AIPAC: a Phase IIb study of eftilagimod alpha (IMP321 or LAG-3Ig) added to weekly paclitaxel in patients with metastatic breast cancer.

Abstract	Eftilagimod alpha (IMP321), a soluble dimeric recombinant form of LAG-3, is a first-in-class antigen presenting cell activator under clinical development. By stimulating dendritic cells through MHC class II molecules, IMP321 was proven to induce sustained immune responses. Combining active immunotherapy with a standard cytotoxic chemotherapy regimen represents a promising novel strategy that might lead to therapeutic improvements in metastatic breast cancer. Here, we describe the rationale and design of AIPAC (NCT02614833), a double-blind, randomized, multicenter Phase IIb study evaluating IMP321 plus paclitaxel as a first-line chemotherapy compared with paclitaxel plus placebo in hormone receptor-positive metastatic breast cancer patients. The primary end point is progression-free survival and key secondary objectives include overall survival, safety, quality of life and objective response rate.
Authors	Luc Dirix, Frédéric Triebel
Journal	Future oncology (London, England) (Future Oncol) Vol. 15 Issue 17 Pg. 1963-1973 (Jun 2019) ISSN: 1744-8301 [Electronic] England
PMID	30977393 (Publication Type: Clinical Trial Protocol, Journal Article)
Chemical References	Antigens, CD Antineoplastic Agents, Immunological Placebos Recombinant Proteins Paclitaxel Lymphocyte Activation Gene 3 Protein Lag3 protein, human soluble LAG-3 protein, human
Topics	Adult Antigens, CD (administration & dosage, adverse effects) Antineoplastic Agents, Immunological (administration & dosage, adverse effects) Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects) Breast Neoplasms (drug therapy, mortality, pathology) Clinical Trials, Phase II as Topic Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Humans Multicenter Studies as Topic Paclitaxel (administration & dosage, adverse effects) Placebos (administration & dosage, adverse effects) Progression-Free Survival Quality of Life Randomized Controlled Trials as Topic Recombinant Proteins (administration & dosage, adverse effects) Lymphocyte Activation Gene 3 Protein

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