Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
| Condition(s) | Melanoma Stage IV, Melanoma Stage III, Immunotherapy, Toxicity, Drug |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab |
| Who can participate | Inclusion Criteria: * 18 years of age or older * Irresectable stage III or metastatic melanoma * Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab: * previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed * in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy. * Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab: * for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline * for patients with PR on |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Erasmus Medical Center |
| Locations | Rotterdam, Netherlands |
| Start date | 2023-02-01 |
| NCT ID | NCT05652673 |
| Official listing | https://clinicaltrials.gov/study/NCT05652673 |