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Brief Title: Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
Official Title: Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA
Study ID: NCT04949113
Brief Summary: 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.
Detailed Description:
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Angeles Clinic, Los Angeles, California, United States
MD Anderson Cancer Center, Houston, Texas, United States
Melanoma Institute Australia (MIA), Sydney, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, , Australia
Lake Macquarie Private Hospital, Gateshead, , Australia
Alfred Health, Melbourne, , Australia
Peter MacCallum Cancer Center, Melbourne, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Tasman Oncology, Southport, , Australia
Westmead Hospital, Sydney, , Australia
Netherlands Cancer Institute, Amsterdam, NH, Netherlands
Amsterdam University Medical Center - location VUmc, Amsterdam, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Zuyderland Medisch Centrum, Heerlen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Radboud University Medical Center, Nijmegen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Isala Hospital, Zwolle, , Netherlands
Name: Christian Blank, Prof
Affiliation: Medical oncologist/researcher
Role: STUDY_CHAIR
Name: Georgina Long, Prof
Affiliation: Medical oncologist/researcher
Role: STUDY_CHAIR