A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: II
Principal Investigator: Ganti, Apar
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05242965?term=NCT05242965&rank=1#participation-criteria
Summary
Primary Endpoints
1. Percentage of CD8+ TIL in patients between the two arms. Immunohistochemical (IHC) staining for CD3, CD4, and CD8 will be performed on the biopsies collected pre-treatment and post 3 vaccine administration.
2. Safety will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, physical exam and laboratory tests.
Secondary Endpoints
1. STEMVAC induced immunity in combination with pembrolizumab +/- pemetrexed. Chemoimmunotherapy might impact the immune response generated to STEMVAC. We will measure the magnitude of the Th1 STEMVAC specific immune response using IFN-g ELISPOT.
2. T-cells traffic to tumor and can eliminate cancer cells which have undergone EMT. We will assess TCR-beta (TCRb) gene usage in both T-cell lines expanded from peripheral blood and in the tumor biopsy, and the expression of EMT related genes in the tumor after vaccination with STMEVAC+GM-CSF or GM-CSF alone.
3. Clinical Efficacy of the vaccine. We will evaluate clinical response three weeks after the 3rd vaccine using RECIST 1.1. Although the study is not powered to definitively address overall response rate (ORR), data generated may give some indication of clinical utility.
4. T-cell activation and Type I lymphocyte markers will be evaluated by IHC staining in pre- and post-vaccine biopsies. We will evaluate CD4+Tbet+ (Th1), CD4+GATA3+ (Th2) and activation markers (GZB, CD127, and PD-1) on CD8 T-cells in tumor biopsies.