This trial is examining the effectiveness of a new cancer vaccine. The main outcomes to be measured are cancer response and side effects. This trial is recruiting in New York and Tennessee, US.
The details
The standard treatment for most cancers is surgery and chemotherapy. However, chemotherapy has a limited effectiveness and a high rate of negative side effects.
Newer therapies such as immunotherapy have been commonly used to treat certain types of cancer. Immunotherapy such as nivolumab (Opdivo) or ipilimumab (Yervoy) stimulates the immune system to attack and kill cancer cells. Vaccines are a different kind of immunotherapy that helps telling the immune system which cells to attack (cancer cells). The neoantigen cancer vaccine is given in 2 steps, the prime vaccine (GRT-C901) followed by the boost (GRT-R902). The effect of these vaccines in lung and colorectal cancer is still not clear.
The main outcome to be measured in this trial is the immune system response to the vaccine.
Who are they looking for?
This study is recruiting 214 participants with either lung, colorectal, bladder or stomach advanced cancer. Patients must have adequate organ function tests.
Patients with lung cancer must not have abnormal genes. Patients with colorectal cancer must not have microsatellite instability disease (inability of the body to repair an abnormal gene). Patients with colorectal cancer must not have a BRAF mutation (an abnormal gene). Participants must not have any bleeding disorder.
How will it work
All patients will receive a sequence of the prime and boost of the cancer vaccine in combination with nivolumab and ipilimumab.
The vaccine dosing, safety and immune system response to it will be measured.
