Replimune - IGNYTE 3 (Advanced Melanoma)

Purpose of this Study

We are doing this study to find out if an experimental study drug called RP1 (the study drug) is a safe and effective option for people who have advanced melanoma. We want to know how the study drug works when it is combined with a cancer drug called nivolumab in comparison to several other standard treatments for advanced melanoma (nivolumab + relatlimab OR nivolumab alone OR pembrolizumab alone).

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with melanoma
  • Have disease that is progressing after treatment
  • Have at least 1 tumor that is large enough to be injected and has not been treated (injected) previously
  • Have not received more than 2 types of previous treatment for melanoma and must not have been treated with an oncolytic virus
For more information, contact the study team at emily.bolch@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 choose to join the study and are found to be eligible, you will get a random assignment (fair, equal chance) to 1 of 2 groups. You have a 50% chance of being assigned to either group. You will either:
  • Get the study drug (an injection into the tumor) and nivolumab (an IV through a vein in your arm) every 2 weeks; OR
  • Get 1 of the following 3 treatment options (whichever the study doctor believes is most appropriate): nivolumab + relatlimab together OR nivolumab alone OR pembrolizumab alone (an IV through a vein in your arm) every 3 weeks
You will have tumor measurements every 12 weeks. If you are able to tolerate the treatment during the study drug period, you will continue to receive treatments for up to 24 months.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician’s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen (IGNYTE-3)

Principal Investigator

Georgia
Beasley

Protocol Number

PRO00115292

NCT ID

NCT06264180

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov