An Open-Label Multicenter Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Brief description of study

The purpose of this study is to see how well RP1 is tolerated by the body and to determine the safest dose of RP1 for future studies. This study will also test the safety and efficacy of RP1 when it is injected into your 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 (a microscopic life form commonly known as the “cold sore virus”) that has been genetically changed to grow in 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 also been changed to add a protein called “GALV” that helps the virus to spread from cell to cell. This will be the first time that RP1 will be used in humans and the purpose of this study is to learn about the safety and good or bad effects it has on you and your cancer. Nivolumab, which is approved in the USA, UK, and some other countries, to treat several different cancers, but it may not be approved to treat your type of cancer. In the USA, nivolumab has been approved for use in malignant melanoma, non-small cell lung cancer, kidney cancer, head and neck cancer, classical Hodgkin lymphoma, bladder cancer, and colorectal cancer. 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.


Clinical Study Identifier: s17-01386
ClinicalTrials.gov Identifier: NCT03767348
Principal Investigator: Anna C Pavlick
Currently Recruiting

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