This phase 2 trial will investigate the effectiveness of combining relatlimab and nivolumab (Opdivo) to treat melanoma. The main outcomes will be a change in tumor size and response to treatment. This trial is recruiting in Pittsburgh, Pennsylvania, United States.
The details
Melanoma is a type of skin cancer. It begins in skin cells called melanocytes. Melanoma treatment depends on the stage of the disease. Some melanomas are difficult to treat. Some cancers can trick the immune system and grow without being killed. They can bypass ‘immune checkpoints’ by interfering with certain pathways. New drugs are being developed to address this. They are called immune checkpoint inhibitors (ICIs). One drug is relatlimab. It targets a protein called LAG3. By binding to this, the immune system can recognize and kill melanoma. Nivolumab is a drug that targets the PD-1 protein. PD-1 is highly expressed on some tumor cells. Binding to PD-1 allows the immune system s to recognize and kill cancerous cells.
This trial will investigate the effectiveness of combining relatlimab and nivolumab to treat melanoma. The main outcomes will be a change in tumor size and treatment response.
Who are they looking for?
This trial will recruit 42 patients with stage 3 or 4 melanoma who have not received treatment targeting the immune system. Patients cannot take part in the trial if they have an autoimmune disease or if they had prior treatment with ICIs . Patients with eye melanoma cannot take part.
How will it work
Patients will be separated into 3 groups. There are two phases to the study. In phase 1, one group will receive relatlimab. A second group will receive nivolumab. The third group will receive both relatlimab and nivolumab. All drugs will be administered intravenously. This will occur over 4 weeks. After the first phase, all patients will receive relatlimab and nivolumab combination.
