Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer

Conditions

• Differentiated Thyroid Gland Carcinoma
• Follicular Variant Thyroid Gland Papillary Carcinoma
• Poorly Differentiated Thyroid Gland Carcinoma
• Refractory Differentiated Thyroid Gland Carcinoma
• Refractory Thyroid Gland Carcinoma
• Tall Cell Variant Thyroid Gland Papillary Carcinoma
• Thyroid Gland Follicular Carcinoma
• Thyroid Gland Oncocytic Carcinoma
• Thyroid Gland Papillary Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Ipilimumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab and ipilimumab may work better than the usual approach consisting of chemotherapy with drugs such as doxorubicin, sorafenib, and lenvatinib for this type of thyroid cancer.

Key Dates

Start date

Feb 10, 2020

Status verified

Dec 2025

Primary completion

Oct 17, 2024

Completion

Dec 17, 2026

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cabozantinib S-malate, nivolumab, ipilimumab)
  Patients receive cabozantinib S-malate PO QD on days -14 to -1 prior to cycle 1, days 1-42 of cycles 1-4 and days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1, 15, and 29 of cycles 1-4 and day 1 of subsequent cycles and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Treatment repeats every 42 days for cycles 1-4 and every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening, and blood sample collection throughout the study.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 6 months after initiation of therapy ]

Locations (33)

Related coverage on Hipa.ai

• Nivolumab, Cabozantinib, Ipilimumab Combination Shows 0.1 ORR in Thyroid Cancer
  Nivolumab · Oct 31, 2025 · ClinicalTrials.gov

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