NCT02531854

A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus Positive (HPV+), NSCLC Following First-Line Induction Chemotherapy

A Phase 2, Open-label, Randomized, Parallel Group, Controlled Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus-Positive, Non-Squamous, Non-Small Cell Lung Carcinoma Following First-Line Induction Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Advaxis, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

* Open label * Enrollment in the order of confirmation of eligibility and HPV+ tumor status * Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome; * Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone) * Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy * Control Arm: Pemetrexed only * Positive control: pemetrexed chemotherapy

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	ADXS11-001	ADXS11-001 is a live attenuated Listeria monocytogenes (Lm) bacteria bioengineered to secrete an antigen-adjuvant fusion protein (tLLO¬HPV-E7) consisting of a truncated fragment of the listeriolysin O (tLLO) fused to the full length E7 peptide of HPV-16.
DRUG	Pemetrexed	Chemotherapy

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2015-08-25
• Last updated: 2023-12-19

Regulatory

• FDA-regulated drug study