Diphencyprone Plus Immune Checkpoint Inhibition in the Treatment of Cutaneous Metastases

NCT05481658 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY-21-01421
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  at Day 98 or 128

Study Arms (1)

Diphencyprone (DPCP)

EXPERIMENTAL

0.4% and 0.04% ointment

Drug: Diphencyprone (DPCP)

Interventions

Diphencyprone (DPCP) DRUG

topical immunomodulator

Also known as: diphencyprone

Diphencyprone (DPCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicholas Gulati: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

diphenylcyclopropenone

Study Officials

• Nicholas Gulati, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Philip Friedlander, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicky K Wong, MS, CCRC

CONTACT

212-241-3288; vicky.wong@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: October 6, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Specify Other Mechanism PI to be contacted

Locations

US (1)