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Monoclonal Antibodies
Pembrolizumab for Cutaneous T-Cell Lymphoma
Phase 1
Recruiting
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 belowSelect...
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:Select...
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.
Select...
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
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 moreAwards & 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
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.
Updates in Therapy for Advanced Melanoma.The Systemic Management of Advanced Melanoma in 2016.The presentation, pathology, and current management strategies of cutaneous metastasis.
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Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,954 Total Patients Enrolled
Andreas G Niethammer, MD PhDStudy DirectorSorrento Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have two biopsies for this study.I have not had a transplant and am not eligible for one.I have had a stem cell or organ transplant in the past.I agree to use birth control during and for 4 months after the study.I am fully active or restricted in physically strenuous activity but can do light work.My organs are working well.My doctor says I have slow lymphatic flow due to a medical condition.My cancer is between stages IB and IIIB.I agree to use condoms during the study and for 4 months after the last dose.I do not have an active autoimmune disease, except for vitiligo, stable thyroid disease, or Type 1 diabetes.I have had at least one treatment for my cutaneous T-cell lymphoma.My cancer has spread extensively to my organs or blood.I have a history of lung scarring or fibrosis.My condition worsened during or after my last treatment.I have been treated with drugs targeting PD-L1 or PD-1 before.I have been diagnosed with Mycosis fungoides.I am 18 years old or older.You are currently using drugs or alcohol excessively.I need immediate treatment for myelofibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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