Efficacy of immunotherapy in melanoma patients with brain metastases treated with steroids

Phase 1

Conditions: Metastatic melanoma with brain metastasis
MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-000875-34-DK

Lead Sponsor: ational Center for Cancer Immune Therapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;Primary end point(s): -6 months progression-free survival rate <br>-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 Outcome Measures

Name	Time	Method
Secondary end point(s): -Overall progression-free survival<br>-Overall survival<br>-Overall response rate according to modified RECIST 1.1<br>-Extracranial response rate in extracranial lesions according to modified RECIST 1.1<br>-Intracranial response rate in intracranial lesions according to modified RECIST 1.1<br>-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<br>-Blood and tissue biomarkers of response and progression;Timepoint(s) of evaluation of this end point: After all patients have ended treatment.