A Phase I Study of Viral Vaccine Therapy and Atezolizumab Immunotherapy in Patients with Recurrent and Metastatic HPV-Associated Cancers

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Full Title

A Phase 1/1b, Multicenter, Open-label Trial of Oncolytic MG1 Expressing Mutant Human Papilloma Virus (HPV) E6 and E7 (MG1-E6E7), with Adenovirus Vaccine Expressing Mutant HPV E6 and E7 (Ad-E6E7) and Atezolizumab in Patients with HPV Associated Cancers

Purpose

The purpose of this study is to find the highest dose of an investigational cancer vaccine that can be given safely in patients with cancers caused by the human papillomavirus (HPV) that have come back or metastasized. The vaccine consists of two different viruses (Ad-E6E7 and MG1-E6E7) and will be given alone or in combination with atezolizumab immunotherapy.

Ad-E6E7 is made from a common cold virus which was engineered to carry E6E7 proteins found in the HPV virus. These proteins can cause some cancers, but they can also be targeted by the immune system to kill cancer cells. Almost all cervical cancers are caused by HPV, as well as cancers of the head and neck and vulvar, penile, anal, and vaginal cancers. The Ad-E6E7 vaccine has been modified so that the immune system responds to it by reacting against the HPV-E6E7 proteins. This effect is called “priming” the immune system.

MG1-E6E7 is made from a different virus, which was also engineered to carry HPV-E6E7 viral proteins. The virus has been altered so that it can penetrate tumor cells, reproduce inside them, and kill them. Laboratory studies have shown that MG1-E6E7 strengthens the immune system’s response against tumor cells after Ad-E6E7 has been given. This effect is called “boosting” the immune system.

Atezolizumab strengthens the immune system’s ability to attack tumor cells. It is thought to be most effective when an anticancer immune response has already begun, similar to the immune response triggered by Ad-E6E7 plus MG1-E6E7. Atezolizumab is used to treat advanced lung cancer and bladder cancer; its use in this study is investigational. Ad-E6E7, MG1-E6E7, and atezolizumab are given intravenously (by vein). Some patients will also have MG1-E6E7 injected directly into their tumors.

Eligibility

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

  • Patients must have recurrent or metastatic cervical, oropharynx, vulvar, vaginal, anal, or penile cancer that is positive for HPV.
  • At least 4 weeks must pass between the completion of prior treatment 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. Dmitriy Zamarin at 646-888-4593.

Protocol

18-444

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators