NCT05481658

Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases

A Phase I, Open Label Study Employing the Topical Immunomodulator Diphencyprone to Improve Efficacy of PD-1 or PD-L1 Immune Checkpoint Inhibition in the Treatment of Advanced Cancer With Cutaneous Metastases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nicholas Gulati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Cutaneous Metastases

Interventions

Type	Name	Description
DRUG	Diphencyprone (DPCP)	topical immunomodulator

Timeline

• Start date: 2022-10-06
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2022-08-01
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study