This phase 2 trial will investigate the safety and effectiveness of a new targeted therapy drug, INCMGA00012 in advanced melanoma.
The main outcome will be the overall response rate. This trial is recruiting in Texas, United States.
The details
Melanoma is a form of skin cancer. Some patients are diagnosed with advanced stage melanoma. Treatment options may not be very effective at this stage. New cancer drugs are in development for advanced cancer. Immune-checkpoint inhibitor (ICI) drugs are a new type of cancer drug. They block a pathway that cancer cells use to evade the immune system. INCMGA00012 is an experimental ICI drug. It targets a protein called PD-1.
This trial will investigate the safety and effectiveness of INCMGA00012 in advanced melanoma. The main outcome will be the overall response rate.
Who are they looking for?
This trial will recruit 160 patients. Patients with melanoma that cannot be surgically removed or that has spread are eligible for the trial. Participants must be willing to avoid pregnancy or fathering children during the study.
Patients cannot take part in the trial if they have been treated with other ICIs. Patients must not be undergoing anticancer therapy at present. Patients with active infections including viral infections and those with heart disease are excluded from the trial. Other exclusion criteria are brain metastases (tumors), lung disease, other cancers, and autoimmune disease.
How will it work
All patients taking part in the trial will receive the same treatment.INCMGA00012 will be administered intra-venously once every 4 weeks. Patients will be assessed for response to treatment and survival for up to 3 years.
The main outcome will be the overall response rate.
