Metastatic melanoma with brain metastasis MedDRA version: 21.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Keytruda
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
Other descriptive name: pembrolizumab
Concentration unit: mg/ml milligram(
Sponsors
National Center for Cancer Immune Therapy
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 anti-cancer drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: Not applicable ;Primary end point(s): -6 months progression-free survival rate -6 months overall survival rate;Timepoint(s) of evaluation of this end point: When patients have been treated with study drugs for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: After all patients have ended treatment. | — |
Countries
Denmark
Contacts
Public ContactInformation Services
National Center for Cancer Immune Therapy
Outcome results
None listed