TPIV100 / Marker Therap - LARVOL DELTA

Phase II trial to evaluate immune-related biomarkers for pathological response in stage II-III HER2-positive breast cancer receiving neoadjuvant chemotherapy with subsequent randomization to multi-epitope HER2 vaccine versus placebo in patients with residual disease post-neoadjuvant chemotherapy. (ASCO 2022) - P2 | "Eligible patients include those with stage II-III HER2+ with residual disease, in the breast and/or lymph nodes, after trastuzumab ± pertuzumab-based NAC, with ECOG PS ≤ 2 and adequate organ function...TPIV100 or placebo, in combination with GM-CSF, will be given concurrently with T-DM1...Currently, 20 patients in the run-in phase have been enrolled. Enrollment to the randomized phase II portion is expected to begin in March 2022."

Biomarker • Clinical • P2 data • Residual disease • Breast Cancer • Cardiovascular • Congestive Heart Failure • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Human Immunodeficiency Virus • Immunology • Infectious Disease • Myocardial Infarction • Oncology • Solid Tumor • CD4 • CSF2 • HER-2 • IFNG

TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery (clinicaltrials.gov) - P2; N=480; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Biomarker • Clinical • Enrollment open