Purpose of this Study
We are doing this study to find out if an experimental study drug called RP1 is a safe and effective treatment for your cancer. We want to know how the drug works on its own and when it is combined with a cancer drug called nivolumab.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with unresectable melanoma; OR
- Are diagnosed with cutaneous melanoma that is not responding to therapy; OR
- Are diagnosed with a non-melanoma skin cancer
- Have at least 1 tumor that is large enough to inject
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
This study is divided into 3 periods: the screening period, the study drug period, and the follow-up period.
If you choose to join this study, we will find out if you are eligible during the screening period. During this period, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws and give urine samples
- Have a heart scan (ECG)
- Have several images taken of your tumor(s) and organs (photographs and CT/MRI scans)
- Have a small biopsy done of your tumor, unless you have already had one recently
- Get a dose of the study drug alone injected into a tumor during the first week of the period
- Get a dose of the study drug and a dose of nivolumab infused (IV) two weeks later and receive this same drug combination every other week until the 14th week of the period (7 total doses of study drug + nivolumab)
- Get a dose of nivolumab alone after your final dose of the study drug + nivolumab
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
Principal Investigator
Georgia
Beasley
Protocol Number
PRO00106412
NCT ID
NCT03767348
Phase
I/II
Enrollment Status
Open to Enrollment