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Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02460367
Recruitment Status : Unknown
Verified February 2016 by NewLink Genetics Corporation.
Recruitment status was:  Recruiting
First Posted : June 2, 2015
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Brief Summary:

This is a Phase 1/2 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a practical standpoint, a successful tumor immunotherapy will likely require a combination treatment with additional therapeutic interventions that both activate an immune response and remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune system to recognize the abnormal components found in lung cancer cells, resulting in an immune response intended to destroy or block the growth of the cancer; and the second, the IDO inhibitor Indoximod, will overcome tumor-induced immune suppression.

The goal of this study is to assess the progression-free survival (PFS) and overall survival (OS) rates in this patient population. This study will provide a foundation for future trials testing indoximod combined with tergenpumatucel-L.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Progression of Non-small Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Drug: Docetaxel Biological: Tergenpumatucel-L Drug: Indoximod 600mg Drug: Indoximod 1200mg Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Tergenpumatucel-L (HyperAcute Lung) Immunotherapy in Combination With the IDO Pathway Inhibitor Indoximod and Docetaxel in Patients With Advanced Previously Treated Non-Small Cell Lung Cancer (NSCLS)
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Dose Level 1

Tergenpumatucel-L given every 3 weeks for up to a total of 18 immunizations

Indoximod given TID every day until disease progression or significant toxicity.

Docetaxel given every 3 weeks until disease progression or significant toxicity.

Drug: Docetaxel
Docetaxel given as an IV infusion over one hour at a dose of 75mg/m2 given every three weeks (on Day 1 of each cycle ) until disease progression or significant toxicity.
Other Name: Taxotere®

Biological: Tergenpumatucel-L
HAL-1, HAL-2 and HAL-3 immunotherapy components. 300M cells administered as an intradermal injection given every 3 weeks for up to a total of 18 doses.
Other Name: HyperAcute®-Lung Immunotherapy

Drug: Indoximod 600mg
600mg by mouth three times a day everyday until disease progression or significant toxicity.

Experimental: Dose Level 2

Tergenpumatucel-L given every 3 weeks for up to a total of 18 immunizations

Indoximod given TID every day until disease progression or significant toxicity.

Docetaxel given every 3 weeks until disease progression or significant toxicity.

Drug: Docetaxel
Docetaxel given as an IV infusion over one hour at a dose of 75mg/m2 given every three weeks (on Day 1 of each cycle ) until disease progression or significant toxicity.
Other Name: Taxotere®

Biological: Tergenpumatucel-L
HAL-1, HAL-2 and HAL-3 immunotherapy components. 300M cells administered as an intradermal injection given every 3 weeks for up to a total of 18 doses.
Other Name: HyperAcute®-Lung Immunotherapy

Drug: Indoximod 1200mg
1200mg by mouth three times a day everyday until disease progression or significant toxicity.




Primary Outcome Measures :
  1. Regimen Limiting Toxicity [ Time Frame: Approximately 6 weeks ]
    Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of tergenpumatucel-L and indoximod.

  2. Progression Free Survival (PFS) [ Time Frame: Approximately 18 months ]

Secondary Outcome Measures :
  1. Frequency and grade of adverse events of tergenpumatuucel-L, indoximod and docetaxel [ Time Frame: Approximately 18 months ]
  2. Objective Response Rate [ Time Frame: Approximately 18 months ]
    To assess preliminary evidence of efficacy of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.

  3. Overall Survival [ Time Frame: Approximately 30 months ]
  4. Response rate to subsequent therapy [ Time Frame: up to 36 months ]
    Assess evidence of delayed response of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.



Information from the National Library of Medicine

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

Inclusion Criteria

  • Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed histologies of NSCLC (i.e., adenosquamous) are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are NOT eligible for this study.
  • Measurable disease as defined by RECIST 1.1 Criteria.
  • At least one but no more than three prior lines of therapy in the advanced stage are allowed. One prior line of therapy must be platinum doublet chemotherapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 1
  • Normal bone marrow and organ function as defined below:

    • Marrow: Hemoglobin ≥10.0 gm/dL, absolute granulocyte count (AGC) ≥1,000/mm3 platelets ≥100,000/mm3, absolute lymphocyte count ≥1000/mm3.
    • Hepatic: Serum/plasma total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ≤2.5 x ULN.
    • Renal: Serum/plasma creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥50 mL/min.
  • Serum/plasma albumin > 3.0 gm/dL
  • Sexually active women of child-bearing potential must agree to use two forms of contraception prior to study entry and for the duration of study participation. A pregnancy test is required prior to study enrollment and monthly while on treatment with indoximod for all women of child- bearing potential. Also men should be discouraged from fathering children while on treatment.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

  • More than three lines of prior therapy.
  • Previous use of indoximod or tergenpumatucel-L immunotherapy.
  • A history of other malignancy, unless treated with curative intent, and no evidence of disease for at least 2 years.
  • Current therapy with any other investigational agents.
  • Untreated CNS disease, metastases or carcinomatous meningitis. Patients with CNS metastases must be at least 2 weeks status post prior therapy to the brain and be off all steroids without progressing CNS disease or symptoms.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to indoximod, docetaxel, or other agents used in the study.
  • Current use of immunosuppressive drugs or use of corticosteroids, except for inhaler, topical corticosteroids, or dexamethasone in the premedication for docetaxel.
  • Other malignancy within three years, unless the probability of recurrence of the prior malignancy is <5%. Patient's curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
  • History of organ transplant.
  • Any of the following within 6 months prior to study drug administration:

    • Myocardial infarction
    • Severe/unstable angina
    • Coronary/peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled ongoing cardiac dysrhythmias of ≥ grade 2, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity on combination antiretroviral therapy because of the unknown potential for pharmacokinetic interactions with indoximod, or docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy.
  • Active autoimmune disease requiring systemic therapy. Patients with a history of autoimmune disease must be counselled regarding the unknown potential of exacerbating or reactivating previous or dormant autoimmunity during the consent process.

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 ClinicalTrials.gov identifier (NCT number): NCT02460367


Contacts
Contact: Christopher Smith, MS 515-598-2935 csmith@linkp.com

Locations
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Molly Karl    314-747-7417    MKARL@DOM.wustl.edu   
Principal Investigator: Daniel Morgensztern, MD         
Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
Study Director: Gene Kennedy, MD NewLink Genetics Corporation

Additional Information:
Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT02460367     History of Changes
Other Study ID Numbers: NLG0401
1504-1393 ( Other Identifier: Office of Biotechnology Activities )
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NewLink Genetics Corporation:
Non-small Cell Lung Cancer
Vaccine Therapy
Immunotherapy
Second line therapy
Progressive
Relapsed
IDO
IDO Inhibitor

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Docetaxel
Tryptophan
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs