Replimune (Melanoma and Other Skin Cancers) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Melanoma and Other Skin Cancers with Solid Tumors

Who Can Participate in the Study?

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

For more information about who can join this study, please contact the study team at kayotta.johnson@duke.edu.

Age Group
Adults

What is Involved?

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

If you are eligible, you will proceed to the study drug period. During this period, you will:
- 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

If you are able to tolerate the treatment during the study drug period, you will continue to receive an infusion of nivolumab every 4 weeks for up to 20 months. You might also be eligible to be treated with the study drug again, which will depend on how your cancer responds to the first round of treatment.

The follow-up period will begin 30 days after you got your last dose of the study drug. This period involves visiting our clinic for check-ups 3 times over the course of about 3 months.

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
Surgical Oncologist
Protocol Number
IRB: PRO00106412
NCT: NCT03767348
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698