Study on Cabozantinib, Nivolumab, and Ipilimumab for Advanced Thyroid Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03914300
This clinical trial is testing a new combination of drugs—cabozantinib, nivolumab, and ipilimumab—to see if they can better treat advanced thyroid cancer that hasn't responded to other treatments. The study aims to find out if this combination can stop cancer growth more effectively than current treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring whether a combination of three drugs—cabozantinib, nivolumab, and ipilimumab—can help treat advanced thyroid cancer that doesn't respond to radioactive iodine and has worsened after other treatments. Cabozantinib may block enzymes that help cancer cells grow, while nivolumab and ipilimumab are immunotherapy drugs that may help the immune system attack cancer cells. Researchers hope this combination will work better than standard chemotherapy for this type of thyroid cancer.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer size within the first 6 months of treatment with cabozantinib, nivolumab, and ipilimumab. Researchers will also look at how long these responses last, how long patients live without the cancer getting worse, and overall survival rates. They will monitor any side effects and how well patients tolerate the treatment.
The study will also explore how the treatment affects certain immune cells and proteins in the body and how these changes relate to the treatment's effectiveness. Patients will take cabozantinib by mouth daily and receive nivolumab and ipilimumab through an IV on specific days. The treatment cycles repeat every 42 days for the first four cycles and every 28 days for later cycles, as long as the cancer doesn't progress or side effects aren't too severe. Patients will have regular scans and blood tests to monitor their health and the cancer's response to treatment.
After finishing the treatment, patients will have follow-up visits every 6 weeks initially, then every 12 weeks for up to 2 years to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of certain types of thyroid cancer, such as papillary, follicular, or Hurthle cell thyroid cancer.
- The cancer must be measurable and not respond to radioactive iodine treatment.
- The cancer must have worsened after treatment with a VEGFR-targeted drug.
- Be 18 years or older.
- Be in relatively good health with a performance status score of 0 to 2.
- Have adequate blood counts and organ function based on specific tests.
- Women of childbearing potential must use effective birth control during the study and for 5 months after the last dose. Men must use birth control for 7 months after the last dose.
- Be able to swallow tablets and understand the study requirements.
- Have a legally authorized representative if decision-making capacity is impaired.
Exclusion Criteria
- Have had previous treatment with cabozantinib or similar drugs.
- Have a tumor invading major blood vessels or the gastrointestinal tract.
- Have another type of cancer within the last 2 years, except for certain skin cancers or low-grade tumors.
- Have untreated brain metastases or require certain medications that could interfere with the study.
- Have significant heart, lung, or other medical conditions that could affect participation.
- Be pregnant or breastfeeding.
- Have active autoimmune diseases that require treatment with high-dose steroids or other immunosuppressive drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Kansas Clinical Research Center | 66205 | Fairway | Kansas |
| HaysMed | 67601 | Hays | Kansas |
| University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.