Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

423

Participants

Timeline

Start Date

July 8, 2021

Primary Completion Date

January 12, 2024

Study Completion Date

December 19, 2028

Conditions
Malignant Melanoma Stage III
Interventions
DRUG

Neoadjuvant ipilimumab + nivolumab

2 cycles ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by total lymph node dissection

DRUG

Adjuvant nivolumab

Upfront total lymph node dissection followed by 12 cycles of nivolumab (480mg) every 4 weeks.

Trial Locations (24)

2060

Melanoma Institute Australia (MIA), Sydney

77030

MD Anderson Cancer Center, Houston

90025

The Angeles Clinic, Los Angeles

Unknown

Princess Alexandra Hospital, Brisbane

Lake Macquarie Private Hospital, Gateshead

Alfred Health, Melbourne

Peter MacCallum Cancer Center, Melbourne

Fiona Stanley Hospital, Murdoch

Tasman Oncology, Southport

Westmead Hospital, Sydney

Amsterdam University Medical Center - location VUmc, Amsterdam

Amphia Ziekenhuis, Breda

Maxima Medisch Centrum, Eindhoven

Medisch Spectrum Twente, Enschede

University Medical Center Groningen, Groningen

Zuyderland Medisch Centrum, Heerlen

Medisch Centrum Leeuwarden, Leeuwarden

Leiden University Medical Center, Leiden

Maastricht University Medical Center, Maastricht

Radboud University Medical Center, Nijmegen

Erasmus Medical Center, Rotterdam

University Medical Center Utrecht, Utrecht

Isala Hospital, Zwolle

1066CX

Netherlands Cancer Institute, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER

NCT04949113 - Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma | Biotech Hunter | Biotech Hunter