This phase 2 trial will investigate the effectiveness and safety of ipilimumab (Yervoy) in combination with pembrolizumab (Keytruda) in patients with melanoma that has spread to the brain. The main outcome will be the clinical benefit rate and survival. The trial is recruiting in Texas, United States.
Melanoma is a cancer of the skin. In advanced melanoma, cells can migrate to other regions and form tumors. This is process is called metastasis. There are limited treatments for advanced melanoma with brain metastases. Immune checkpoint inhibitors (ICIs) are a new type of drug in development for advanced cancer. In some aggressive cancers, it can be difficult to kill all cancer cells with conventional treatment. Cancer cells can go undetected by the immune system. ICIs prevent this by blocking certain proteins and allow the immune system to detect and attack cancer cells. Ipilimumab and pembrolizumab are ICIs.Both drugs have been used individually to treat advanced melanoma.
This trial will investigate the effectiveness and safety of ipilimumab in combination with pembrolizumab in patients with melanoma and brain metastases. The main outcome will be the clinical benefit rate.
Who are they looking for?
This trial will include 30 patients with advanced melanoma.Patients must have brain metastases without neurological problems. Patients must have a life expectancy of more than 12 weeks. A tumor biopsy must be available for analysis. Patients must have adequate kidney and liver function tests and blood cell counts. Patients must agree to use contraception during the trial and for 120 days after.
Patients cannot be undergoing other cancer therapy and should not be pregnant or breastfeeding. Patients that have been treated with ICIs may not be suitable for the trial. Other exclusion criteria are cancer in other organs, auto-immune disease, infections, history of heart disease or stroke and brain metastases greater than 3 cm.
How will it work
All patients will be assigned to ipilimumab and pembrolizumab treatment. Both drugs will be administered intravenously. Treatment will be repeated every 3 weeks for a total of 4 courses of ipilimumab and up to 35 courses of pembrolizumab. Treatment can be halted if disease progression is absent. If there are unacceptable toxic effects treatment can be stopped. Clinical benefit rate will be measured by the brain tumor response. Survival will also be evaluated up to 1 year.