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TG4010 and Nivolumab in Patients With Lung Cancer

Stage IV Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • 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
Clinical Trial Details
NCT number NCT02823990
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 2
Start date December 14, 2016
Completion date February 24, 2021
View Details
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