DABRAFENIB for Advanced melanoma | Malignant melanoma of skin

Inclusion criteria

• {"criterion_text":"- Histologically confirmed metastatic melanoma with radiologically verified brain metastasis"}
• {"criterion_text":"- Need for systemic steroid treatment (prednisolone > 10 mg daily; dexamethasone > 1.6 mg daily, hydrocortisone > 40 mg daily or equivalent) due to brain metastasis"}
• {"criterion_text":"- At least one measurable lesion according to RECIST version 1.1 guidelines"}
• {"criterion_text":"- ≥ 18 years of age"}
• {"criterion_text":"- Performance status 0-2"}
• {"criterion_text":"- Able to undergo MRI with gadolinium contrast agent"}
• {"criterion_text":"- Adequate hematological and organ function"}
• {"criterion_text":"- Signed statement of consent after receiving oral and written study information"}

Exclusion criteria

• {"criterion_text":"- Another malignancy or concurrent malignancy unless disease-free for 3 years"}
• {"criterion_text":"- Ocular melanoma"}
• {"criterion_text":"- Known hypersensitivity to one of the active drugs or excipients"}
• {"criterion_text":"- Acute or chronic infections with HIV or hepatitis"}
• {"criterion_text":"- Any medical condition that will interfere with patient compliance or safety"}
• {"criterion_text":"- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Simultaneous treatment with other experimental drugs or other anticancer drugs"}

Primary endpoints

• {"endpoint_text":"- 6 months progression-free survival rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6 months overall survival rate","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall progression-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall response rate according to modified RECIST 1.1","definition_or_measurement_approach":"According to modified RECIST 1.1"}
• {"endpoint_text":"- Extracranial response rate in extracranial lesions according to modified RECIST 1.1","definition_or_measurement_approach":"According to modified RECIST 1.1"}
• {"endpoint_text":"- Intracranial response rate in intracranial lesions according to modified RECIST 1.1","definition_or_measurement_approach":"According to modified RECIST 1.1"}
• {"endpoint_text":"- Intracranial clinical benefit rate (CR+PR+SD) – proportion of patients with an overall complete, partial response or stable disease ≥ 6 months according to modified RECIST 1.1","definition_or_measurement_approach":"Defined as proportion of patients with CR+PR+SD ≥ 6 months according to modified RECIST 1.1"}
• {"endpoint_text":"- Blood and tissue biomarkers of response and progression","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

16-07-2024

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

660

Number Of Sites

3

Number Of Participants

41

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}