NCT04024878

NeoVax With Nivolumab in Patients With Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a new type of vaccine called "Personalized NeoAntigen Cancer Vaccine" in combination with Nivolumab (Opdivo®) for ovarian cancer.

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational Personalized Cancer Vaccine in combination with Nivolumab (Opdivo®). "Investigational" means that the Personalized Cancer Vaccine is being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved the Personalized Cancer Vaccine as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved Nivolumab for this specific disease but it has been approved for other uses. The purpose of this study is to determine if it is possible to make and administer safely a vaccine against ovarian cancer by using information gained from specific characteristics of the participant's own ovarian cancer. It is known that ovarian cancers have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the body fight tumor ovarian cancer cells. The study will examine the safety of the vaccine when given at several different time points and will examine the blood cells for signs that the vaccine induced an immune response. Ovarian cancer cells will be obtained from the tumor through a biopsy. The genetic material contained in the ovarian cancer cells will be examined for the presence of tumor-specific mutations. This information will be used to prepare small protein fragments, which are called "peptides". The vaccine will consist of up to 20 of these peptides as well as a drug that activates the immune system called Poly-ICLC. Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC binds proteins on the surface of certain immune cells to make it appear as if a virus is present. When the cells detect the vaccine, they think it is a virus and turn on the immune system. Poly-ICLC is a compound that has been used to help the body in its fight against cancer. Poly-ICLC will be mixed with NeoAntigen peptides and administered as an injection given underneath the skin. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease. Nivolumab (Opdivo®) is an antibody that has been approved by the United States Food and Drug Administration (FDA) for the treatment of metastasic lung cancer, metastasic melanoma, advanced renal cell carcinoma, recurrent or metastasic carcinoma of the neck, hepatocellular carcinoma, advanced or metastasic urothelial carcinoma, metastasic colorectal cancer, and relapsed or progressed Hodgkin Lymphoma. An antibody is a common type of protein produced by your body that the immune system (a system that defends the body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in the body) such as bacteria and viruses. Antibodies can also be produced in the laboratory for use in treating patients. There are now several approved antibodies for the therapy of cancer and other diseases. Nivolumab is an antibody that acts against PD-1. PD-1 is a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could also be by blocking it out so. An antibody against PD-1 can stop PD-1 from turning off the immune system, allowing the immune reaction to continue. The body's immune reaction may help the body to destroy cancer cells.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab (Opdivo®) is an antibody. An antibody is a common type of protein produced by the body that the immune system uses to find and destroy foreign molecules.
BIOLOGICAL	NeoVax	The vaccine will consist of up to 20 peptides as well as a drug that activates the immune system called Poly-ICLC. Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity
PROCEDURE	Core Needle Biopsy	Surgical procedure

Timeline

• Start date: 2020-11-20
• Primary completion: 2025-04-30
• Completion: 2029-04-30
• First posted: 2019-07-18
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study