A Phase 1-2a Study of EVM14 Alone or With Pembrolizumab Immunotherapy in People With Advanced Solid Tumors

Full Title

A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination with Pembrolizumab in Patients with Selected Solid Tumors

Purpose

Researchers want to find the best dose of EVM14 when used alone or with pembrolizumab in people with solid tumors. The people in this study have a solid tumor that keeps growing after treatment and has spread. This study includes people with:

  • Squamous non-small cell lung cancer (NSCLC)
  • Head and neck squamous cell carcinoma (HNSCC)
  • Esophageal squamous cell carcinoma (ESCC)

EVM14 is a type of mRNA cancer vaccine. It helps your body make proteins called cancer antigens, which are found in cancer cells. When your body sees these antigens, it learns to recognize and attack cancer cells. EVM14 is given as an injection.

Pembrolizumab is an immunotherapy drug. It takes the brakes off the immune response so your immune system can find and kill cancer cells. Pembrolizumab is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have advanced squamous NSCLC, HNSCC, or ESCC that keeps growing after at least 2 regimens of prior treatment.
  • Have recovered from the serious side effects of previous treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call 646-888-4226.

Protocol

25-305

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07095868