A Phase I Study of the CVA21 Virus plus Pembrolizumab Immunotherapy in Patients with Advanced Non-Small Cell Lung Cancer or Bladder Cancer

Full Title

A Phase 1, Dose-Finding and Signal-Seeking Study of the Safety and Efficacy of Intravenous CAVATAKTM (Coxsackievirus A21, CVA21) Alone and in Combination with Pembrolizumab in Patients with Late Stage Solid Tumours (NSCLC, Castrate-Resistant Prostate Cancer, Melanoma and Bladder Cancer)

Purpose

CVA21 (CAVATAK) is a naturally occurring virus that causes the common cold. It has also been shown to selectively infect some types of cancer cells without harming normal cells. This cancer cell infection may prime the immune system to attack the cancer. Researchers are interested in knowing if combining CVA21 with an immunotherapy drug like pembrolizumab can further enhance the immune response against cancer cells. In this study, they are evaluating three different doses of CVA21 in combination with pembrolizumab in patients with advanced non-small cell lung cancer or bladder cancer.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat melanoma and non-small cell lung cancer, and has shown activity against bladder cancer. Its use together with CVA21 in this study is considered investigational. Both pembrolizumab and CVA21 are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must have advanced non-small cell lung cancer or bladder cancer that has continued to grow despite prior treatment.
  • At least 3 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Charles Rudin at 646-888-4336.

Protocol

16-942

Phase

I

Investigator

Co-Investigators

Locations