Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases

Part of paid clinical trials in New York, New York.

Sponsor
Nicholas Gulati
Study ID
NCT05481658
Phase
PHASE1
Status
Recruiting

Conditions

  • Cutaneous Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diphencyprone (DPCP) — DRUG
    topical immunomodulator

Study Details

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.

Key Dates

Start date
Oct 6, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Diphencyprone (DPCP)
    0.4% and 0.04% ointment

Primary Outcome Measure

Proportion of subjects with a grade 3 adverse event [ Time Frame: at Day 98 or 128 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Nicholas Gulati (PRINCIPAL_INVESTIGATOR)

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