Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
Public ClinicalTrials.gov record NCT04349436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.
Study identification
- NCT ID
- NCT04349436
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2020 (Actual)
- Primary completion
- Jul 2029 (Estimated)
- Completion
- Nov 2029 (Estimated)
- Last update posted
- Apr 22, 2026
2020 – 2029
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| University of California, San Diego | La Jolla | California | 92093 | — |
| University of California, Los Angeles | Los Angeles | California | 90024 | — |
| UCSF, Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| University of Colorado Cancer Center School of Medicine | Aurora | Colorado | 80045 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Rochester Dermatologic Surgery | New York | New York | 14564 | — |
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27708 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| University of Tennessee Medical Center at Knoxville | Knoxville | Tennessee | 37920 | — |
| University of Texas Southwestern | Dallas | Texas | 75235 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04349436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04349436 live on ClinicalTrials.gov.