ARTACUS (Skin Cancers in Organ Transplant Recipients)

Purpose of this Study

We are doing this study to learn more about the effects of an experimental drug called RP1 (the study drug) for organ transplant recipients who have an advanced form of skin cancer.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have received a liver, kidney, heart, lung, or other solid organ transplant
  • Are diagnosed with an advanced form of skin cancer
  • Have a tumor large enough to receive and injection
  • Have stable transplant status
For more information about who can join this study, please contact the study team at erin.campo@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you join this study, you will:
  • Be treated with the study drug for 1 year (the study drug is given as injections directly into tumors)
  • Return to the clinic for follow-up visits for 2 years after you finish taking the drug
  • Have physical exams
  • Answer questionnaires
  • Have electrocardiograms (ECG) performed
  • Have tumor biopsies done
  • Give blood samples
  • Have MRI and CT scans

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

An Open-Label, Multicenter, Phase 1B/2 study of RP1 in Solid Organ
Transplant Recipients with Advanced Cutaneous Malignancies

Principal Investigator

Meenal
Kheterpal

Protocol Number

PRO00104981

NCT ID

NCT04349436

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov