Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer
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- STATUS
- Recruiting
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- End date
- Feb 9, 2025
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- participants needed
- 46
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- sponsor
- University of Colorado, Denver
Summary
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.
Description
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.
Details
| 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 Identifier | NCT04963283 |
| Sponsor | University of Colorado, Denver |
| Last Modified on | 8 December 2021 |
Eligibility
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