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Expressing Personalized Tumor Antigens Study (NEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03265080
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Advaxis, Inc.

Brief Summary:
This is a phase 1, open-label, uncontrolled, multicenter study in 3 distinct solid tumors. The study design is dose-escalation/de-escalation using a standard 3 + 3 design to evaluate the safety profile of ADXS-NEO, to select a recommended phase 2 dose (RP2D), and identify initial signs of clinical activity in each of the 3 tumor-specific cohorts.

Condition or disease Intervention/treatment Phase
Colon Cancer Metastatic Head and Neck Cancer Metastatic Metastatic Non-Small Cell Lung Cancer Biological: ADXS-NEO Phase 1

Detailed Description:
Mutation-derived tumor antigens, which are often unique to each patient's tumor, represent a new source of targets for cancer immunotherapy. These mutations, which arise during tumorigenesis, are expressed only by the tumor and, as such, may be recognized as newly formed antigens, or neoantigens, by the patient's T cells. The lack of expression of patient-specific tumor mutations in nonmalignant cells suggests that vaccines targeting these tumor mutations have a low risk of autoimmunity and may represent a safer therapeutic approach than many of those currently available. The development of a Listeria monocytogenes (Lm)-based vaccine that expresses these patient-specific tumor antigens and that activates tumor-killing T cells has the potential to be a highly effective form of immunotherapy. In addition, the Lm platform, because it mediates tumor control through multiple mechanisms, may exhibit more robust anti-tumor activity than other vaccine platforms. Thus, the targeting of patient-specific mutation-derived tumor antigens and the concurrent stimulation of host immunity provides a rational approach for boosting anti-tumor immunity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Personalized immunotherapy treatment design
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of Advaxis (ADXS) NEO Expressing Personalized Tumor Antigens in Subjects With Metastatic Microsatellite Stable Colon Cancer, Metastatic Squamous Histology Head and Neck Cancer, and Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose Group 1

Dose cohorts of 3 participants each will be treated. Initiation of dosing will be staggered by at least 4 weeks for participants in the first cohort, also known as intra-cohort staggering.

The first cohort will receive a dose of ADXS-NEO 1 x 10 to the 9th power colony forming unit (CFU) (DL1).

Biological: ADXS-NEO
Biopsy, blood draws, CT scans, trial product administration

Experimental: Dose Group 2
The second cohort group will receive a dose of ADXS-NEO 2 x 10 to the 9th power CFU (DL2).
Biological: ADXS-NEO
Biopsy, blood draws, CT scans, trial product administration

Experimental: Dose Group 3
The third cohort group will receive a dose of ADXS-NEO 4 x 10 to the 9th power CFU (DL3).
Biological: ADXS-NEO
Biopsy, blood draws, CT scans, trial product administration

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 5 Years ]
    Evaluate the safety and tolerability of ADXS-NEO in metastatic colorectal cancer (CRC), metastatic SCCHN, and metastatic NSCLC through review of AEs and the incidence of their occurrence.

  2. Clinical Laboratory Values [ Time Frame: 5 years ]
    Clinical Laboratory Values including serum chemistry, complete blood count, urinalysis, pregnancy tests

  3. Vital Signs [ Time Frame: 5 years ]
    Vital Signs including but not limited to (degrees celsius, systolic, diastolic, beats per minute (BPM), breaths per minute (bpm)

  4. Maximum tolerated dose [ Time Frame: 5 years ]
    The highest dose tolerated in colony forming units (CFUs)

Secondary Outcome Measures :
  1. Initial signs of clinical activity [ Time Frame: 5 years ]
    Assess initial signs of clinical activity by monitoring DCR, tumor response, and PFS, using RECIST 1.1, and irRECIST and OS per site investigator's assessment. These measurements are in millimeters (mm)

  2. Disease Control Rate - DCR [ Time Frame: 5 years ]
    Rate of metastases of cancer measured in percentage

  3. Tumor Response [ Time Frame: 5 years ]
    Rate of metastases or shrinkage of tumor measured in percentage

  4. Progression Free Survival [ Time Frame: 5 years ]
    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. This is measured in percentage.

  5. Overall Survival [ Time Frame: 5 years ]
    The length of time from either the date of diagnosis or the start of treatment that diagnosed patients are still alive. This is also mentioned as a ratio in percentage.

Other Outcome Measures:
  1. Immunological markers [ Time Frame: 5 years ]
    Immunological markers (e.g., immune cell phenotype, pattern of in vivo cytokine/chemokine expression, frequency and function of vaccine- and tumor-specific T cells, and cellular and molecular changes in the tumor micro-environment from baseline)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Prior exposure to immunotherapy including, but not limited to, anti-PD1 or anti-PDL1 antibodies is allowed but not required.
  • Histological or cytological diagnosis of metastatic CRC excluding known microsatellite instable sub-types, metastatic SCCHN or metastatic NSCLC that have progressed or have become intolerant to standard therapy, and whose disease may allow management with other available therapies
  • Baseline tumor biopsy must be adequate
  • Has evaluable or measurable disease for response assessment
  • Females - not pregnant and willing to follow contraceptive guidance
  • Males - Willing to follow contraceptive guidance

Exclusion Criteria:

  • Is not expected to be available to receive study drug within 16 weeks from the time of baseline biopsy for any reason
  • Has a newly diagnosed tumor and a curative treatment option or approved therapy is available
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Any active autoimmune disease
  • Any other diseases that, in the opinion of the investigator and Sponsor's medical monitor would pose a risk to the subject safety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03265080

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Contact: Andres Gutierrez, MD 844-783-1529

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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Frank Tsai, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90404
Principal Investigator: Randy Hecht, MD         
Sponsors and Collaborators
Advaxis, Inc.

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Responsible Party: Advaxis, Inc. Identifier: NCT03265080     History of Changes
Other Study ID Numbers: ADXS-NEO-02
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Colonic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases