Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Immunomodulating Agents

Immunoglobulins

Antibodies, Blocking

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enroll subjects with metastatic squamous or non-squamous NSCLC who have become refractory or intolerant to standard therapy. ADXS-503 monotherapy will be evaluated at 2 planned escalating dose levels:

* Dose level 1: 1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
* Dose level 2: 5e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.

Enroll subjects with metastatic squamous or non-squamous NSCLC. ADXS-503 will be evaluated at 2 planned escalating dose levels in combination with a fixed dose of pembrolizumab:

* Dose level 1: 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.
* Dose level 2: 5e8 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.

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.

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.

ADXS-503

a programmed death receptor-1 (PD-1)- blocking antibody.

Surya Vangala

Edwin Smura

Ranjan Pathak, MD

Joanna Gutierrez

Jonathan Goldman

Roy Daneker

Suresh Ramalingam

Ashton Todd

Gregory Gerstner

Travis Martin

Kathan Mehta, MD

Christopher Buck

Missak Haigentz

Charlotte Sklow

Balazs Halmos, MD

Brenda Fisher

Rachel Sanborn, MD

Anthony Jones

Alexander Spira, MD

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

To 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). As well, to characterize the preliminary anti-tumor activity of ADXS-503, administered in combination with pembrolizumab in Part C, per RECIST v1.1.

Safety phase:

* Part A: ADXS-503 monotherapy dose escalation
* Part B: ADXS-503 + pembrolizumab dose escalation

Efficacy phase:

• Part C: ADXS-503 + pembrolizumab

Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer

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

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.

Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03

Advaxis, Inc.

Spots Global Cancer Trial Database for Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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