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

NCT02531854 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: GBP-11-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of study participants with objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)

  2 years

• Number of study participants with progression free survival as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)

  2 years

Secondary Outcomes (5)

• Distribution of overall response rate (ORR) as assessed by RECIST v1.1 and irRECIST

  2 years

• Distribution of duration of response (DR) as assessed by RECIST v1.1 and irRECIST

  2 years

• Distribution of disease stabilization (SD) as assessed by RECIST v1.1 and irRECIST

  2 years

• Distribution of overall survival (OS) as assessed by RECIST v1.1 and irRECIST

  2 years

• Frequency and severity of treatment related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 for study participants on the combination arm

  2 years

Study Arms (2)

ADXS11-001 + Pemetrexed

EXPERIMENTAL

Drug: ADXS11-001; Drug: Pemetrexed

Pemetrexed Only

ACTIVE COMPARATOR

Drug: Pemetrexed

Interventions

ADXS11-001 DRUG

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.

ADXS11-001 + Pemetrexed

Pemetrexed DRUG

Chemotherapy

ADXS11-001 + Pemetrexed; Pemetrexed Only

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, ≥ 20 years of age
• Patients with NSCLC
• Patients whose disease has either responded or not progressed following 4-6 cycles of first-line induction chemotherapy.
• Patients with documented/confirmed intra-tumor positivity for HPV
• Patients with no major existing co-morbidities or medical conditions that will preclude administration of therapy, in the opinion of the Investigator
• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Patients will use contraception during the study
• Patients with the ability to understand and give written informed consent for participation in this trial

You may not qualify if:

• Women who are pregnant or breast feeding
• Patients with histologically- or cytologically-confirmed squamous cell-classified NSCLC
• Patients with disease progression following first-line induction chemotherapy
• Patients with known active and uncontrolled central nervous system (CNS) or leptomeningeal metastases
• Patients with an active second primary malignancy or history of another malignancy
• Patients with inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy, including ≥ Grade 2 neuropathy
• Patients with inadequate recovery from any previous surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the start of study treatment
• Patients with evidence of inadequate organ function as defined in protocol
• Patients with a known allergy to both of the following antibiotics: ampicillin, trimethoprim-sulfamethoxazole
• Patients with a known allergy to anti-emetic medications and/or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib)
• Patients with a history of severe hypersensitivity reaction to pemetrexed disodium (Alimta® or equivalent), or any of the excipients used in its formulation
• Patients with a history of an autoimmune disorder requiring systemic treatment within the past 3 months, or a documented history of a clinically severe autoimmune disease or a syndrome that requires systemic steroid or immunosuppressive agents
• Patients with a known immunodeficiency including patients: with HIV infection, who have undergone previous organ transplantation and require immunosuppressive therapy or long-term immunosuppressive therapy for any other reason
• Patients with interstitial lung disease or active, non-infectious pneumonitis, active or prior documented inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
• Patients with an active infection requiring systemic therapy, prior to dosing with study drug

Sponsors & Collaborators

• Advaxis, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: August 25, 2015
• Study Start: December 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 19, 2023

Record last verified: 2023-12