Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.

Trial Details

NCT ID
NCT07750158
Phase
PHASE3
Sponsor
Exelixis
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Zanzalintinib
  • Pembrolizumab (+) Berahyaluronidase alfa
  • Placebo
Locations (sample)
  • Council Bluffs, Iowa, United States|41.26194,-95.86083
  • Grand Island, Nebraska, United States|40.92501,-98.34201
  • Grand Island, Nebraska, United States|40.92501,-98.34201
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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