Clinical Trials /

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

Description:

- 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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GBP-11-201
  • NCT ID: NCT02531854

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
ADXS11-001ADXS11-001 + Pemetrexed
PemetrexedADXS11-001 + Pemetrexed

Purpose

- 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

Trial Arms

NameTypeDescriptionInterventions
ADXS11-001 + PemetrexedExperimental
  • ADXS11-001
  • Pemetrexed
Pemetrexed OnlyActive Comparator
  • Pemetrexed

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female patients, ≥ 20 years of age

          2. Patients with NSCLC

          3. Patients whose disease has either responded or not progressed following 4-6 cycles of
             first-line induction chemotherapy.

          4. Patients with documented/confirmed intra-tumor positivity for HPV

          5. Patients with no major existing co-morbidities or medical conditions that will
             preclude administration of therapy, in the opinion of the Investigator

          6. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

          7. Patients will use contraception during the study

          8. Patients with the ability to understand and give written informed consent for
             participation in this trial

        Exclusion Criteria:

          1. Women who are pregnant or breast feeding

          2. Patients with histologically- or cytologically-confirmed squamous cell-classified
             NSCLC

          3. Patients with disease progression following first-line induction chemotherapy

          4. Patients with known active and uncontrolled central nervous system (CNS) or
             leptomeningeal metastases

          5. Patients with an active second primary malignancy or history of another malignancy

          6. Patients with inadequate recovery from an acute toxicity associated with any prior
             antineoplastic therapy, including ≥ Grade 2 neuropathy

          7. 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

          8. Patients with evidence of inadequate organ function as defined in protocol

          9. Patients with a known allergy to both of the following antibiotics: ampicillin,
             trimethoprim-sulfamethoxazole

         10. Patients with a known allergy to anti-emetic medications and/or non-steroidal
             anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib)

         11. Patients with a history of severe hypersensitivity reaction to pemetrexed disodium
             (Alimta® or equivalent), or any of the excipients used in its formulation

         12. 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

         13. 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

         14. Patients with interstitial lung disease or active, non-infectious pneumonitis, active
             or prior documented inflammatory bowel diseases (e.g., Crohn's disease, ulcerative
             colitis)

         15. Patients with an active infection requiring systemic therapy, prior to dosing with
             study drug

         16. Patients with any other life-threatening illness, uncontrolled medical condition
             (e.g., elevated troponin or creatinine; uncontrolled diabetes), significant organ
             system dysfunction, or clinically significant laboratory abnormality, which in the
             opinion of the Investigator would either compromise the patient's safety or interfere
             with evaluation of the study treatment

         17. Patients with a psychiatric disorder, substance abuse disorder, or altered mental
             status that would preclude understanding of the informed consent process and/or
             completion of the necessary study-related evaluations

         18. Patients with a history of or current evidence of any condition, therapy, or
             laboratory abnormality that might: confound the results of the trial, interfere with
             the patient's participation in the trial, or suggest that participation in the trial
             is not in the best interest of the patient, in the opinion of the treating
             investigator
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Distribution of overall response rate (ORR) as assessed by RECIST v1.1 and irRECIST
Time Frame:2 years
Safety Issue:
Description:
Measure:Distribution of duration of response (DR) as assessed by RECIST v1.1 and irRECIST
Time Frame:2 years
Safety Issue:
Description:
Measure:Distribution of disease stabilization (SD) as assessed by RECIST v1.1 and irRECIST
Time Frame:2 years
Safety Issue:
Description:
Measure:Distribution of overall survival (OS) as assessed by RECIST v1.1 and irRECIST
Time Frame:2 years
Safety Issue:
Description:
Measure: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
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Advaxis, Inc.

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