Efficacy of immunotherapy in melanoma patients with brain metastases treated with steroids. The MEMBRAINS trial

Phase 2

Recruiting

• Conditions: Advanced melanoma

• Registration Number: 2024-516585-11-00
• Lead Sponsor: Region Hovedstaden

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6 months overall survival rate		6 months overall survival rate
6 months progression-free survival rate		6 months progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
Overall progression-free survival		Overall progression-free survival
Overall survival		Overall survival
Overall response rate according to modified RECIST 1.1		Overall response rate according to modified RECIST 1.1
Extracranial response rate in extracranial lesions 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 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		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		Blood and tissue biomarkers of response and progression

Trial Locations

Locations (3)

Region Hovedstaden; 🇩🇰 Herlev, Denmark

Aarhus Universitet; 🇩🇰 Aarhus N, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Region Hovedstaden

🇩🇰Herlev, Denmark

Troels Holz Borch

Site contact

004538689339

troels.holz.borch@regionh.dk