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

NCT03847519 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-06-04

Study results available
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Summary

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

Conditions

  • Lung Cancer, Non-Small Cell
  • Metastatic Squamous Cell Carcinoma
  • Metastatic Non-Squamous Cell Carcinoma

Interventions

DRUG

ADXS-503

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.

DRUG

Pembrolizumab

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

Sponsors & Collaborators

  • Advaxis, Inc.

    lead INDUSTRY

Principal Investigators

  • Surya Vangala · Senior Director, Clinical Operations, Advaxis Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2022-02-22
Completion
2022-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847519 on ClinicalTrials.gov