Stopped: Industry sponsor decision
This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2 positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety of the novel combination of subcutaneously administered IMA950 peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating patients.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT)
Timeframe: up to 2 years
Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC)
Timeframe: Up to 2 years
Mean Percentage of CD4+ T-cell Responses in Pre- and Post-vaccine PBMC
Timeframe: Up to 2 years