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NCT05481658 · ClinicalTrials.gov registry record · Phase 1
Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases
A Phase 1 study of Cutaneous Metastases, sponsored by Nicholas Gulati.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05481658: Recruiting Phase 1 study of Cutaneous Metastases, sponsored by Nicholas Gulati.
NCT05481658 is a Phase 1 study of Cutaneous Metastases that is actively recruiting participants, run by Nicholas Gulati. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05481658, a Phase 1 study of Cutaneous Metastases, is actively recruiting participants, sponsored by Nicholas Gulati.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Safety and tolerability of dual-therapy DPCP plus immune checkpoint inhibition will be measured as the proportion of subjects with a grade 3 on the Common Terminology Criteria for Adverse Events (CTCAE) criteria for eczema, version 5.0.
Conditions Studied
Interventions
- DRUG Diphencyprone (DPCP)
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
What NCT05481658 shows while recruiting
NCT05481658 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Cutaneous Metastases appearing as the primary indexed condition, and to 1 intervention - of which Diphencyprone (DPCP) is the first listed.
NCT05481658 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05481658 about?
NCT05481658 is a clinical study titled "Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases". 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), compar...
What is the current status of trial NCT05481658?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2022-10-06. Estimated completion is 2030-12.
What conditions does trial NCT05481658 study?
This clinical trial studies the following conditions: Cutaneous Metastases.
What interventions are being tested in trial NCT05481658?
The interventions under investigation include: Diphencyprone (DPCP) (DRUG).
Who is sponsoring clinical trial NCT05481658?
This trial is sponsored by Nicholas Gulati, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05481658 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05481658's enrollment target sits among peer trials
100 547th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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