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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

Study Summary

This trial will test if a new way of delivering the cancer drug pembrolizumab to patients with cutaneous T-cell lymphoma is feasible.

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.Check my eligibility

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.See study design

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 agree to use birth control during and for 4 months after the study.

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

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My organs are working well.

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My cancer is between stages IB and IIIB.

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I agree to use condoms during the study and for 4 months after the last dose.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medical Devices

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor

47 Previous Clinical Trials

2,014 Total Patients Enrolled

Andreas G Niethammer, MD PhDStudy DirectorSorrento Therapeutics, Inc.

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04118868 — Phase 1

Mycosis Fungoides Research Study Groups: All participants

Mycosis Fungoides Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04118868 — Phase 1

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04118868 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been administered with the aid of Sofusa® DoseConnect™ in other research?

"Currently, 961 trials are being conducted involving the administration of Pembrolizumab with Sofusa® DoseConnect™. 122 of these medical studies are in Phase 3. 35731 locations across the world have been identified as sites for running this treatment-related research and Houston, Texas is a major hub."

Answered by AI

What illnesses does the Sofusa® DoseConnect™ method of administering Pembrolizumab treat?

"Pembrolizumab delivered via Sofusa® DoseConnect™ is a common intervention for malignant neoplasms, as well as unresectable melanoma, microsatellite instability high, and cases of chemotherapy resistance."

Answered by AI

How does the Sofusa® DoseConnect™ impact Pembrolizumab's risk profile for patients?

"Our team at Power provided a rating of 1 for the safety profile of Pembrolizumab administered using Sofusa® DoseConnect™, as this is the initial stage in clinical trials and there is scarce evidence to support its efficacy or protection."

Answered by AI

Are enrollees currently being accepted into this clinical research?

"Affirmative. Visiting clinicaltrials.gov reveals that this experiment, which was originally advertised on August 31st 2022, is actively seeking participants. 10 individuals are necessary for the trial to be conducted at a single medical site."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative. The clinicaltrials.gov portal discloses that this trial, launched on August 31st 2022, is currently recruiting participants. A total of 10 individuals are needed to be enrolled at 1 site."

Answered by AI

Recent research and studies

Frontiers in ImmunologyJournal

Reduction of T Lymphoma Cells and Immunological Invigoration in a Patient Concurrently Affected by Melanoma and Sezary Syndrome Treated with Nivolumab

Narducci, Maria Grazia, Anna Tosi, Alessandra Frezzolini, Enrico Scala, Francesca Passarelli, Laura Bonmassar, Alessandro Monopoli, et al.. 2020. “Reduction of T Lymphoma Cells and Immunological Invigoration in a Patient Concurrently Affected by Melanoma and Sezary Syndrome Treated with Nivolumab”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2020.579894.

clinicaltrials.govStudy

Pembrolizumab Administered Via the Sofusa® DoseConnect™ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma.

2022. "Pembrolizumab Administered Via the Sofusa® DoseConnect™ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04118868.