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All Drugs and Chemicals

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.

Mayo Clinic

Lymphoma, T-Cell, Peripheral

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Antibodies

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Mogamulizumab

Immunologic Factors

Patients receive mogamulizumab IV over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CR)/PR after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

Extracorporeal Photopheresis

Quality-of-Life Assessment

Questionnaire Administration

Christiane R. Querfeld

Christiane R Querfeld

This phase II trial studies the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP is a medical treatment that removes blood with a machine, isolates white blood cells and exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with mogamulizumab) and boost immune response to cancer (with ECP).

PRIMARY OBJECTIVE:

I. To assess tolerability and overall response rate (ORR) of the (ECP)/mogamulizumab regimen in CTCL patients previously untreated with mogamulizumab.

SECONDARY OBJECTIVES:

I. To estimate complete response (CR) rate, time to response, duration of response, progression free survival, and overall survival in CTCL patients treated with the ECP/mogamulizumab combination.

II. To summarize the toxicities in CTCL patients treated with the ECP/mogamulizumab combination.

EXPLORATORY OBJECTIVES:

I. To assess quality of life (QoL) parameters before, during, and after the regimen.

II. To evaluate the anti-tumor and immunomodulatory effects of mogamulizumab in the CTCL microenvironment in skin and blood samples of erythrodermic CTCL patients.

III. To evaluate the immunomodulatory effects of ECP.

OUTLINE:

Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, of cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR)/partial response (PR) after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then for up to 12 months.

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

ORR will be calculated as the proportion of evaluable patients that have confirmed complete response (CR) or partial response (PR), as defined according to global response assessment. Exact 95% confidence intervals will be calculated for these estimates.

Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.

Defined as the proportion of response-evaluable patients that have a documented CR.

Will be estimated using the product-limit method of Kaplan and Meier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides	NCT03695471	Mycosis Fungoid... Sezary Syndrome Stage IB Mycosi... Stage II Mycosi... Stage IIA Mycos... Stage IIB Mycos... Stage III Mycos... Stage IIIA Myco... Stage IIIB Myco... Stage IV Mycosi... Stage IVA1 Myco... Stage IVA2 Myco... Stage IVB Mycos...	Pembrolizumab	18 Years -	Mayo Clinic
Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma	NCT04930653	Folliculotropic... Primary Cutaneo... Sezary Syndrome Stage IB Mycosi... Stage II Mycosi... Stage IIA Mycos... Stage IIB Mycos... Transformed Myc...	Extracorporeal ... Mogamulizumab Quality-of-Life... Questionnaire A...	18 Years -	City of Hope Medical Center

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