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Adjuvant Low-dose Ipilimumab Plus Nivolumab in Resected Melanoma
NCT02941744Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2016
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- UZ Brussel
- Modality
- Monoclonal Antibodies
- Drugs
- ipilimumabnivolumab
- Conditions
- cutaneous melanoma (CM)
01
Overview
Phase 2, open-label, single-arm trial of ipilimumab and nivolumab in cutaneous melanoma (CM), sponsored by UZ Brussel. Primary endpoint: Number of participants with treatment-related adverse events at 2 years. Started Mar 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
IpNiv
Low fixed dose ipilimumab plus low fixed dose nivolumab
03
Who it enrols
Patients with completely resected Stage IIIb/c or Stage IV melanoma, ECOG 0-1, no prior systemic anti-cancer treatment, and no active autoimmune disease.
04
Endpoints
Primary
Number of participants with treatment-related adverse events
Secondary
Measure T cell repertoire before and after treatment
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