Study on Combining Two Immunotherapies (Cabozantinib and Nivolumab) for Treating Advanced Melanoma or Squamous Cell Head and Neck Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05136196
This clinical trial is exploring the effects of combining two drugs, cabozantinib and nivolumab, to treat patients with advanced melanoma or squamous cell head and neck cancer. The study aims to see if this combination can help control the cancer and how patients respond based on specific markers in their tumors.
Patient Parameters
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Program Overview
This study is testing a combination of two drugs, cabozantinib and nivolumab, to treat advanced melanoma or squamous cell head and neck cancer. Cabozantinib may help stop cancer cells from growing by blocking certain enzymes, while nivolumab is an immunotherapy that helps the immune system attack cancer cells. The trial will also look at specific markers in the tumors to see if they affect how well the treatment works. These markers include 'tumor mutational burden' and 'tumor inflammation signature.' The study will help doctors understand if these drugs can shrink or stabilize the cancer and if patients respond differently based on these markers.
Description
The main goals of this study are to see how quickly doctors can use tumor markers to group patients and to evaluate how effective the combination of cabozantinib and nivolumab is in treating advanced melanoma or squamous cell head and neck cancer. The study will also assess the safety and tolerability of this treatment.
Patients will receive nivolumab through an IV and take cabozantinib orally every day. This treatment cycle repeats every 28 days for up to 2 years, as long as the cancer does not progress and side effects are manageable. Throughout the trial, patients will have regular scans and blood tests, and they may have a tumor biopsy at the start and during follow-up.
After finishing the treatment, patients will have follow-up visits every 12 weeks for the first year and then every 6 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Must have advanced melanoma or squamous cell head and neck cancer that cannot be removed by surgery or has spread.
- Must have measurable disease.
- Must have had disease progression during or shortly after previous PD-1 checkpoint inhibitor therapy.
- Must be 18 years or older.
- Must have good overall health with a performance status of 0 or 1.
- Must not have significant organ dysfunction or active infections.
- Must not have received more than one prior radiation treatment to the head and neck.
- Must not have received anti-VEGF therapies before.
- Must be able to take oral medication.
- Must not have active autoimmune diseases requiring systemic steroids.
- Must not have a history of significant bleeding or require certain blood thinners.
- Must not have uncontrolled high blood pressure.
- Must not be pregnant or nursing and must agree to use effective contraception.
- Must provide a tumor sample for analysis or be willing to undergo a biopsy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Rocky Mountain Regional VA Medical Center | 80045 | Aurora | Colorado |
| UCHealth Memorial Hospital Central | 80909 | Colorado Springs | Colorado |
| Memorial Hospital North | 80920 | Colorado Springs | Colorado |
| Poudre Valley Hospital | 80524 | Fort Collins | Colorado |
| Cancer Care and Hematology-Fort Collins | 80528 | Fort Collins | Colorado |
| UCHealth Greeley Hospital | 80631 | Greeley | Colorado |
| Medical Center of the Rockies | 80538 | Loveland | Colorado |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
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