Cabozantinib and Nivolumab for Carcinoid Tumors
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|ClinicalTrials.gov Identifier: NCT04197310|
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : January 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoid Tumor Carcinoid Tumor of GI System Neuroendocrine Tumors||Drug: Nivolumab Drug: Cabozantinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Cabozantinib in Combination With Nivolumab for Advanced Carcinoid Tumors|
|Actual Study Start Date :||December 26, 2019|
|Estimated Primary Completion Date :||December 26, 2021|
|Estimated Study Completion Date :||December 26, 2022|
Experimental: Nivolumab and Cabozantinib
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Retreat Phase (Optional)
240mg, intravenously, Day 1 and 15 of a 28 day cycle
Other Name: Opdivo
40mg, orally, Daily for a 28 day cycle
- Objective Response Rate (ORR) [ Time Frame: 2 years ]Determine the number of patients who demonstrated a clinical response assessed by RECIST 1.1 criteria on imaging to the combination of Cabozantinib and Nivolumab
- Progression-free survival (PFS) [ Time Frame: 2 years ]Determine the progression free survival, by using RECIST 1.1, derived from the combination of Cabozantinib and Nivolumab.
- Overall Response Rate (ORR) per immune-related response criteria [ Time Frame: 2 years ]ORR will be determined according to immune-related response criteria (irRC).
- Overall survival (OS) [ Time Frame: 2 years ]Evaluate OS in patients receiving the combination of Cabozantinib and Nivolumab.
- Number of Participants with Treatment Related Adverse Events [ Time Frame: 2 years ]Toxicities will be defined according to NCI CTCAE version 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197310
|Contact: Kimberly Perez, MD||877-DF-TRIAL||Kimberly_perez@dfci.harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Kimberly Perez, MD 617-632-5960 Kimberly_perez@dfci.harvard.edu|
|Principal Investigator: Kimberly Perez, MD|
|Principal Investigator:||Kimberly Perez, MD||Dana-Farber Cancer Institute|