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Carcinoma, Non-Small-Cell LungPhase 2NCT02531854

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 study testing ADXS11-001 and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Advaxis, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
ADXS11-001 and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2018to Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • 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
  • 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
  • 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

About this study

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

  • 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
Being tested
ADXS11-001, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADXS11-001Drug

    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.

  • PemetrexedDrug

    Chemotherapy

Study groups in NCT02531854
Study groupRoleWhat they receive
ADXS11-001 + PemetrexedExperimentalNot described
Receives: Drug: ADXS11-001; Drug: Pemetrexed
Pemetrexed OnlyActive comparatorNot described
Receives: Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 years

  2. 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)

    Measured: 2 years

Secondary outcomes (5)

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  5. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2015 (estimated)
  2. Study startDec 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Why it stopped: Study was withdrawn per sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531854
Sponsor's protocol ID
GBP-11-201
Status last verified
Dec 2023
First submitted
26 Feb 2015
Last updated
19 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADXS11-001 and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Advaxis, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.

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