NCT02823990

TG4010 and Nivolumab in Patients With Lung Cancer

Phase II Trial of TG4010 Plus Nivolumab in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Megan Daly, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well TG4010 and nivolumab work in previously treated patients with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread. Giving TG4010 and nivolumab together may work better in previously treated patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: To evaluate the efficacy of nivolumab plus TG4010 (modified vaccinia virus Ankara \[MVA\]-human mucin 1 \[MUC1\]-interleukin-2 \[IL2\] vaccine) in previously treated patients with stage IV non squamous non-small cell lung cancer (NSCLC) with respect to objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. SECONDARY OBJECTIVES: Define the safety and toxicity profile of nivolumab plus TG4010 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4. Determine progression-free survival by RECIST 1.1. Determine overall survival. Determine the duration of response and the occurrence of responses over time. Determine the rate and duration of stable disease. Determine the disease control rate.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage I Non-Small Cell Lung Cancer
• Stage II Non-Small Cell Lung Cancer
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TG4010	Given SC
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2016-12-14
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2016-07-06
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

4 sites across 1 country: United States