What is the mechanism of action of this treatment?

The most common treatments for Mycosis Fungoides, particularly immune checkpoint inhibitors like Pembrolizumab, work by targeting the PD-1 pathway. Pembrolizumab blocks the PD-1 receptor on T-cells, preventing it from binding to its ligand PD-L1 on cancer cells. This inhibition reactivates T-cells, allowing them to recognize and attack cancer cells more effectively. This mechanism is crucial for Mycosis Fungoides patients as it enhances the immune system's ability to combat the malignancy, potentially leading to better disease control and improved outcomes.

What side effects are associated with this type of intervention?

Common treatments for Mycosis Fungoides include topical therapies, phototherapy, systemic therapies, and immune checkpoint inhibitors like Pembrolizumab. Pembrolizumab, which targets PD-1, can cause immune-related adverse events such as skin rashes, pruritus, and vitiligo-like depigmentation. Other potential side effects include fatigue, diarrhea, and endocrinopathies. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Mycosis Fungoides, including immune checkpoint inhibitors like Pembrolizumab, which targets PD-1. Pembrolizumab is being studied for its efficacy in treating relapsed or refractory cutaneous T-cell lymphoma, including Mycosis Fungoides. Other related drugs include nivolumab, another PD-1 inhibitor, and ipilimumab, which targets CTLA-4. These therapies work by enhancing the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to Pembrolizumab for Mycosis Fungoides patients in 2024 include Nivolumab (another PD-1 inhibitor) and combination therapies involving immune checkpoint inhibitors such as Nivolumab with Ipilimumab. Additionally, novel delivery methods like the Sofusa DoseConnect system for targeted lymphatic delivery of immunotherapy are being explored and may offer new treatment avenues.

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Monoclonal Antibodies

Pembrolizumab for Cutaneous T-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Sorrento Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to undergo two biopsies during the study

Not previously treated with transplant and is ineligible for transplant

Must not have

Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation

Underlying medical condition resulting in abnormally slow lymphatic flow as determined by the Investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give a cancer-fighting drug called pembrolizumab to patients with a specific type of skin cancer that hasn't responded to other treatments. Pembrolizumab has shown effectiveness in treating different types of cancer, including melanoma. The drug will be delivered using a special device that targets the lymphatic system. The goal is to see if this method is safe and effective.

Who is the study for?

This trial is for adults with a specific skin cancer called cutaneous T-cell lymphoma that's gotten worse after treatment. They must have had at least one systemic therapy, be willing to undergo biopsies, and use reliable contraception if of childbearing potential. People with certain infections, autoimmune diseases, previous anti-PD-1 or PD-L1 treatments, organ transplants, severe allergies to study components or related dyes are excluded.

What is being tested?

The trial tests pembrolizumab delivered through Sofusa DoseConnect in patients with relapsed/refractory cutaneous T-cell lymphoma. It aims to see if this method of delivering the drug directly into the lymphatic system is feasible by examining its effects on tumor tissue.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) and skin reactions. Other possible side effects include fatigue, infusion reactions and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to have two biopsies for this study.

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I have not had a transplant and am not eligible for one.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is between stages IB and IIIB.

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I have had at least one treatment for my cutaneous T-cell lymphoma.

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My condition worsened during or after my last treatment.

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I have been diagnosed with Mycosis fungoides.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell or organ transplant in the past.

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My doctor says I have slow lymphatic flow due to a medical condition.

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My cancer has spread extensively to my organs or blood.

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I have a history of lung scarring or fibrosis.

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I have been treated with drugs targeting PD-L1 or PD-1 before.

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I need immediate treatment for myelofibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medical Devices

Secondary study objectives

Area Under the Curve (AUC) of the blood levels of pembrolizumab

Half-life (t1/2) of pembrolizumab

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Mycosis Fungoides, particularly immune checkpoint inhibitors like Pembrolizumab, work by targeting the PD-1 pathway. Pembrolizumab blocks the PD-1 receptor on T-cells, preventing it from binding to its ligand PD-L1 on cancer cells. This inhibition reactivates T-cells, allowing them to recognize and attack cancer cells more effectively. This mechanism is crucial for Mycosis Fungoides patients as it enhances the immune system's ability to combat the malignancy, potentially leading to better disease control and improved outcomes.

Updates in Therapy for Advanced Melanoma.The Systemic Management of Advanced Melanoma in 2016.The presentation, pathology, and current management strategies of cutaneous metastasis.