Vidutolimod (CMP-001) is an investigational medication used in this clinical trial. It is administered directly into the tumor (intratumoral) and is being studied for its potential to help the immune system recognize and attack cancer cells. Vidutolimod is being tested in combination with another medication to see if it can improve the treatment outcomes for patients with certain types of advanced or metastatic cancer.

Cemiplimab is a medication given through an intravenous infusion. It is a type of immunotherapy known as a checkpoint inhibitor, which works by blocking a specific protein on immune cells. This action helps the immune system to better detect and fight cancer cells. In this trial, cemiplimab is used in combination with vidutolimod to evaluate their effectiveness together in treating advanced or metastatic cancer.

Advanced or Metastatic Cancer – This term refers to cancer that has spread from its original site to other parts of the body. It often involves multiple organs and tissues, making it more challenging to manage. The progression can vary depending on the type of cancer and the organs affected. Symptoms may include pain, fatigue, and weight loss, among others. The disease can affect the body’s ability to function normally as it advances.

Merkel Cell Carcinoma (MCC) – A rare and aggressive form of skin cancer that typically appears as a painless, flesh-colored or bluish-red nodule on sun-exposed skin. It tends to grow quickly and can spread to other parts of the body, including lymph nodes and internal organs. The exact cause is not fully understood, but it is often associated with a virus called Merkel cell polyomavirus. MCC is more common in older adults and those with weakened immune systems.

Cutaneous Squamous Cell Carcinoma (CSCC) – A common type of skin cancer that arises from the squamous cells in the outer layer of the skin. It often appears as a scaly red patch, open sore, or wart-like growth that may crust or bleed. CSCC can grow slowly but has the potential to spread to other parts of the body if not treated. It is primarily caused by prolonged exposure to ultraviolet (UV) radiation from the sun or tanning beds.

Basal Cell Carcinoma (BCC) – The most common form of skin cancer, originating in the basal cells of the skin. It usually appears as a small, shiny bump or nodule on areas of the skin that are frequently exposed to the sun, such as the face and neck. BCC grows slowly and rarely spreads to other parts of the body, but it can cause significant local damage if left untreated. It is primarily caused by long-term exposure to UV radiation.

Triple Negative Breast Cancer (TNBC) – A subtype of breast cancer that does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER-2/neu. This makes it more challenging to treat, as hormone therapies and drugs that target HER-2 are ineffective. TNBC tends to be more aggressive and is more likely to spread and recur. It is more common in younger women and those with a BRCA1 gene mutation.

Non-Small Cell Lung Cancer (NSCLC) – The most common type of lung cancer, accounting for about 85% of cases. It includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC typically grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. Smoking is the leading risk factor, but non-smokers can also develop NSCLC.