AN OPEN-LABEL PHASE IB/II STUDY OF RP1 IN SOLID ORGAN AND HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH ADVANCED CUTANEOUS MALIGNANCIES [ARTACUS] RPL-003-19

This study involves skin cancer treatment for patients who have had either a kidney, liver, heart and/or a lung or other solid organ transplant or a hematopoietic cell transplant. 
This trial is being done to look at the effects of RP1 in kidney, liver, heart, lung, solid organ and hematopoietic cell transplant recipients with advanced skin cancer. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to allow the virus to grow and destroy cancer cells, spread selectively from tumor cell to tumor cell, and activate the immune system to attack cancer cells. RP1 has also been genetically changed so that it cannot divide efficiently in normal cells.

for more information, visit: https://www.clinicaltrials.gov/study/NCT04349436

Inova Schar Cancer Institute
A Division of Inova Fairfax Medical Campus
8081 Innovation Park Drive
Fairfax, VA 22031

• Male or female ≥ 18 years of age prior to signing informed consent
• Solid organ or allogeneic hematopoietic cell transplant patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue, or lymph nodes) cutaneous malignancies including CSCC, BCC, Merkel cell carcinoma (MCC), and melanoma. Note: Hematopoietic cell transplant type must be allogeneic and have occurred > 12 months prior to dosing
• Disease progression following local resection and/or prior radiation, and have received no more than 1 prior systemic therapy
• At least 1 measurable tumor of ≥ 1 cm in longest diameter or ≥ 1.5 cm in shortest diameter for lymph nodes and injectable lesions which in aggregate comprise ≥ 1 cm in longest diameter
• Adequate function in the end organ of transplantation as confirmed by the transplant clinician
• Adequate hepatic and hematologic function
• Additional eligibility in protocol.

• Prior treatment with an oncolytic therapy
• Pregnancy or breastfeeding
• Visceral metastases
• Patients requiring cytotoxic T-lymphocyte antigen 4-Ig (CTLA-4-Ig) medications
• Patients with an active, known, or suspected autoimmune disease that requires systemic immunosuppressive treatment beyond immunosuppressive medications required for maintenance of allograft rejection prevention. Patients with vitiligo, childhood asthma that has resolved, type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment are permitted to enroll
• Patients with a history of any positive test result for hepatitis B virus (HBV) or hepatitis C (HCV) indicating the presence of the virus, e.g., hepatitis B surface antigen [HbsAg] positive or hepatitis C antibody (anti-HCV) positive (except if HCV RNA negative), or human immunodeficiency virus (HIV) positive. Patients with a history of HBV or HCV must have undetectable viral load within 3 months of study entry. Note: Testing for hepatitis B, hepatitis C, or HIV is not required unless mandated by local health authorities
• A history of transplant-related viral infections requiring treatment or modification to immunosuppression, such as BKV, EBV, or CMV within 3 months of study entry
• Documented history of allergic reactions or acute hypersensitivity reaction attributed to RP1 or to any of the excipients
• 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
• Active or history of leptomeningeal disease or brain metastasis
• Additional ineligibility in protocol.