A phase II study assessing the intracranial response to nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases

Melanoma Institute Australia0 sites79 target enrollmentDecember 16, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 16, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Cohort 1 and 3
•Inclusion criteria
•1\. equal or greater than 18 years of age.
•2\. Written informed consent
•3\. AJCC Stage IV (any T, any N, M1c) histologically confirmed melanoma or unknown primary melanoma. Patients must have at least 1 radiological definitive brain metastasis that is equal or greater than 5mm and equal or less than 40mm measurable per RECIST version 1\.1 guidelines.
•4\. In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST greater than 20% or new measurable brain metastases) compared with nadir of intracranial response during BRAF inhibitor treatment, and confirmed with a second MRI brain scan at any time from the beginning of the drug washout period (dabrafenib \= 5 days, trametinib \= 14 days).
•5\. No prior localised treatment for brain metastases (eg. surgery or radiotherapy).
•6\. Neurologically asymptomatic from brain metastases.
•7\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\-2, and life expectancy greater than 30 days.
•8\. Able to undergo MRI with Gadolinium contrast agent.

•Exclusion criteria
•1\. Any melanoma brain metastasis greater than 40mm and any leptomeningeal disease, whether asymptomatic or not.
•2\. Ocular melanoma.
•3\. Prior treatment with an anti\-PD\-1 or anti\-PD\-L1 , anti\-PD\-L2, anti\-CD137, or anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways.
•4\. Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•5\. Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of less than or equal to 10 mg/day (or equivalent). Past treatment for non\-neurological symptoms allowed, if ceased 2 weeks prior to starting study
•treatment. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient on a stable dose. Non\-absorbed intra\-articular steroid injections will be permitted.
•6\. Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half\-lives from baseline.
•7\. Known to be HIV positive, or a positive test for hepatitis B and C.
•8\. Another malignancy or concurrent malignancy unless disease\-free for 3 years.