Clinical Trial Details
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NCT03563729 : Melanoma Metastasized to the Brain and Steroids
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically confirmed metastatic melanoma with radiologically verified brain

- 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.

Exclusion Criteria:

- 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

- Acute or chronic infections with HIV or hepatitis

- Any medical condition that will interfere with patient compliance or safety

- 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

- Pregnant or breastfeeding females.
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