RecruitingPHASE3INTERVENTIONAL

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

This study, called IGNYTE-3, is for people aged 12 and older with advanced skin melanoma that has worsened after receiving specific previous treatments (anti-PD-1 and anti-CTLA-4 drugs). The study wants to see if a new treatment combination, Vusolimogene Oderparepvec (VO) and nivolumab, is more effective than standard treatments chosen by a doctor. This is a Phase 3 study, meaning it’s a big step towards potentially making this treatment widely available. Participants will be randomly assigned to receive either the new combination or one of the standard options, and doctors will carefully monitor their progress. The aim is to find better ways to manage advanced melanoma when other treatments haven't worked.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Replimune, Inc.

Enrolment target

400

Start

11 Jul 2024

Estimated completion

31 Aug 2034

Advanced Melanoma

What is this study about?

This study is about finding new and better ways to treat advanced melanoma, which is a serious type of skin cancer. Specifically, it's for people whose melanoma has continued to grow even after they've had two specific types of modern immunotherapy drugs. These drugs are called anti-PD-1 and anti-CTLA-4 treatments, and they work by helping your body's immune system fight the cancer. For some people, these treatments might not keep the cancer under control, and that's where this study comes in.

The main aim of this study is to compare a new treatment combination — Vusolimogene Oderparepvec (VO) with nivolumab — against current standard treatments chosen by your doctor. VO is a type of 'oncolytic virus', which means it's a specially designed virus that can infect and kill cancer cells, while also helping your immune system recognise and attack the cancer. Nivolumab is an anti-PD-1 drug, similar to one you might have already had. The study wants to see if combining these two treatments is more effective than other established treatments, such as nivolumab with another drug called relatlimab, pembrolizumab (another anti-PD-1 drug), or chemotherapy.

This is a Phase 3 study, which is the final stage before a new treatment can be considered for wider use. It means many people are taking part across different hospitals (multicenter study), and participants are randomly assigned to either the new treatment combination or a standard treatment. This helps make sure the results are fair and reliable. The results from studies like this are crucial for developing new medicines that can make a real difference to patients' lives.

Key takeaways

This study is for advanced skin melanoma that has worsened after specific immunotherapy drugs.
It compares a new combination treatment (VO + nivolumab) with standard doctor's choice treatments.
Patients must be at least 12 years old to participate.
It's a Phase 3 study, aiming to find better options for this type of melanoma.
Participants will be closely monitored by a medical team.

Who may be eligible?

This study is looking for people who are 12 years old or older. You would need to have skin melanoma that has spread or cannot be removed by surgery (this is called advanced melanoma). Importantly, your melanoma must have continued to grow despite having received previous treatments using two specific types of immunotherapy drugs (anti-PD-1 and anti-CTLA-4). These treatments could have been given together or one after the other. Your doctor would need to confirm that your cancer has progressed.

Even if you couldn't take the anti-CTLA-4 drug for health reasons, you might still be able to join if your cancer grew after an anti-PD-1 drug. Your doctor would need to judge if you're a good fit for the study. There are also other health checks and conditions that the study team will go through with you to make sure it's safe for you to take part.

Quick self-check

Are you 12 years old or older?
Do you have advanced melanoma that has spread or cannot be removed?
Has your melanoma grown despite having received anti-PD-1 and anti-CTLA-4 treatments?
Are you able to regularly visit the hospital for treatment and check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it means you'll be regularly seen by the study team. You'll have blood tests, scans, and other checks to monitor your health and how the treatment is working. Depending on which treatment group you are in, you'll receive either the new combination of VO and nivolumab, or one of the standard treatments chosen by your doctor. These standard treatments could include nivolumab with relatlimab, pembrolizumab, or chemotherapy.

The treatments are given over a period of time, and the study team will explain the schedule for your specific treatment. There will also be follow-up appointments after your treatment finishes to see how you are doing in the long term. The total duration of your participation in the study, including treatment and follow-up, will be explained in detail by the study staff.

Potential risks and benefits

Taking part in a study like this could offer a chance to try a new treatment that might be more effective than current options for your advanced melanoma. However, as with all medical treatments, there are potential risks, including side effects from the study drugs. The study team will explain all known and potential risks in detail, and you'll be closely monitored for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (81)

Banner MD Anderson Cancer Center
Gilbert, United States· Recruiting
UC San Diego Moores Cancer Center
La Jolla, United States· Recruiting
The Angeles Clinic and Research Institute
Los Angeles, United States· Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, United States· Recruiting
UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, United States· Recruiting
Stanford Cancer Institute
Palo Alto, United States· Recruiting
Sutter Medical Group
Sacramento, United States· Withdrawn
San Francisco Oncology Associates
San Francisco, United States· Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States· Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, United States· Recruiting
The Melanoma and Skin Cancer Institute
Englewood, United States· Recruiting

+69 more sites — see the official record for the full list.

Common questions

What is advanced melanoma?

Advanced melanoma means the skin cancer has spread to other parts of your body or cannot be completely removed by surgery.

What are 'anti-PD-1' and 'anti-CTLA-4' drugs?

These are modern immunotherapy medicines that help your body's own immune system fight cancer cells.

What is Vusolimogene Oderparepvec (VO)?

VO is a new type of treatment using a specially designed virus that attacks cancer cells and helps your immune system.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your ongoing medical care.

How to find out more

Clinical Trials at Replimune

clinicaltrials@replimune.com 1-781-222-9570 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.