2024-516585-11-00
Recruiting
Phase 2
Efficacy of immunotherapy in melanoma patients with brain metastases treated with steroids. The MEMBRAINS trial
Region Hovedstaden3 sites in 1 country50 target enrollmentAugust 26, 2024
DrugsKEYTRUDA 25 mg/mL concentrate for solution for infusionOPDIVO 10 mg/mL concentrate for solution for infusion.MK-3475TRAMETINIBHLX13BAT3306BMS936558SCH-900475IBI310ABP 206DABRAFENIBBMS734016FYB206ENCORAFENIBABP 234LambrolizumabBINIMETINIBPabolizumabYERVOY 5 mg/ml concentrate for solution for infusion
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Region Hovedstaden
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- 6 months overall survival rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The project aims to prospectively evaluate the effect of anti-PD-1 antibodies alone or in combination with anti-CTLA-4 antibodies in patients with melanoma metastasized to the brain in need of steroid treatment
Investigators
Troels Holz Borch
Scientific
Region Hovedstaden
Eligibility Criteria
Inclusion 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 to brain metastasis
- •At least one measurable lesion according to RECIST version 1.1 guidelines
- •≥ 18 years of age
- •Performance status 0-2
- •Able to undergo MRI with gadolinium contrast agent
- •Adequate hematological and organ function
- •Signed statement of consent after receiving oral and written study information
Exclusion Criteria
- •Another malignancy or concurrent malignancy unless disease-free for 3 years
- •Ocular melanoma
- •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 anticancer drugs
Outcomes
Primary Outcomes
6 months overall survival rate
6 months overall survival rate
6 months progression-free survival rate
6 months progression-free survival rate
Secondary Outcomes
- Overall progression-free survival
- Overall survival
- Overall response rate according to modified RECIST 1.1
- Extracranial response rate in extracranial lesions according to modified RECIST 1.1
- Intracranial response rate in intracranial lesions according to modified RECIST 1.1
- 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
- Blood and tissue biomarkers of response and progression
Study Sites (3)
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