?This phase 1/2 trial aims to test the safety and effectiveness of treatment with ipilimumab (Yervoy) in combination with granulocyte macrophage colony stimulating factor (GM-CSF) in patients with stage 3 or 4 melanoma. The main outcome to be measured will be the response of the tumors to treatment. This trial is recruiting in Louisville, Kentucky (US).
The details
Both ipilimumab and GM-CSF are immunotherapies. These treatments stimulate the immune system to attack and kill melanoma cancer cells. It is not clear whether they are safe and effective when used in combination.
The current trial will examine combination treatment with ipilimumab and GM-CSF in patients with melanoma that has spread and cannot be surgically removed. The main outcome will be measured through the response of the immune system.
Who are they looking for?
This trial will recruit 42 participants with stage 3c and 4 melanoma and life expectancy of at least 3 months. Patients must have normal blood, liver and kidney laboratory results. Patients should not have been treated with ipilimumab before, received radiation therapy or steroids within 2 weeks of entering the study. Should not have colitis or HIV, be pregnant or have any other conditions that could interfere with the study.
How will it work
Patients will be treated with intravenous (IV, through a vein) ipilimumab followed by subcutaneous (injection under the skin) GM-CSF, for up to 4 cycles (4 weeks). The change in the immune-related overall response rate will be determined following the last treatment with ipilimumab.
