Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelanoma Institute Australia
About this trial
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.
Eligibility criteria
Qualifiers
1. Written informed consent
2. Male or female patients who are at least 18 years of age on the day of signing informed consent.
3. Clinically detectable disease, and/or RECIST version 1.1 defined disease, and/or disease confirmed on PET imaging.
4. Fully resectable disease defined as having no significant vascular, central nervous system or bony involvement. Only cases where a complete surgical resection leading to tumour free margins and which is safely achieved is considered "resectable".
Disqualifiers
1. Uveal melanoma
2. Any contraindication to the administration of relatlimab, ipilimumab or nivolumab
3. No prior systemic therapy, including treatment with prior anti-PD1/L1, anti-CTLA-4 or anti-LAG-3 therapy (cohorts 1 and 3), except for cohort 2 which will have received anti-PD1 monotherapy only.
Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)
Trial design
Treatments tested in this trial
- Ipilimumab 3mg/kg and nivolumab 1mg/kg
- Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg
- Nivolumab 480mg and relatlimab 160mg
- Ipilimumab 1mg/kg and nivolumab 3mg/kg
- Pembrolizumab 200 mg
Treatment groups
494 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Melanoma Institute Australia
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov