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Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

NCT06999980 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2026-02-19

No results posted yet for this study

Summary

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

Interventions

DRUG

Ipilimumab 1mg/kg and nivolumab 3mg/kg

Neoadjuvant for 2 doses at days 1 and 22

DRUG

Pembrolizumab 200 mg

Neoadjuvant for 2 doses at days 1 and 22

DRUG

Ipilimumab 3mg/kg and nivolumab 1mg/kg

Neoadjuvant for 2 doses on days 1 and 22

DRUG

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

Neoadjuvant for 2 doses at days 1 and 29

DRUG

Nivolumab 480mg and relatlimab 160mg

Neoadjuvant for 2 doses on days 1 and 29

Sponsors & Collaborators

Principal Investigators

  • Georgina Long · Melanoma Institute Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2028-03-31
Completion
2038-01-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999980 on ClinicalTrials.gov