Using diphencyprone with immune checkpoint inhibitors to treat skin cancer spread

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 study is testing if a topical treatment called diphencyprone can boost the effectiveness of immune therapies in helping people with skin cancer that has spread.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05481658 on ClinicalTrials.gov

What this trial studies

This phase I, open-label study investigates the effects of diphencyprone (DPCP) on gene expression changes in immune cells and tumor markers in patients with cutaneous metastases. Participants will receive topical DPCP twice weekly for 12 weeks alongside PD-1 or PD-L1 immune checkpoint inhibitors. The study aims to compare the treated metastases with pre-treatment samples and assess any adverse events related to DPCP. This approach seeks to enhance the immune response against skin cancer spread.

Who should consider this trial

Good fit: Ideal candidates include adults with clinically diagnosed cancer and at least three biopsy-able cutaneous metastasis sites who are scheduled to receive PD-1 or PD-L1 immune checkpoint therapy.

Not a fit: Patients who do not have cutaneous metastases or those who are not candidates for PD-1 or PD-L1 immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with cutaneous metastases by enhancing the effectiveness of immune checkpoint inhibitors.

How similar studies have performed: While the combination of DPCP with immune checkpoint inhibitors is a novel approach, similar studies have shown promise in enhancing immune responses in cancer treatment.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Nicholas Gulati, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Vicky K Wong, MS, CCRC

Conditions Cutaneous Metastases