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OncoMatch/Clinical Trials/NCT04562129

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients

Is NCT04562129 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Interleukin-2 and Ipilimumab for melanoma stage iii.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT04562129Data as of May 2026

Treatment: Interleukin-2 · Ipilimumab · NivolumabThe purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.

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Extracted eligibility criteria

Cancer type

Melanoma

Biomarker criteria

Allowed: BRAF V600

Patients with BRAF V600 mutant melanoma must have previously received BRAF targeted therapy for metastatic melanoma and later experienced disease progression. Patients who refuse or decline to receive BRAF targeted therapy or were intolerant of BRAF targeted therapy are eligible.

Disease stage

Required: Stage III, IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-1 therapy (nivolumab, pembrolizumab)

Must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) and later experienced disease progression.

Cannot have received: systemic therapy

Must not have received systemic therapy or radiotherapy (including SRS) within the preceding 3 weeks.

Cannot have received: radiotherapy

Must not have received systemic therapy or radiotherapy (including SRS) within the preceding 3 weeks.

Lab requirements

Blood counts

Must have normal organ and marrow function as specified per protocol.

Kidney function

Must have normal organ and marrow function as specified per protocol.

Liver function

Must have normal organ and marrow function as specified per protocol.

Cardiac function

No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina. Patients over 40 years old or with cardiac history require a negative or low probability cardiac stress test for ischemia within 8 weeks prior to registration.

Must have normal organ and marrow function as specified per protocol. No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina. ... negative or low probability cardiac stress test ... within 8 weeks prior to registration.

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

US trial sites

  • Moffitt Cancer Center · Tampa, Florida

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