This trial aims to investigate adding tocilizumab (Actemra) to treatment with ipilimumab (Yervoy) and nivolumab (Opdivo) for patients with advanced melanoma. The main outcome that will be measured is how the tumor size changes. The study is being conducted in New York, United States.
The details
Ipilimumab and nivolumab are well known anti-cancer drugs. Tocilizumab is commonly used to treat rheumatoid arthritis. It is a medication which suppresses the immune system. It is not known if adding tocilizumab to treatment with ipilimumab and nivolumab will improve outcomes from cancer, or if it will be well tolerated by patients.
This trial is evaluating the effectiveness of combining tocilizumab, ipilimumab, and nivolumab to treat advanced melanoma. The main outcome that will be measured is how the tumor size changes.
Who are they looking for?
The study is recruiting 67 patients with melanoma that cannot be surgically removed. Patients must not have received prior anticancer treatment for metastatic disease. The patients must have normal lab test results and must be willing to give tumor tissue.
Patients must not be planning to get pregnant. Effective birth control must be used by all patients. Patients must not have any other illnesses or infections which may affect treatment. Steroids must not have been used for 14 days before the study.
How will it work
All patients in this study will all receive the same type of treatment. All of the patients will be treated with tocilizumab,ipilimumab, and nivolumab. The treatment will be split into two phases. In the first phase, the treatment cycles will be six weeks. There will be two cycles in the first phase. The second phase will involve treatment cycles of 12 weeks and may go on for one year.
