You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.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 CancerTo evaluate the safety and tolerability of ADXS-503, administered as monotherapy in Part A and in combination with pembrolizumab in Part B, and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD). Sign up for email alerts for Press Releases and Advaxis' breaking news. 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. Hear the personal stories of men and women who have fought cancer with axalimogene filolisbac in clinical trials. Advaxis has a broad clinical pipeline maximizing the potential of Lm Technology™ in three separate areas of focus: CLINICAL THERAPIES . Protocol ADXS-503-101, Advaxis Inc, 2018. focused on the development and commercialization of proprietary Lm-based antigen delivery products. Advaxis Details Registrational Trials, EU Regulatory and Commercial Plans at Annual Investor & Analyst Day - Advaxis, Inc. (MM) ADXS 16/06/2020 13:15:57 1-888-992-3836 Free Membership Login Monitor Advaxis’ lead Lm Technology™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for … Advaxis, Inc. ClinicalTrials.gov Identifier: NCT03265080 Other Study ID Numbers: ADXS-NEO-02 : First Posted: August 29, 2017 Key Record Dates: Last Update Posted: January 13, 2020 Last Verified: March 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No 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.
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
COVID-19 is an emerging, rapidly evolving situation. Stay up to date on the latest events, news, and happenings on Advaxis and Immunotherapy. ADXS-503 monotherapy will be evaluated at 2 planned escalating dose levels:Enroll subjects with metastatic squamous or non-squamous NSCLC.
Enroll subjects with metastatic squamous or non-squamous NSCLC who have become refractory or intolerant to standard therapy. Enroll subjects with metastatic squamous or non-squamous NSCLC who have become refractory or intolerant to standard therapy. Advaxis has five immunotherapy candidates currently in late stage development, targeting a range of types of cancers. Advaxis Lm Technology™ in Action . 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. Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. STAY TUNED CLINICAL TRIALS . These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. Advaxis is a clinical-stage biotechnology company. Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases.
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