NCT03847519

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Advaxis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-12
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2019-02-20
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study