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) — DRUGtopical 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
- Vicky K Wong, MS, CCRC212-241-3288
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Nicholas Gulati (PRINCIPAL_INVESTIGATOR) |
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