Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colorectal cancer.

Operable gastrointestinal cancers continue to pose significant challenges. Radical resections are rarely curative, and chemotherapy is able to reduce tumor recurrence for only a small percentage of patients. Despite the obvious advantages of extirpation of the identifiable tumor(s), the inflammatory milieu that accompanies surgery and the obligate time off cytotoxic agents allows for activation of remote quiescent disseminated tumor cells, leading to metastatic recurrence. We are conducting a study to determine the safety and efficacy of immediate peri-operative MVT-5873, a cytotoxic monoclonal antibody targeting carbohydrate antigen 19-9 (CA 19-9), in patients undergoing resections pancreatic cancer, cholangiocarcinoma or metastatic colorectal cancer to the liver. Eligible patients will receive a single dose of MVT-5873 three days before resection and four post-operative infusions, before beginning standard adjuvant regimens. MVT-5873 is a human IgG1 antibody isolated from a patient following immunization with a sLea-KLH vaccine. MVT-5873 demonstrated cell surface binding in sLea positive human tumor lines and has been shown to be potent in complement-dependent cytotoxicity assays and antibody-dependent cell mediated cytotoxicity assays. In patients with metastatic CA 19-9 producing pancreatic adenocarcinoma, MVT-5873 treatment has been shown to decrease serum CA 19-9 levels and prevent tumor progression. The use of perioperative MVT-5873 has the potential to reduce recurrence rates and prolong survival after resection. This trial may open the door for investigation of additional and/or synergistic agents in the immediate peri-operative period and usher in a new paradigm in the management of surgically treated cancers. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03801915?term=MVT&rank=3. 2020 Journal of Gastrointestinal Oncology. All rights reserved.