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Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma

Study acronym: NivoMela
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
    v12
  3. Site contacts updated at 4 of 20 sitesv11
  4. Primary completion date: Jun 2027 to Sep 2027
    • Study completion date: Jun 2027 to Jan 2028
    v10
  5. Site contacts updated at 8 of 20 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 2 of 20 sitesv8
  2. Eligibility criteria expanded, about 23 words
    • Study sites revised (20)
    v7
  3. Site details revised at 4 of 20 sitesv6
  4. Site details revised at 6 of 20 sitesv5
  5. Primary completion date: Jun 2020 to Jun 2027
    • Start date changed from estimate of Jun 2020 to Jul 1, 2020
    • Site details revised at 8 of 20 sites
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 20 of 20 sites
    v3
  7. Secondary endpoints revised (5)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04309409
Lead Sponsor University Hospital, Essen
Conditions
(from sponsor)		 Malignant Melanoma Stage II
Related terms Melanoma
Enrollment 374 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov