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.
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 mg — 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.
Check if I qualifyExtracted 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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