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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Advaxis, Inc.
- Enrollment
- 13
- Locations
- 10
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: From the first dose up to 20 months
Maximum tolerated dose
Time Frame: 4 weeks
Secondary Outcomes
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Baseline to measured progressive disease or start of new anticancer therapy (approximately 15 months))
- ORR According to immune Response Evaluation Criteria in Solid Tumors (iRECIST)(Baseline to measured progressive disease or start of new anticancer therapy (approximately 15 months))
- Disease Control Rate (DCR) According to RECIST v1.1(Baseline to measured progressive disease or death due to any cause (approximately 15 months))
- DOR According to iRECIST(Baseline to measured progressive disease or death due to any cause (approximately 15 months))
- Progression Free Survival (PFS) According to RECIST v1.1(Baseline to measured progressive disease or death due to any cause (approximately 15 months))
- Overall Survival(Baseline to death due to any cause (approximately 20 months))
- Duration of Response (DoR) According to RECIST v1.1(Baseline to measured progressive disease or death due to any cause (approximately 15 months))
- DCR According to iRECIST(Baseline to measured progressive disease or death due to any cause (approximately 15 months))
- PFS According to iRECIST(Baseline to measured progressive disease or death due to any cause (approximately 15 months))