Actively Recruiting
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Led by Melanoma Institute Australia · Updated on 2026-02-19
494
Participants Needed
1
Research Sites
620 weeks
Total Duration
On this page
Sponsors
M
Melanoma Institute Australia
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is for patients with stage 3 cutaneous melanoma and patients with mucosal melanoma who are able to have surgery to remove all tumour deposits. To improve the chance that melanoma will not recurr, new experimental combinations of a type of treatment called immunotherapy will be given before surgery.
CONDITIONS
Official Title
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Male or female patients aged 18 years or older
- Clinically detectable or PET confirmed disease
- Disease that can be completely surgically removed without significant involvement of blood vessels, brain, or bone
- Concurrent primary disease and lymph node metastases allowed if fully resectable
- Up to 3 in-transit metastases permitted if fully resectable
- Tumor suitable for a new core biopsy for biomarker testing
- ECOG performance status of 0 or 1
- Adequate blood, liver, kidney, and endocrine function
- Expected life expectancy greater than 12 months
- Women of childbearing potential must agree to avoid pregnancy or breastfeeding during treatment
- Cohort 1: Confirmed cutaneous melanoma stage IIIB, IIIC, or IIID with no prior systemic treatment and biomarker test done within 14 days
- Cohort 2: Confirmed cutaneous melanoma stage IIIB, IIIC, or IIID with disease progression on or recurrence after anti-PD-1 therapy, no prior CTLA-4 or LAG-3 inhibitor treatment
- Cohort 3: Confirmed mucosal melanoma at any stage fully resectable, no prior systemic treatment
You will not qualify if you...
- Uveal melanoma
- Contraindication to relatlimab, ipilimumab, or nivolumab
- No prior systemic therapy except for cohort 2 which may have had anti-PD1 monotherapy only
- Immunodeficiency or recent systemic immunosuppressive therapy exceeding 10 mg prednisone daily
- Active autoimmune disease requiring systemic treatment in past 12 months except certain stable conditions
- Progressing additional cancer requiring treatment in past 3 years except some successfully treated skin or in situ cancers
- Known brain metastases or carcinomatous meningitis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV, active Hepatitis B or C, or active tuberculosis
- Significant uncontrolled cardiovascular disease including recent heart attack, stroke, severe arrhythmias, or heart failure
- Proteinuria >1+ on dipstick unless quantitatively less than 1 g/24 hours
- Conditions or treatments that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or breastfeeding females
- Medical or social conditions preventing attendance at scheduled assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
Research Team
M
Monica Osorio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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