Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02460367|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : May 21, 2019
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||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 17, 2017|
|Estimated Study Completion Date :||August 1, 2032|
Experimental: Phase 1: Dose Escalation
Up to 18 participants will be enrolled and treated at escalating doses of Indoximod with a fixed dose of tergenpumatucel-L and docetaxel. Treatment may continue until definitive disease progression or significant toxicology.
Other Name: Taxotere®
Other Name: HyperAcute®-Lung Immunotherapy
- 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.
- Progression Free Survival (PFS) [ Time Frame: Approximately 18 months ]
- Frequency and grade of adverse events of tergenpumatuucel-L, indoximod and docetaxel [ Time Frame: Approximately 18 months ]
- 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.
- Overall Survival [ Time Frame: Approximately 30 months ]
- 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.
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
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45219|
|Study Director:||Gene Kennedy, MD||NewLink Genetics Corporation|