndrome ajcc v8