The primary objective of this study is to evaluate the effectiveness of zanzalintinib + MK-3475A and zanzalintinib alone compared with placebo.
Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum.
Documented local MSI and/or mismatch repair (MMR) test result demonstrating MSS, MSI-low, or pMMR status.
Colon or rectal cancer with completed definitive therapy.
ctDNA-positive based on local testing using the Natera Signatera tissue-informed molecular residual disease (MRD) assay.
History of solid organ or allogeneic stem cell transplant.
Known additional malignancy that is progressing or has required active treatment within the past 2 years.
Prior treatment with immune checkpoint inhibitors (ICIs) or Vascular endothelial growth factor receptor (VEGFR) inhibitors.
History of CRC requiring systemic anticancer therapy prior to the definitive therapy.
Exelixis
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator