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Cabozantinib and Nivolumab for Carcinoid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Cabozantinib and Nivolumab for Carcinoid Tumors

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

NCT04197310•Dana-Farber Cancer Institute

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with locally unresectable or metastatic well-differentiated neuroendocrine tumor of non-pancreatic (ie, carcinoid) origin
•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
•Patients must have evidence of radiographic disease progression within the past 12 months.
•Patients who have received at least one line of therapy, which can include somatostatin analog therapy. Participants should be adequately recovered from acute toxicities of prior treatment.
•* Prior somatostatin analog therapy is allowed. Continuation of somatostatin analog therapy is allowed provided that the dose has been stable for 2 months.
•* Prior chemotherapy: Participants must have been off treatment with cytotoxic chemotherapy for at least 14 days prior to registration.
•* Prior biologic therapy: Patients must have discontinued all biologic therapy at least 28 days prior to registration. Duration may be shorted to 14 days for agents with short half-lives.
•* Prior radiolabeled somatostatin analog therapy: Participants must have completed radiolabeled somatostatin analog therapy at least 6 weeks prior to registration.
•* Prior hepatic artery embolization or ablative therapies is allowed if measurable disease remains outside the treated area or there is documented disease progression in a treated site. Prior liver-directed or ablative treatment must be completed at least 28 days prior to registration.
•* Prior radiation therapy: Radiation therapy must be completed per the following timelines
+24 more criteria

Exclusion Criteria

•Participants who are receiving any other investigational agents.
•Participants who have received a prior cabozantinib.
•Participants who have received prior therapy with an anti-PD-1, anti-PD-L1, anti- PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including nivolumab, pembrolizumab, ipilimumab, and any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
•Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•The participant has tumor in contact with, invading, or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib or nivolumab.
•Participants receiving any strong inhibitors or inducers of CYP3A4 within 14 days prior to registration are ineligible. Chronic treatment with strong inhibitors or inducers of CYP3A4 is not allowed.
•Cardiovascular disorders including:
•* Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening;
•* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
+16 more criteria

Locations (2)

Boston Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

December 26, 2019

Primary Completion Date

December 27, 2023

Completion Date

January 31, 2024

Last Updated

January 31, 2025

Enrollment

ACTUAL participants

Conditions

Carcinoid TumorCarcinoid Tumor of GI SystemNeuroendocrine Tumors

Interventions

Nivolumab

DRUG

Cabozantinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cabozantinib and Nivolumab for Carcinoid Tumors

Inclusion Criteria

Exclusion Criteria

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

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