Condition: High-risk Melanoma · Sponsor: Uppsala University
1. Rational Every year, around 5,000 people in Sweden are diagnosed with malignant skin melanoma. In the early stages of malignant skin melanoma, the chance of cure with surgery is very good. At a later stage, when the melanoma has become thick and/or has spread, the risk of recurrence is greater despite radical surgery. Therefore, in these cases (even in cases of recurrence after radical surgery), additional treatment with immunotherapy is often given, as it has been shown to reduce the risk of recurrence. Immunotherapy is given for one year based on previous research studies, but it has not been investigated whether a shorter treatment period has the same effect. The hypothesis is that six months of treatment is equally effective, which would have several advantages. The main advantage of a shorter treatment period is that the risk of severe side effects is reduced. A shorter treatment period also means fewer hospital visits for patients. In addition, significant drug costs and other healthcare resources could be saved. 2. Aim/objective The aim of the study is to investigate whether 6 months of treatment with immunotherapy, in addition to radical surgery, for malignant skin melanoma at high risk of recurrence, is as effective in preventing recurrence as 12 months of treatment. Secondary objectives: To investigate overall survival after 6 versus 12 months of treatment with immunotherapy. To investigate the health economic effects of a shorter treatment. 3. Primar…
This description comes directly from the study's public registry record.
Gustav J Ullenhag, professor · +46-18-6110000 · Gustav.Ullenhag@IGP.uu.se
Leila Boukharta, MSc · +46-18-6110000 · Leila.Boukharta@Akademiska.se
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| Helsinki University Hospital | Helsinki, Finland | Recruiting |
| Kuopio University Hospital | Kuopio, Finland | Recruiting |
| Tampere University Hospital | Tampere, Finland | Recruiting |
| Turku University Hospital | Turku, Finland | Recruiting |
| Ålesund Hospital | Ålesund, Norway | Recruiting |
| Haukeland University Hospital | Bergen, Norway | Recruiting |
| Sorlandet Hospital | Kristiansand, Norway | Recruiting |
| Akershus University Hospital | Oslo, Norway | Recruiting |
| Oslo University Hospital | Oslo, Norway | Recruiting |
| Stavanger University Hospital | Stavanger, Norway | Recruiting |
| North Norway University Hospital | Tromsø, Norway | Recruiting |
| Trondheim University Hospital | Trondheim, Norway | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06488482