NCT04197310

Cabozantinib and Nivolumab for Carcinoid Tumors

Phase II Trial of Cabozantinib in Combination With Nivolumab for Advanced Carcinoid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study, is studying the combination of cabozantinib and nivolumab in treating advanced carcinoid tumors. \- Carcinoid tumor is another term used to refer to neuroendocrine tumors that arise in organs such as the gastrointestinal tract, lungs, or thymus.

Detailed description

This is open-label, single-arm, phase II research study, studying the combination of cabozantinib and nivolumab in treating advanced carcinoid tumors. Carcinoid tumor is another term used to refer to neuroendocrine tumors that arise in organs such as the gastrointestinal tract, lungs, or thymus. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Cabozantinib will be administered orally, once daily * Nivolumab will be administered intravenously, every two weeks * The target enrollment for this study is 35 participants. * The U.S. Food and Drug Administration (FDA) has not approved cabozantinib or nivolumab for treating carcinoid tumors.

Conditions

• Carcinoid Tumor
• Carcinoid Tumor of GI System
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Nivolumab	240mg, intravenously, Day 1 and 15 of a 28 day cycle
DRUG	Cabozantinib	40mg, orally, Daily for a 28 day cycle

Timeline

• Start date: 2019-12-26
• Primary completion: 2023-12-27
• Completion: 2024-01-31
• First posted: 2019-12-13
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study