Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies (NCT04349436)
An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Medical Dermatology Specialists — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Medical Dermatology Specialists — Phoenix, Arizona
- Mayo Clinic Arizona — Phoenix, Arizona
- University of California, San Diego — La Jolla, California
- University of California, Los Angeles — Los Angeles, California
- UCSF, Helen Diller Family Comprehensive Cancer Center — San Francisco, California
- University of Colorado Cancer Center School of Medicine — Aurora, Colorado
- Mayo Clinic Florida — Jacksonville, Florida
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Dana Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic Rochester — Rochester, Minnesota
- Washington University in St. Louis — St Louis, Missouri
- Rochester Dermatologic Surgery — New York, New York
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Duke University — Durham, North Carolina
- University of Cincinnati — Cincinnati, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Oregon Health and Science University — Portland, Oregon
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- University of Tennessee Medical Center at Knoxville — Knoxville, Tennessee
- University of Texas Southwestern — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- Inova Schar Cancer Institute — Fairfax, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.