TG4010 and Nivolumab in Patients With Lung Cancer
|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||Biological: TG4010 Biological: Nivolumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of TG4010 Plus Nivolumab in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)|
- ORR defined as the proportion of patients whose best overall response (BOR) is either complete response (CR) or partial response (PR) according to RECIST 1.1 [ Time Frame: Up to 2 years ]Proportions of patients with a best overall response of CR or PR will be presented with exact 95% confidence intervals and p-value associated to the binomial test (with null proportion as reference). Will be performed on the Evaluable patient set. The analysis will be repeated on intent-to-treat (ITT) for confirmation.
- Disease control rate defined as the proportion of patients whose BOR is either CR, PR or SD, assessed by RECIST 1.1 [ Time Frame: Up to 2 years ]
- Duration of response (DOR) defined as patients whose best overall response is CR or PR (confirmed response) [ Time Frame: Time from the first documented response (CR or PR) until the event defined as first documented disease progression, assessed for up to 2 years ]
- Incidence of adverse events reported per CTCAE v4.0 [ Time Frame: Up to 100 days after last study treatment administration ]
- Overall survival (OS) defined by RECIST 1.1 [ Time Frame: Time from enrollment until death from any cause, assessed for up to 2 years ]
- Progression free survival (PFS) defined by RECIST 1.1 [ Time Frame: Time from enrollment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first, assessed for up to 2 years ]
- Stable disease (SD) rate defined as the proportion of patients whose BOR is SD, assessed by RECIST 1.1 [ Time Frame: Up to 2 years ]
|Study Start Date:||December 2016|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment TG4010 + nivolumab
Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Other Names:Biological: Nivolumab
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02823990
|United States, California|
|City of Hope Comprehensive Cancer Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Marianna Koczywas, M.D. 626-256-4673 email@example.com|
|Principal Investigator: Marianna Koczywas, M.D.|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Karen L. Kelly, M.D. 916-734-3735 firstname.lastname@example.org|
|Principal Investigator: Karen L. Kelly, M.D.|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Lyudmila Bazhenova, M.D. email@example.com|
|Principal Investigator: Lyudmila Bazhenova, M.D.|
|UCSF Medical Center-Mount Zion||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Matthew Gubens, M.D., M.S. Matthew.Gubens@ucsf.edu|
|Principal Investigator: Matthew Gubens, M.D., M.S.|
|Principal Investigator:||Karen Kelly||University of California, Davis|