Study on Combining XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Treating Poorly Differentiated Neuroendocrine Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04079712
This clinical trial is testing a combination of three drugs—XL184 (cabozantinib), nivolumab, and ipilimumab—to see if they can effectively treat poorly differentiated neuroendocrine tumors that have not responded to previous treatments.
Patient Parameters
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Program Overview
This study is exploring whether a combination of three drugs—XL184 (cabozantinib), nivolumab, and ipilimumab—can help shrink tumors in patients with poorly differentiated neuroendocrine tumors. Cabozantinib works by blocking enzymes that help tumor cells grow, while nivolumab and ipilimumab are immunotherapy drugs that help the immune system attack cancer cells. The goal is to see if this combination can reduce the size of the cancer.
Description
The main goal of this study is to see how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab works in shrinking tumors in patients with advanced poorly differentiated neuroendocrine carcinomas (NECs) who have already tried at least one other treatment.
Other goals include:
- Checking how long patients live without the cancer getting worse.
- Seeing how safe and tolerable the treatment is.
- Measuring how long the treatment keeps the cancer under control.
- Analyzing the genetic makeup of the tumors to see how it relates to treatment outcomes.
Patients will take cabozantinib by mouth daily and receive nivolumab and ipilimumab through an IV on specific days. The treatment cycles repeat every 21 days for the first four cycles and every 28 days after that, as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Have metastatic, poorly differentiated neuroendocrine tumors, excluding small cell lung cancer and Merkel cell carcinoma.
- Have tried at least one previous cancer treatment.
- Have measurable tumors that can be tracked.
- Be willing to have a biopsy before and during treatment.
- Have completed any previous cancer treatments at least four weeks before starting this study.
- Be in relatively good health with a performance status score of 0 to 2.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
- Be able to swallow tablets and understand the study requirements.
Exclusion Criteria
- Cannot be on high-dose steroids or other immune-suppressing medications.
- Cannot have had previous treatments targeting specific immune pathways or the drug XL184 (cabozantinib).
- Cannot have had recent radiation therapy or major surgery.
- Cannot be on certain blood thinners or have significant bleeding issues.
- Cannot have uncontrolled health conditions, such as severe heart or lung diseases.
- Cannot have active autoimmune diseases that require treatment.
- Cannot be pregnant or breastfeeding due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| 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 |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Sibley Memorial Hospital | 20016 | Washington D.C. | District of Columbia |
| UF Health Cancer Institute - Gainesville | 32610 | Gainesville | Florida |
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