Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05481658

Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases

Led by Nicholas Gulati · Updated on 2026-02-10

100

Participants Needed

1

Research Sites

425 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase I, open label study employing diphencyprone (DPCP) to characterize gene expression changes of various immune cell and tumor markers in cutaneous metastases treated with topical DPCP twice weekly for 12 weeks in combination with PD-1 or PD-L1 immune checkpoint inhibition (ICI), compared to pre-treatment cutaneous metastases and to describe the adverse events associated with DPCP when administered topically twice weekly for 12 weeks in combination with PD-1 or PD-L1 ICI.

CONDITIONS

Official Title

Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically diagnosed cancer with at least three cutaneous metastasis sites that are able to be biopsied.
  • Plan to receive FDA-approved PD-1 or PD-L1 immune checkpoint inhibitor therapy as next standard treatment.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2.
  • Women of child-bearing potential and men must agree to use adequate contraception before, during, and for 90 days after the study.
  • Ability to understand and willingness to sign a written informed consent.
Not Eligible

You will not qualify if you...

  • Receiving any other investigational agents.
  • Receiving combination immune checkpoint inhibition such as PD-1 inhibitor combined with CTLA-4 inhibitor.
  • Taking systemic corticosteroids, immunosuppressants, or other medications that may affect study outcomes.
  • Having underlying diseases or skin conditions in affected areas that require interfering treatments or impair immune response (e.g., HIV or certain lymph node surgeries).
  • History of allergic reactions to compounds similar to diphencyprone or its ointment components.
  • Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting study compliance.
  • Pregnant or nursing women due to potential risks to infants.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

V

Vicky K Wong, MS, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases | DecenTrialz