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MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 420 to confirmed 423 · Primary completion date changed from estimate of Dec 2024 to Jan 12, 2024 · Completion date: Jan 2027 to Dec 19, 2028 · 1 morev7Show 4 more changesShow less
Enrollment target: estimated 420 to confirmed 423
Primary completion date changed from estimate of Dec 2024 to Jan 12, 2024
Completion date: Jan 2027 to Dec 19, 2028
Site details revised at 24 of 24 sites
MinorPrimary completion date: Jan 2025 to Dec 2024v6
MinorStudy sites: 19 to 24v5
MinorSite details revised at 13 of 19 sitesv4
MinorRe-verified, no change to tracked fieldsv3
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 20 to 19 · Start date changed from estimate of Jul 2021 to Jul 8, 2021 · Secondary endpoints: details revised at 4 of 18 entriesv2Show 3 more changesShow less
Study sites: 20 to 19
Start date changed from estimate of Jul 2021 to Jul 8, 2021
Secondary endpoints: details revised at 4 of 18 entries
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients. Patients will be randomized 1:1 to receive either 2 cycles of neoadjuvant ipilimumab 80 mg + nivolumab 240 mg every 3 weeks followed by a total lymph node dissection (TLND) and, if applicable, resection of in-transit metastases (arm A) versus standard upfront TLND +/- resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks (arm B). Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks for 46 weeks (11 cycles). In case of BRAF V600E/K mutation-positivity, patients from arm A with a pathologic partial or non-response (\>10% viable tumor) will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. Patients will be treated in the study in both arms until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, subject withdrawal of consent or until end of study treatment.
An interim analysis will be performed after 60 events have occurred. The data safety monitory board (DSMB) will be ad hoc consulted when unexpected toxicities are reported. Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institute's standards.