Washington University School of Medicine
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.
Step 0 Inclusion Criteria: * Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO/CAP guidelines). Permissible staging per AJCC is as follows: * T1c, N1-N2 * T2, N0-N2 * T3, N0-N2 * At least 18 years of age. * Adequate tissue available for nucleic acid isolation/PCV design or willing to undergo biopsy if adequate tissue is not available. * Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month). Note t…
As part of the KEYNOTE 522 Regimen, given per standard of care.
As part of the KEYNOTE 522 Regimen, given per standard of care.
As a part of the KEYNOTE 522 Regimen, given per standard of care. Adjuvant pembrolizumab will be given per standard of care.
As part of the KEYNOTE 522 Regimen, given per standard of care.
As part of the KEYNOTE 522 Regimen, given per standard of care.
PCV is given intra-muscular (IM). Each PCV will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.
AB248 is given intravenously (IV) over 30 minutes at the recommended dose.
The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.
Poly-ICLC is mixed with the personalized cancer vaccine (PCV). The PCV is given intramuscularly (IM) at 1mg dose.
Arctuva estimate
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