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A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease.
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease. These methods collectively use the body's immune system to target the patient's own tumor. Immunosuppression hinders that response, and may develop in NSCLC patients in a variety of ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the immune system. Tumor expression of PD-L1 plays an important role in patient response to checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Arizona Cancer Center
Tucson, Arizona, United States
UC San Diego
La Jolla, California, United States
BRRH Lynn Cancer Institute
Boca Raton, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Horizon Oncology Research
Lafayette, Indiana, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Oncology Hematology
Albany, New York, United States
Winthrop Hospital
Mineola, New York, United States
Start Date
April 15, 2015
Primary Completion Date
May 3, 2021
Completion Date
November 4, 2022
Last Updated
September 21, 2023
121
ACTUAL participants
Viagenpumatucel-L
BIOLOGICAL
Nivolumab
DRUG
Pembrolizumab
DRUG
Pemetrexed
DRUG
Lead Sponsor
Heat Biologics
NCT07190248
NCT06305754
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080