This is a clinical trial for adults who have been diagnosed with Melanoma or Non-Small Cell Lung Cancer (NSCLC).

The purpose of this study is to test the safety and efficacy of an investigational drug RP1 when it is injected into a tumor on its own as well as in combination with nivolumab for the treatment of certain types of solid tumors. 

RP1 is a herpes simplex virus that has been genetically changed to grow and destroy cancer cells. It also delivers a substance called GM-CSF, which signals the body’s immune system (which defends against disease) to attack the cancer. It has been changed to add a protein called “GALV” that helps the virus to spread from cell to cell. RP1 is considered investigational, which means it has yet been approved by the United States Food and Drug Administration (FDA).

Nivolumab is a type of immunotherapy. This type of treatment stimulates the body’s immune system to fight cancer cells. Nivolumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 activates T-cells to find and kill cancer cells. Nivolumab has been approved by the FDA for use in malignant melanoma, non-small cell lung cancer, kidney cancer, head and neck cancer, classical Hodgkin lymphoma, bladder cancer, and colorectal cancer.

The combination of RP1 and nivolumab is not approved by the FDA and is considered investigational.
   
Both study drugs are administered intravenously (through a vein in an arm). RP1 will be administered every 2 weeks for about 4 months for a total of 8 injections. Nivolumab will be administered when participants receive the second RP1 injection and again every 2 weeks for about 4 months along with the RP1 injection. If participants continue to tolerate treatment, they will then continue to receive nivolumab every month for an additional 21 doses for a total of up 29 doses. In some cases, it may be appropriate to continue receiving nivolumab every 2 weeks. Participants may have the option to receive additional 8 doses of RP1, if the study doctor thinks they would benefit.
   
Study participation is expected to last about 3 to 4 years, which includes participants' initial screening visit, treatment visits, and follow-up visits.