Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases (NCT02374242) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases
Australia76 participantsStarted 2014-11-04
Plain-language summary
The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases.
Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age.
✓. Written informed consent
✓. 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 ≥ 5mm and ≤40mm measurable per RECIST version 1.1 guidelines.
✓. In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST \>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).
✓. No prior localised treatment for brain metastases (eg. surgery or radiotherapy).
✓. Neurologically asymptomatic from brain metastases.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, and life expectancy \> 30 days.
✓. Able to undergo MRI with Gadolinium contrast agent.
Exclusion criteria
✕2. Any melanoma brain metastasis \>40mm.
✕3. Ocular melanoma.
✕4. 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.
✕5. 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.
✕6. Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of ≤ 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 intraarticular steroid injections will be permitted.
✕7. Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half-lives from baseline.
✕8. Known to be HIV positive, or a positive test for hepatitis B and C .
✕9. Another malignancy or concurrent malignancy unless disease-free for 3 years.