Spots Global Cancer Trial Database for TG4010 and Nivolumab in Patients With Lung Cancer
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Trial Identification
Brief Title: TG4010 and Nivolumab in Patients With Lung Cancer
Official Title: Phase II Trial of TG4010 Plus Nivolumab in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT02823990
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California San Diego, San Diego, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Contact Details
Name: Karen Kelly
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR
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