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

Identifier: 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 ScreeningUp to 28 days
Treatment PeriodAbout 12 months
Follow-up PeriodUp 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.

Contact Email: clinicaltrials@replimune.com
Contact Email: artacustrial@replimune.com
Contact Phone Number: +1 (781) 222 9570

Replimune’s investigational products and their uses are investigational, have not been proven to be safe and have not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.