Melanoma Metastasized to the Brain and Steroids

This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).

Trial Details

NCT ID
NCT03563729
Phase
PHASE2
Sponsor
Inge Marie Svane
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Pembrolizumab Injection [Keytruda]
  • Ipilimumab Injection [Yervoy]
  • Nivolumab Injection [Opdivo]
  • Encorafenib
  • Binimetinib
  • Dabrafenib
Locations (sample)
  • Herlev, Capital Region, Denmark|55.72366,12.43998
  • Aarhus, Midt, Denmark|56.15674,10.21076
  • Odense, Syd, Denmark|55.39594,10.38831

Key Eligibility Criteria

  • Histologically confirmed metastatic melanoma with radiologically verified brain metastasis
  • Need for systemic steroid treatment (prednisolone \> 10 mg daily; dexamethasone \> 1.6 mg daily, hydrocortisone \> 40 mg daily or equivalent) due t…
  • At least one measurable lesion according to RECIST version 1.1 guidelines
  • Evaluable intracranial disease

For full eligibility, visit ClinicalTrials.gov.

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