What is the mechanism of action of this treatment?

Common treatments for metastases often involve a combination of topical immunotherapy and immune checkpoint inhibitors (ICIs). Topical immunotherapy, such as Diphencyprone (DPCP), induces a local immune response that helps recruit immune cells to the tumor site. ICIs, like PD-1 or PD-L1 inhibitors, block inhibitory pathways in T-cells, restoring their ability to target and destroy cancer cells. This combination enhances the overall immune response against metastatic cancer cells, potentially improving treatment efficacy and patient outcomes.

What side effects are associated with this type of intervention?

The combination of Diphencyprone (DPCP) and PD-1 or PD-L1 immune checkpoint inhibitors (ICI) for treating metastases can lead to several side effects. Topical DPCP often causes local skin reactions such as redness, itching, and blistering. Immune checkpoint inhibitors are associated with immune-related adverse events affecting various organs, including skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), liver inflammation (hepatitis), endocrine disorders (thyroiditis, adrenal insufficiency), and lung inflammation (pneumonitis). Combining these treatments may increase the likelihood of these side effects.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors (ICIs) such as pembrolizumab, nivolumab, and ipilimumab for the treatment of various metastatic cancers, including non-small cell lung cancer, esophageal cancer, and melanoma. These drugs enhance the anti-tumor immune response by blocking inhibitory pathways in T-cells. While topical immunotherapy agents like Diphencyprone (DPCP) are being studied for their ability to induce a local immune response, the combination of DPCP with ICIs aims to synergize local and systemic immune activation to combat metastases more effectively.

What other types of research exist?

Promising novel alternatives to Diphencyprone (DPCP) combined with PD-1 or PD-L1 immune checkpoint inhibitors (ICI) for metastases patients include: 1) Sipuleucel-T, an active cellular immunotherapy that has shown improved survival in castration-resistant prostate cancer. 2) Combination therapies involving ipilimumab (CTLA-4 inhibitor) with PD-1 inhibitors like nivolumab, which have demonstrated durable responses in various cancers. 3) Experimental therapies such as chimeric antigen receptor (CAR)-T cell therapies, which are being tested in clinical trials and show potential for robust anti-tumor activity.

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Immunomodulator

Diphencyprone + Immunotherapy for Skin Cancer

Phase 1

Recruiting

Led By Nicholas Gulati, MD, PhD

Research Sponsored by Nicholas Gulati

Eligibility Criteria Checklist

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

Must have

Subject's oncologist plans as next standard of care treatment to use an FDA-approved PD-1 or PD-L1 ICI therapy

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Subjects must not be receiving combination ICI, such as a PD-1 inhibitor with a CTLA-4 inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 98 or 128

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a skin-applied cream called DPCP on patients with skin tumors. The cream aims to boost the immune system's ability to fight cancer, used together with other drugs that help the immune system recognize cancer cells. DPCP is often used in topical immunotherapy for conditions like alopecia areata, where it helps induce an immune response.

Who is the study for?

Adults with skin cancer and at least three cutaneous (skin) metastases, who are planned to receive FDA-approved PD-1 or PD-L1 immune checkpoint inhibitors. They must be in a relatively stable condition (ECOG 0-2), able to consent, and use contraception. Excluded are those on certain other treatments like steroids, allergic to DPCP components, pregnant/nursing women, individuals with HIV or specific lymph node removals affecting the treatment area.

What is being tested?

The study is testing the effect of a topical drug called Diphencyprone (DPCP) applied twice weekly for 12 weeks alongside standard immune checkpoint inhibitors. It aims to observe changes in gene expression in treated skin cancer metastases and document any adverse events from this combination therapy.

What are the potential side effects?

Potential side effects include local skin reactions where DPCP is applied such as redness, itching or blistering. Systemic side effects may occur due to immune checkpoint inhibition which can range from flu-like symptoms to more serious conditions involving the lungs, liver, intestines, hormone glands or other organs.

Eligibility Criteria

Inclusion Criteria

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

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My next treatment is an FDA-approved immune therapy.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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I have skin cancer spread to at least three places that can be biopsied.

Exclusion Criteria

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not on a combination of immune checkpoint inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 98 or 128

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 98 or 128

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 98 or 128 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of subjects with a grade 3 adverse event

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: Diphencyprone (DPCP)Experimental Treatment1 Intervention

0.4% and 0.04% ointment

0 / 6Eligibility 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

Common treatments for metastases often involve a combination of topical immunotherapy and immune checkpoint inhibitors (ICIs). Topical immunotherapy, such as Diphencyprone (DPCP), induces a local immune response that helps recruit immune cells to the tumor site. ICIs, like PD-1 or PD-L1 inhibitors, block inhibitory pathways in T-cells, restoring their ability to target and destroy cancer cells. This combination enhances the overall immune response against metastatic cancer cells, potentially improving treatment efficacy and patient outcomes.

Immune Responses against Disseminated Tumor Cells.The Role of Membrane Bound Complement Regulatory Proteins in Tumor Development and Cancer Immunotherapy.A New Era of Immunotherapy in Prostate Cancer.