OncoMatch/Clinical Trials/NCT04349436
Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
Is NCT04349436 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies RP1, intra-tumoral for merkel cell carcinoma.
Treatment: RP1, intra-tumoral — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: local resection and/or radiation
Patients must have progressed or experienced recurrence from previous local resection and/or prior radiation
Cannot have received: oncolytic therapy
Prior treatment with an oncolytic therapy
Cannot have received: checkpoint inhibitor
Prior treatment with a ... checkpoint inhibitor
Cannot have received: radiation therapy
Radiation therapy within 14 days of first dose of RP1
Cannot have received: topical or any systemic therapy
topical or any systemic therapy within 30 days of the first dose of RP1
Cannot have received: botanical preparations
Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to the first dose and throughout the study
Lab requirements
Blood counts
Adequate hematologic function
Kidney function
Adequate renal function as indicated by a serum creatinine or estimated glomerular filtration rate (eGFR) determined based on the Chronic Kidney Disease-Epidemiology Collaboration equation
Liver function
Adequate hepatic function
Cardiac function
For cardiac transplant recipients: At least 50% ejection fraction with not more than an absolute change of 5% over the past 12 months. No evidence of hemodynamically or angiographically significant cardiac allograft vasculopathy (CAV) (i.e., patients must not have CAV2 or CAV3), or no ischemia by appropriate diagnostic imaging over the past 12 months.
Adequate allograft function as determined by functional testing and as confirmed by the transplant clinician. For renal transplant recipients, patients must have serum creatinine increase of < 30% mean increase over the past 6 months. For lung transplant recipients, patients must have stable forced exploratory volume in 1 second (FEV1) of at least 50% predicted with no more than a 10% decline in the absolute FEV1 over the past 12 months. For cardiac transplant recipients, patients must have: At least 50% ejection fraction with not more than an absolute change of 5% over the past 12 months. No evidence of hemodynamically or angiographically significant cardiac allograft vasculopathy (CAV) (i.e., patients must not have CAV2 or CAV3), or no ischemia by appropriate diagnostic imaging over the past 12 months. For patients with stable pancreas transplant, amylase and lipase should be ≤ 3 x upper limit of normal (ULN) for at least 6 months prior to enrollment. Adequate hepatic function. Adequate renal function as indicated by a serum creatinine or estimated glomerular filtration rate (eGFR) determined based on the Chronic Kidney Disease-Epidemiology Collaboration equation. Adequate hematologic function. Adequate coagulation parameters.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
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