Study of Cabozantinib and Nivolumab for Hard-to-Treat Metastatic Colorectal Cancer
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT04963283
This clinical trial is testing a combination of two drugs, cabozantinib and nivolumab, to see if they can help treat metastatic colorectal cancer that hasn't responded to other treatments. The study involves taking cabozantinib daily and receiving nivolumab every 28 days.
Patient Parameters
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Program Overview
This study is exploring a new treatment for metastatic colorectal cancer that hasn't responded to previous therapies. The treatment combines two drugs: cabozantinib, taken as a daily pill, and nivolumab, given as an infusion every 28 days. Researchers want to see if this combination can help control the cancer in patients who have already tried other treatments without success.
Description
This is a phase II study where all participants will receive the same treatment. Up to 46 patients will take part, receiving cabozantinib as a daily oral medication and nivolumab as an intravenous infusion every 28 days. The study aims to find out if this combination can help manage metastatic colorectal cancer that hasn't responded to other treatments. Participants will be closely monitored for any side effects and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic or inoperable colorectal cancer.
- Cancer has not responded to previous treatments, including specific chemotherapy drugs and, for some patients, epidermal growth factor inhibitors.
- Cancer must be microsatellite stable (MSS) or have proficient mismatch repair (pMMR).
- Must have measurable disease as determined by scans.
- Must be 18 years or older.
- Must be in good overall health with a performance status of 0 or 1.
- Must have recovered from any side effects of previous treatments.
- Must provide a tissue sample for analysis.
- Must have adequate organ and bone marrow function as shown by specific blood tests.
- Women of childbearing potential must agree to use contraception during the study and for 5 months after.
- Men must agree to use contraception during the study and for 7 months after.
Exclusion Criteria
- Cancer is microsatellite-high (MSI-H) or has deficient mismatch repair (dMMR).
- Recent treatment with certain chemotherapy or biological agents.
- Previous treatment with cabozantinib or similar drugs.
- Previous treatment with certain immune therapies.
- Recent radiation therapy or investigational treatments.
- Known brain metastases unless treated and stable.
- Certain blood clotting issues or use of specific blood thinners.
- Recent significant bleeding or certain lung conditions.
- Tumor invading major blood vessels or the gastrointestinal tract.
- Uncontrolled health conditions, including heart issues or gastrointestinal disorders.
- Recent major surgery or inability to swallow pills.
- Pregnant or breastfeeding women.
- Known allergies to study drugs.
- Other active cancers or autoimmune diseases.
- Recent use of steroids or immunosuppressive drugs.
- History of certain infections or organ transplants.
- Recent live vaccinations.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Hospital | 80012 | Aurora | Colorado |
| UCHealth Memorial Hospital Central | 80909 | Colorado Springs | Colorado |
| UCHealth Harmony Campus | 80528 | Fort Collins | Colorado |
| UCHealth Family Medicine - Greeley | 80634 | Greeley | Colorado |
| UCHealth Medical Center of the Rockies | 80538 | Loveland | Colorado |
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