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

Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Recurrent; Progression of Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Biological: Tergenpumatucel-L; Drug: Indoximod

• Registration Number: NCT02460367
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Study Start: 2016-01
• Primary Completion: 2017-07-17
• Study Completion: 2021-01-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: Dose Escalation	Indoximod	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.
Phase 1: Dose Escalation	Tergenpumatucel-L	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.
Phase 1: Dose Escalation	Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
Regimen Limiting Toxicity	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)	Approximately 18 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Approximately 30 months
Response rate to subsequent therapy	up to 36 months	Assess evidence of delayed response of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.
Frequency and grade of adverse events of tergenpumatuucel-L, indoximod and docetaxel	Approximately 18 months
Objective Response Rate	Approximately 18 months	To assess preliminary evidence of efficacy of tergenpumatuucel-L, indoximod and docetaxel using RECIST 1.1 measurement criteria.

Trial Locations

Locations (2)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States