NCT06999980View on ClinicalTrials.gov

A Phase II, Randomised Clinical Trial of Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

PHASE2Not yet recruitingINTERVENTIONAL

Enrollment

297

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2037

Conditions

Cutaneous MelanomaMucosal Melanoma

Interventions

DRUG

Ipilimumab 3mg/kg and nivolumab 1mg/kg

Neoadjuvant for 2 doses on days 1 and 22

DRUG

Nivolumab 480mg and relatlimab 160mg and ipilimumab 1mg/kg

Neoadjuvant for 2 doses at days 1 and 29

DRUG

Nivolumab 480mg and relatlimab 160mg

Neoadjuvant for 2 doses on days 1 and 29

Trial Locations (1)

2065

Melanoma Institute Australia, Wollstonecraft

All Listed Sponsors

lead

Melanoma Institute Australia

OTHER

NCT06999980 - A Phase II, Randomised Clinical Trial of Nivolumab and Ipilimumab Combined With Relatlimab for Patients With Resectable Advanced Melanoma Identified as Poor Responders to Immunotherapy Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation) | Biotech Hunter | Biotech Hunter