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OncoMatch/Clinical Trials/NCT06999980

Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)

Is NCT06999980 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for cutaneous melanoma.

Phase 2RecruitingMelanoma Institute AustraliaNCT06999980Data as of May 2026

Treatment: 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 mgThis 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage IIIB, IIIC, IIID

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-1 therapy — neoadjuvant or adjuvant

Disease progression on neoadjuvant anti-PD-1 monotherapy, where progressed disease is completely resectable or, disease recurrence on adjuvant anti-PD-1 monotherapy, where recurrent disease is completely resectable

Cannot have received: CTLA-4 inhibitor

No prior treatment with CTLA-4 or LAG-3 inhibitors

Cannot have received: LAG-3 inhibitor

No prior treatment with CTLA-4 or LAG-3 inhibitors

Cannot have received: anti-PD-1 therapy

Exception: Cohorts 1 and 3 only; cohort 2 permitted prior anti-PD-1 monotherapy

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.

Cannot have received: anti-PD-L1 therapy

Exception: Cohorts 1 and 3 only

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.

Cannot have received: anti-CTLA-4 therapy

Exception: Cohorts 1 and 3 only

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.

Cannot have received: anti-LAG-3 therapy

Exception: Cohorts 1 and 3 only

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.

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Uncontrolled or significant cardiovascular disease including MI, stroke, arrhythmias, QTc > 480 ms, NYHA III-IV CHF, pericarditis, significant stent occlusion, poorly controlled venous thrombosis, myocarditis, or daily supplemental oxygen requirement

Adequate haematological, hepatic, renal and endocrine function. Uncontrolled or significant cardiovascular disease including, but not limited to any of the following: Myocardial infarction (MI) or stroke/transient ischemic attack within the 6 months prior to consent, Uncontrolled angina within the 3 months prior to consent, Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), QTc prolongation > 480 ms, History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombosis, etc), Cardiovascular disease-related requirement for daily supplemental oxygen, History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure), Patients with history of myocarditis, regardless of aetiology.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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