a study on Lung Cancer
This phase II trial studies how well TG4010 and nivolumab work in treating patients with non-small cell lung cancer that has gotten worse after one line of systemic therapy. Vaccines 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 treating patients with non-small cell lung cancer that has gotten worse after one line of systemic therapy.
Phase II Trial of TG4010 Plus Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed After One Line of Systemic Therapy
To evaluate the efficacy of nivolumab plus TG4010 (modified vaccinia virus Ankara [MVA]-human mucin 1 [MUC1]-interleukin-2 [IL2] vaccine) in patients with stage IV non squamous non-small cell lung cancer (NSCLC) who have progressed after one line of systemic therapy with respect to objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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.
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 Nivolumab Interleukin-2 Antibodies, Monoclonal
Open to people ages 18 years and up
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