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NCT02460367 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02460367 is a Phase 1 study that was terminated before completion, run by NewLink Genetics Corporation. The registered enrollment target is 16 participants.
The verdict
NCT02460367, a Phase 1 study, was terminated before completion, sponsored by NewLink Genetics Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Interventions
- DRUG Docetaxel
- DRUG Indoximod
- BIOLOGICAL Tergenpumatucel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-01 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02460367
The ClinicalTrials.gov registry entry for NCT02460367 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT02460367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02460367 about?
NCT02460367 is a clinical study titled "Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer". 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 successfu...
What is the current status of trial NCT02460367?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-01. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT02460367?
The interventions under investigation include: Docetaxel (DRUG), Indoximod (DRUG), Tergenpumatucel-L (BIOLOGICAL).
Who is sponsoring clinical trial NCT02460367?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
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