At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vusolimogene Oderparepvec (biological), Nivolumab (biological), Nivolumab + Relatlimab (biological), Pembrolizumab (biological)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Vusolimogene Oderparepvec — biological: Genetically modified Herpes Simplex Type 1 Virus. · Nivolumab — biological: Anti-PD-1 Monoclonal Antibody · Nivolumab + Relatlimab — biological: Nivolumab: Anti-PD-1 Monoclonal antibody. · Pembrolizumab — biological: A programmed death receptor-1 (PD-1)-blocking antibody indicated. · Single-agent chemotherapy — drug: Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study (IGNYTE-3) is for people aged 12 and over with advanced melanoma (skin cancer) that has spread or cannot be removed by surgery, and that got worse despite treatment with two types of immunotherapy called anti-PD-1 and anti-CTLA-4 drugs. It tests a treatment called VO, given together with nivolumab, compared with treatment chosen by the patient's own doctor. The sponsor is Replimune, Inc.
Who can take part
- Aged 12 or over, male or female
- Advanced melanoma (stage IIIb to IV) that cannot be removed by surgery or has spread
- Cancer got worse on anti-PD-1 and anti-CTLA-4 immunotherapy, either given together or one after the other
- Known BRAF V600 gene test result, or willing to have this test; people with a BRAF mutation should usually have already had BRAF-targeted treatment
- At least one tumour measuring 1 cm or more that can be injected
- Good enough blood, liver, kidney and blood-clotting function, based on blood tests
- Able to carry out day-to-day activities (performance status 0 to 1 for adults; a similar score for ages 12 to 17)
- Expected to live at least 3 months
- Agree to use highly effective contraception during treatment and for 6 months after, if able to have children
- Able and willing to give informed consent
Who may not be able to
- Melanoma that started in a mucous membrane (mucosal) or the eye (uveal)
- More than 2 courses of systemic (whole-body) treatment for advanced melanoma
- Hepatitis B or hepatitis C that has not been effectively treated
- Known HIV infection
- Active cold sore virus (herpes) infection, past serious herpes complications, or needing regular anti-herpes medicines such as acyclovir
- Serious infection needing treatment within the past 2 weeks
- Spinal cord compression or high risk of it
- Active cancer spread to the brain, unless already treated and stable on 2 later scans
- A blood test (LDH) more than twice the normal limit
- Major surgery in the past 2 weeks
- Another cancer in the past 3 years, apart from some curable skin, bladder or very early cancers
- Serious heart problems, stroke or heart attack within the past 6 months
- Past life-threatening reaction to immunotherapy, unless unlikely to happen again
- Other serious health or mental health problems that could affect safety or taking part
- Active autoimmune disease needing whole-body treatment
- Lung inflammation (pneumonitis) now or in the past that needed steroids
- Previous treatment with an oncolytic virus or injections directly into a tumour
- A live vaccine in the past 28 days
- Cancer treatment in the past 4 weeks, or not yet recovered from radiotherapy
- Taking part in another study drug trial in the past 4 weeks
- Needing more than 10 mg a day of steroid tablets (like prednisone) in the past 14 days
- Allergy to the study drugs or related medicines
- Herbal or traditional medicines in the past 2 weeks
- Detained or in hospital under legal order
What taking part involves
- • VO is injected directly into tumour(s)
- • Nivolumab is given by drip into a vein (infusion)
- • The comparison group receives treatment chosen by the patient's doctor (physician's choice)
Time commitment: Not stated — ask the trial team about how many hospital visits are needed, how long treatment lasts, and what else taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2024-07-11
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for advanced melanoma
- • Phase3 - 400 participants
- • This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with advanced melanoma
Where?
- • Liverpool - Clatterbridge Cancer Centre NHS Foundation Trust
- • London - Royal Free London NHS Foundation Trust - Royal Free Hospital
- • London - Guy's & St. Thomas' NHS Foundation Trust
- • London - The Royal Marsden NHS Foundation Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of treatment bef
What the study is looking for
- ✓I 1. Male or female who is 12 years of age or older at the time of signed agreement to take part.
- ✓I 2. Patients with confirmed by testing a sample unresectable or that has spread Stage IIIb through IV/M1a...
- ✓I 5. Has least 1 measurable tumor of ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes) and...
- ✓I 6. Has healthy blood, including:
- ✓White blood cell (WBC) count ≥ 2.0 × 109/L
Who cannot take part
- ✗E 3. Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known acute...
- ✗Note: Patients who have been effectively treated are eligible for randomization. Patients must be negative for HBsAg...
- ✗E 4. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by...
- ✗Note: Patients with sporadic cold sores may be randomly assigned if no active cold sores are present at the time of first...
- ✗E 6. Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial,...
See the full criteria
Where Is This Study? (5 UK sites)
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
Royal Free London NHS Foundation Trust - Royal Free Hospital
London NW3 2QG, United Kingdom
Guy's & St. Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Clinical Trials at Replimune
Sponsor contactCONTACT
