Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
NCT04349436 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL RP1, intra-tumoral injection, oncolytic virus
Study Locations (20)
California
- University of California, San Diego — La Jolla
- University of California, Los Angeles — Los Angeles
- UCSF, Helen Diller Family Comprehensive Cancer Center — San Francisco
Florida
- Mayo Clinic Florida — Jacksonville
- University of Miami Sylvester Comprehensive Cancer Center — Miami
- Moffitt Cancer Center — Tampa
Arizona
- Medical Dermatology Specialists — Phoenix
- Mayo Clinic Arizona — Phoenix
New York
- Columbia University Medical Center — New York
- Rochester Dermatologic Surgery — New York
North Carolina
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill
- Duke University — Durham
Ohio
- University of Cincinnati — Cincinnati
- The Cleveland Clinic Foundation — Cleveland
Colorado
- University of Colorado Cancer Center School of Medicine — Aurora
Illinois
- University of Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2029-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04349436
The ClinicalTrials.gov registry entry for NCT04349436 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Replimune, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which RP1, intra-tumoral injection, oncolytic virus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04349436 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04349436 about?
NCT04349436 is a clinical study titled "Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies". 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 ...
What is the current status of trial NCT04349436?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2020-05-15. Estimated completion is 2029-11.
What conditions does trial NCT04349436 study?
This clinical trial studies the following conditions: Cancer, Merkel Cell Carcinoma, Basal Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04349436?
The interventions under investigation include: RP1, intra-tumoral injection, oncolytic virus (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04349436?
This trial is sponsored by Replimune, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04349436 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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