Study

Testing a New Cancer Treatment Alone or With Pembrolizumab in Adults with Advanced Solid Tumors

This study is testing a new drug called mRNA-4359, given alone or with pembrolizumab. We want to learn how safe these drugs are and find the best dose for people with cancer that has spread, returned, or is hard to treat.

Why this Research Matters

A vaccine helps teach your immune system how to fight a disease. This study uses mRNA, a natural substance found in your cells, that tells your body how to make certain proteins. These proteins may help activate immune cells called T cells so they can better find and attack cancer cells. The study drug is still being tested and has not been approved by the FDA yet. Pembrolizumab is a medicine that blocks certain receptors on your cells which helps your immune system fight your cancer. This study will see if giving these two drugs together is safe and helps your immune system kill more cancer cells. If you join this study, you will be placed in 1 of 2 groups based on the type of cancer you have and past treatment. The first group will get mRNA-4359 (study drug) at different doses with pembrolizumab at the same dose. The second group will get both mRNA-4359 and pembrolizumab at the same dose. The study drug will be given as an injection into your muscle in your shoulder, thigh or buttock every 3 weeks for up to 6 months. Pembrolizumab will be given through a vein every 6 weeks for up to 2 years. You will have 15 in-person visits. At most visits, the study team will review your medical history, perform a physical exam, check your heart with an ECG, and collect blood samples. At some visits, you will fill out surveys, have imaging scans (CT, MRI, or PET scan) to check your cancer, and have a small piece of your tumor removed (biopsy). The study team will closely monitor your health and any side effects. You and your insurance will need to pay for routine medical care. You will not be paid to take part in the study, but you may be able to get reimbursement for travel or lodging.

Who can Participate

Adult

You may be able to join this study if you are at least 18 years old and have advanced melanoma or non-small cell lung cancer that has worsened despite immunotherapy treatment. You must have measurable cancer on scans, be able to provide tumor biopsy samples if medically possible, and have cancer that either never responded to immunotherapy or stopped responding after initially improving. The study team will review all requirements needed to join this study. You can visit ClinicalTrials.gov to learn more about this study.