Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
48

Summary

Conditions
  • Colon Cancer Metastatic
  • Head and Neck Cancer Metastatic
  • Metastatic Melanoma
  • Metastatic Non Small Cell Lung Cancer
  • Urothelial Carcinoma
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Personalized immunotherapy treatment designMasking: None (Open Label)Masking Description: Open labelPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Mutation-derived tumor antigens, which are often unique to each patient's tumor, represent a new source of targets for cancer immunotherapy. These mutations, which arise during tumorigenesis, are expressed only by the tumor and, as such, may be recognized as newly formed antigens, or neoantigens, by...

Mutation-derived tumor antigens, which are often unique to each patient's tumor, represent a new source of targets for cancer immunotherapy. These mutations, which arise during tumorigenesis, are expressed only by the tumor and, as such, may be recognized as newly formed antigens, or neoantigens, by the patient's T cells. The lack of expression of patient-specific tumor mutations in nonmalignant cells suggests that vaccines targeting these tumor mutations have a low risk of autoimmunity and may represent a safer therapeutic approach than many of those currently available. The development of a Listeria monocytogenes (Lm)-based vaccine that expresses these patient-specific tumor antigens and that activates tumor-killing T cells has the potential to be a highly effective form of immunotherapy. In addition, the Lm platform, because it mediates tumor control through multiple mechanisms, may exhibit more robust anti-tumor activity than other vaccine platforms. Thus, the targeting of patient-specific mutation-derived tumor antigens and the concurrent stimulation of host immunity provides a rational approach for boosting anti-tumor immunity, as monotherapy and in combination with anti-PD-1 inhibitors.

Tracking Information

NCT #
NCT03265080
Collaborators
Not Provided
Investigators
Not Provided