Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

  • End date
    Feb 9, 2025
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 8 December 2021
monoclonal antibodies


Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cabozantinib and nivolumab in patients with metastatic MSS CRC in the third line setting and beyond.


This is an open-label, single-arm, 2-stage, phase II study of cabozantinib in combination with nivolumab in patients with refractory metastatic CRC. Up to 46 evaluable patients will be treated with cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days. One cycle is defined as 28 days.

Condition Malignant neoplasm of colon, Colon Cancer Screening, colorectal cancers, rectal carcinoma, Adenocarcinoma of the Colon, adenocarcinoma of colon, Rectal Cancer, tumors, colorectal, colon carcinoma, Colon cancer; rectal cancer, colorectal tumor, Colorectal Cancer, Colorectal Adenocarcinoma, Adenocarcinoma of Rectum, Rectal disorder, Rectal Disorders, Colon Cancer, colorectal neoplasm, cancer, colorectal, Colon Adenocarcinoma, Rectal Adenocarcinoma
Treatment Nivolumab, Cabozantinib
Clinical Study IdentifierNCT04963283
SponsorUniversity of Colorado, Denver
Last Modified on8 December 2021


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