This phase 2 trial will investigate the effectiveness of drug combinations including a new drug, spartalizumab (PDR001), in advanced melanoma. The main outcome will be the overall response rate.
The details
Patients with advanced melanoma have limited treatment options. Surgery may not be a treatment option for many of these patients. Developing drugs to treat advanced melanoma is crucial. Some drugs may be useful in combination. Spartalizumab is a new drug being developed to treat advanced cancer. It is an immune checkpoint inhibitor (ICI). ICIs target proteins on cancer cells that allow immune cells to recognize and kill cancer cells.
This trial will investigate the effectiveness of drug combinations including spartalizumabin advanced melanoma. The main outcome will be the overall response rate.
Who are they looking for?
This trial will recruit 135 patients with advanced melanoma. Patients with the V600-BRAF mutation (an abnormal gene) can take part in the trial on two conditions. These patients must have had prior treatment with an ICI and a V600BRAF inhibitor. A tumor sample must be available for screening prior to treatment in this trial.
Patients cannot take part in the trial if they have active brain tumors, infections or autoimmune diseases. Other exclusion criteria include recent vaccination, history of bone marrow transplant, allergy to study drugs or chronic steroid therapy.
How will it work
Patients will be assigned to one of three groups. Spartalizumab will be administered to all groups. The dose is 400 mg every 4 weeks via intravenous infusion. Group 1 will also receiveLAG525 intravenous infusion. Group 2 will also receive capmatinib (INC280).This will be taken orally. Group 3 will also take canakinumab (Ilaris). This will be taken via subcutaneous injection (under the skin). Patient survival and disease progression will be assessed during the trial. Patients will be evaluated for up to 3 years.
