This phase 1/2 trial will investigate the safety of ALKS 4230 (ALKS) in advanced melanoma.
The main outcome will be adverse events and toxicities and disease control. This trial is recruiting at multiple locations in the US and Canada.
Melanoma or skin cancer is one of the most common cancers. The treatment options for advanced melanoma are limited. New drugs are in development to treat advanced cancer. Most of these drugs target different aspects of the immune system. This is because cancer cells can grow without being detected by the immune system. ALKS 4230 (ALKS) is an experimental drug. It is an engineered protein. It is similar to a natural protein called interleukin-2 (Il-2). ALKS activates Il-2 receptors and this stimulates immune cells to kill cancer cells.
This trial will investigate the safety of ALKS 4230 in advanced melanoma. The main outcome will be adverse events and toxicities.
Who are they looking for?
This trial will include 300 patients with advanced melanoma or other advanced solid tumors. Participants must have adequate bone marrow, liver and kidney function. They must also have completed any other cancer treatment. Women capable of bearing a child must have a negative pregnancy test during the trial. They must also use contraception to prevent pregnancy.
Pregnant or breast-feeding women cannot take part. Patients cannot take part in the trial if they have any active infections or sensitivities to the drugs in the trial. Patients with brain tumors or treatment-related autoimmune disorders are also excluded. Other exclusion criteria are uncontrolled illness, viral infection, altered QT interval (heart rate).
How will it work
Patients will be randomly assigned to one of two groups. One group will receive ALKS alone. The second group will receive ALKS and another drug, pembrolizumab (Keytruda). Pembrolizumab blocks a protein called PD-1 and enhances the immune system response to kill cancer cells. ALKS is administered intravenously (IV) for 5 days. Pembrolizumab is administered IV once every 3 weeks. Treatment will continue for up to 24 months.
The main outcome will be adverse events and toxicities related to treatment. Disease control and duration of response will also be measured.