Hear the personal stories of men and women who have fought cancer with axalimogene filolisbac in clinical trials. A Phase 1/2, Open-Label Study of ADXS-503 Alone and in Combination with Pembrolizumab in Subjects with Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer. CLINICAL TRIALS . Stay up to date on the latest events, news, and happenings on Advaxis and Immunotherapy. STAY TUNED Sign up for email alerts for Press Releases and Advaxis' breaking news. Enroll subjects with metastatic squamous or non-squamous NSCLC who have become refractory or intolerant to standard therapy. Advaxis’ lead Lm Technology™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for … As well, to characterize the preliminary anti-tumor activity of ADXS-503, administered in combination with pembrolizumab in Part C, per RECIST v1.1.A live attenuated Listeria monocytogenes (Lm)-based immunotherapy bioengineered to elicit T cell responses against shared tumor antigens commonly found in patients with squamous and non-squamous NSCLC.A live attenuated Listeria monocytogenes (Lm)-based immunotherapy bioengineered to elicit T cell responses against shared tumor antigens commonly found in patients with squamous and non-squamous NSCLC.a programmed death receptor-1 (PD-1)- blocking antibody.A live attenuated Listeria monocytogenes (Lm)-based immunotherapy bioengineered to elicit T cell responses against shared tumor antigens commonly found in patients with squamous and non-squamous NSCLC.a programmed death receptor-1 (PD-1)- blocking antibody.Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03 Subjects who have received >3 lines of prior therapy may be eligible for Part A, upon discussion with and approval by the Sponsor.A female subject is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least one of the following conditions applies:Subject has had major surgery within 6 weeks prior to the initiation of study treatment. ADXS-503 will be evaluated at 2 planned escalating dose levels in combination with a fixed dose of pembrolizumab:Enroll subjects with metastatic squamous or non-squamous NSCLC.1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.Pre-and on-treatment blood samples evaluate the changes in the states of activation and differentiation in various immune cells by flow cytometry and profiling of gene expression.Evaluate changes in serum levels of cytokines, chemokines and other analytes by multiplex assays and mass spectrometry.Evaluate changes in the peripheral T cell repertoire by immunosequencing.Evaluate the frequency of functional tumor antigen-specific T cells by ELISpot analysis.Subject has histologically or cytologically confirmed stage IV (metastatic) squamous or non-squamous NSCLC▪ Subject has received, and then progressed or been intolerant to up to 3 lines of prior therapy in the metastatic setting, including approved chemotherapy, targeted therapy, immunotherapy and antibody therapy, if eligible. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. Advaxis has five immunotherapy candidates currently in late stage development, targeting a range of types of cancers. COVID-19 is an emerging, rapidly evolving situation. focused on the development and commercialization of proprietary Lm-based antigen delivery products. Sponsor must be consulted prior to enrolling subjects on the study who recently had a major surgery or have a new artificial implant, and/or devices;Subject is or has an immediate family member (spouse or children) who, as investigational site or sponsor staff, is directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject;In Part C, subject has received systemic therapy for the treatment of their metastatic NSCLC.Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease;
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