Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma
Status:
Recruiting
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
Summary
Stage II patients with primary surgical treatment of cuMM are often at risk for recurrence of
their disease. This risk may be reduced by adjuvant systemic treatment. Due to toxicities of
adjuvant therapies the aim is to identify patients at high risk for relapse and to administer
adjuvant treatment only to these patients. Thus an optimal balance between insufficient
treatment vs. overtreatment has to be found.
To define these patients a prognostic biomarker test will be used in addition to conventional
AJCC staging. AJCC staging takes into account several prognostic factors. However, to
subdivide stage II melanoma patients into having a low or high risk for relapse further
methods are needed.
This clinical trial will evaluate whether adjuvant nivolumab treatment will improve
relapse-free survival (RFS) in patients with stage II high-risk melanoma as compared to
observation only. The randomized approach of this trial offers the most objective method with
the least influence of bias. Since patients with stage II melanoma are usually not receiving
adjuvant treatment, no patient will be undertreated in case of randomization into
observational arm.