Cutaneous MetastasesPhase 1NCT05481658
Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases
A Phase 1 study testing Diphencyprone (DPCP) in people with Cutaneous Metastases, run by Nicholas Gulati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Metastases
- What is being tested?
- Diphencyprone (DPCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed cancer with at least three cutaneous metastasis sites that are able to be biopsied.
- Subject's oncologist plans as next standard of care treatment to use an FDA- approved PD-1 or PD-L1 ICI therapy. In other words, the subject would be treated with PD-1 or PD-L1 ICI therapy even if not taking part in this study. Subjects can be either ICI-naïve (never having received ICI previously), or may have progressed/relapsed during ICI therapy, but the treating oncologist has elected to continue PD-1 or PD-L1 ICI therapy.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately:
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
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- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subjects may not be receiving any other investigational agents.
- Subjects must not be receiving combination ICI, such as a PD-1 inhibitor with a CTLA-4 inhibitor.
- Subjects taking any of the following systemic therapies: corticosteroids, immunosuppressants, and/or any other medications (systemic or topical) that may affect the outcome of the study in the opinion of the investigator
- Subjects with any underlying diseases or dermatological conditions of the affected areas that require the use of interfering topical or systemic therapy, or that may, in the opinion of the investigator, impair immune responses such as HIV or lymphadenectomy of the axillary lymph node basin that drains the skin where DPCP is to be applied.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to DPCP, or any of the other components of the DPCP ointment formulation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Nicholas Gulati
About this study
Official title: 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
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
- Being tested
- Diphencyprone (DPCP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphencyprone (DPCP)Drug
Also called diphencyprone
topical immunomodulator
| Study group | Role | What they receive |
|---|---|---|
| Diphencyprone (DPCP) | Experimental | 0.4% and 0.04% ointment Receives: Drug: Diphencyprone (DPCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a grade 3 adverse event
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.
Measured: at Day 98 or 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start6 Oct 2022
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicholas Gulati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Gulati, Icahn School of Medicine at Mount Sinai
- Investigators
- Nicholas Gulati, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiPhilip Friedlander, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481658
- Sponsor's protocol ID
- STUDY-21-01421
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05481658
- Acronym / sponsor ID
- STUDY-21-01421
- Conditions
- Cutaneous Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nicholas GulatiUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diphencyprone (DPCP) | Experimental | Drug: Diphencyprone (DPCP)0.4% and 0.04% ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinically diagnosed cancer with at least three cutaneous metastasis sites that are able to be biopsied.
- Subject's oncologist plans as next standard of care treatment to use an FDA- approved PD-1 or PD-L1 ICI therapy. In other words, the subject would be treated with PD-1 or PD-L1 ICI therapy even if not taking part in this study. Subjects can be either ICI-naïve (never having received ICI previously), or may have progressed/relapsed during ICI therapy, but the treating oncologist has elected to continue PD-1 or PD-L1 ICI therapy.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately:
Key exclusion criteria (7 listed)
- Subjects may not be receiving any other investigational agents.
- Subjects must not be receiving combination ICI, such as a PD-1 inhibitor with a CTLA-4 inhibitor.
- Subjects taking any of the following systemic therapies: corticosteroids, immunosuppressants, and/or any other medications (systemic or topical) that may affect the outcome of the study in the opinion of the investigator
- Subjects with any underlying diseases or dermatological conditions of the affected areas that require the use of interfering topical or systemic therapy, or that may, in the opinion of the investigator, impair immune responses such as HIV or lymphadenectomy of the axillary lymph node basin that drains the skin where DPCP is to be applied.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to DPCP, or any of the other components of the DPCP ointment formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphencyprone (DPCP)Also: diphencypronetopical immunomodulator | Drug | Diphencyprone (DPCP) |
Primary outcome
Proportion of subjects with a grade 3 adverse event
Time frame: at Day 98 or 128
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Gulati, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Philip Friedlander, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diphencyprone (DPCP) in people with Cutaneous Metastases, run by Nicholas Gulati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicky K Wong, MS, CCRC (212-241-3288, vicky.wong@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a grade 3 adverse event (time frame: at Day 98 or 128). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.