Melanoma Metastasized to the Brain and Steroids
ConditionMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInge Marie Svane
About this trial
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).
Eligibility criteria
Qualifiers
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 to brain metastasis
At least one measurable lesion according to RECIST version 1.1 guidelines
Evaluable intracranial disease
Disqualifiers
Another malignancy or concurrent malignancy unless disease-free for 3 years
Ocular melanoma
Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery
Known hypersensitivity to one of the active drugs or excipients
Trial design
Treatments tested in this trial
- Pembrolizumab Injection [Keytruda]
- Ipilimumab Injection [Yervoy]
- Nivolumab Injection [Opdivo]
- Encorafenib
- Binimetinib
- Dabrafenib
- Trametinib
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Inge Marie Svane
Lead sponsor
Herlev Hospital
Sponsor institution
Source ClinicalTrials.gov