Trials / Terminated
TerminatedNCT02460367
Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer
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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- NewLink Genetics Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non-small Cell Lung Cancer
- Progression of Non-small Cell Lung Cancer
- Non-small Cell Lung Cancer Recurrent
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | |
| BIOLOGICAL | Tergenpumatucel-L | |
| DRUG | Indoximod |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-07-17
- Completion
- 2021-01-13
- First posted
- 2015-06-02
- Last updated
- 2022-04-06
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02460367. Inclusion in this directory is not an endorsement.