Overview
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
Eligibility
Key Inclusion Criteria:
- 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.
- No radiographic evidence of disease, as confirmed by a negative baseline computed tomography (CT) of the chest, abdomen, and pelvis (CAP), or CT of chest and magnetic resonance imaging (MRI) of abdomen/pelvis.
Key Exclusion Criteria:
- 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.
- Use of systemic anticancer therapy (including investigational therapy) or radiation therapy after the completion of definitive therapy.
- Administration of a live, attenuated vaccine within 30 days of randomization and during treatment.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
