ARTACUS – A Study Evaluating RP1 for the Treatment of Cutaneous Malignancies in Patients Who Have Had a Kidney, Liver, Heart, Lung, and/or a Hematopoietic Cell Transplant.
Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04349436
This is a Phase 1B/2 clinical trial to study the effects of the investigational oncolytic immunotherapy RP1 for the treatment of cutaneous malignancies in patients who underwent either a kidney, liver, heart, lung, or other solid organ transplant, or hematopoietic cell transplantation. Researchers will study the safety of this treatment in patients and also evaluate its ability to shrink tumors.
Who is this study for?
This study is for patients who have had either a kidney, liver, heart, lung or other solid organ transplant, or hematopoietic cell transplantation and have advanced cutaneous squamous cell carcinoma (CSCC).
Key eligibility criteria
You may be eligible for this study if you meet the following conditions:
• Have recurrent, locally advanced or metastatic CSCC
• Have at least 1 measurable lesion
• Have had a kidney, liver, heart, lung or other solid organ transplant, or hematopoietic cell transplantation
• Are at least 18 years old
• Do not have an active viral infection, including from HSV-1, hepatitis B (HBV), hepatitis C (HCV) or HIV
Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.
What to expect during the study
Patients will receive RP1 dose every 2 weeks for about one year.
The study has different sections. They are:
|Initial Screening||Up to 28 days|
|Treatment Period||About 12 months|
|Follow-up Period||Up to 3 years after your first dose of RP1|
IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.