NCT03265080

A Study of ADXS-NEO Expressing Personalized Tumor Antigens

A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens, Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Advaxis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in participants with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).

Detailed description

Mutation-derived tumor antigens, which are often unique to each participant'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 participant's T cells. The lack of expression of participant-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 participant-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 participant-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-programmed cell death protein-1 (PD-1) inhibitors.

Conditions

• Colon Cancer Metastatic
• Head and Neck Cancer Metastatic
• Metastatic Non-Small Cell Lung Cancer
• Urothelial Carcinoma
• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ADXS-NEO	Intravenous infusion
BIOLOGICAL	Pembrolizumab	Intravenous infusion

Timeline

• Start date: 2018-03-28
• Primary completion: 2019-10-24
• Completion: 2020-11-12
• First posted: 2017-08-29
• Last updated: 2023-02-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study