Melanoma Metastasized to the Brain and Steroids

Korábbi kezelés

• Another malignancy or concurrent malignancy unless disease-free for 3 years
• Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery
• Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
• Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
• Simultaneous treatment with other experimental drugs or other anti-cancer drugs
• For arm E specifically: Prior treatment with BRAF/MEK inhibitors.

Más betegség

• Known hypersensitivity to one of the active drugs or excipients
• Acute or chronic infections with HIV or hepatitis
• Any medical condition that will interfere with patient compliance or safety

Egyéb

• Ocular melanoma
• Pregnant or breastfeeding females.

• 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
• 18 years of age or older
• Performance status 0-2
• Able to undergo MRI with gadolinium contrast agent
• Adequate hematological and organ function
• No significant toxicity from previous cancer treatments (CTC\<1)
• Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
• Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
• Signed statement of consent after receiving oral and written study information.
• Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
• For arm E specifically: Tumor cells must harbor BRAF mutation.