Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy +/- AB248 (CD8-selective IL-2 Mutein Fusion Protein) in Patients With a New Diagnosis of Triple Negative Breast Cancer Undergoing Neoadjuvant Chemoimmunotherapy
Washington University School of Medicine
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPaclitaxel
As part of the KEYNOTE 522 Regimen, given per standard of care.
- DrugCarboplatin
As part of the KEYNOTE 522 Regimen, given per standard of care.
- DrugPembrolizumab
As a part of the KEYNOTE 522 Regimen, given per standard of care. Adjuvant pembrolizumab will be given per standard of care.
- DrugDoxorubicin
As part of the KEYNOTE 522 Regimen, given per standard of care.
- DrugCyclophosphamide
As part of the KEYNOTE 522 Regimen, given per standard of care.
- BiologicalPersonalized cancer vaccine (PCV)
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.
Location
- Washington University School of MedicineSt Louis, Missouri