Trial results for the combination of nivolumab, cabozantinib, and ipilimumab in advanced differentiated thyroid cancer were posted on ClinicalTrials.gov on 2025-10-31. The study, NCT03914300, reported an Objective Response Rate of 0.1 (10%) for the treatment arm. This Phase 2 trial investigated the triple combination in patients with refractory differentiated thyroid gland carcinoma.

Background

The trial investigated a combination therapy for advanced differentiated thyroid cancer, specifically in patients whose disease did not respond to radioactive iodine and worsened after prior VEGFR-targeting treatment. Cabozantinib is understood to inhibit tumor cell growth by blocking enzymes. Nivolumab and ipilimumab are monoclonal antibodies that aim to stimulate the body's immune system to target cancer cells.

Trial design

The study, NCT03914300, was a Phase 2 trial with an enrollment of 11 participants. It evaluated the combination of cabozantinib s-malate, nivolumab, and ipilimumab in patients with various forms of differentiated thyroid cancer, including Differentiated Thyroid Gland Carcinoma, Follicular Variant Thyroid Gland Papillary Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Refractory Differentiated Thyroid Gland Carcinoma, and Refractory Thyroid Gland Carcinoma. The trial focused on patients whose cancer was refractory to radioactive iodine and progressed after VEGFR-targeting therapy.

Key results

For the outcome of "Objective Response Rate" in the treatment group (Cabozantinib S-malate, Nivolumab, Ipilimumab), the proportion of participants achieving an objective response was 0.1.

Regarding "Treatment Related Adverse Events (TRAEs)," the data reported the following counts of participants experiencing TRAEs: 3 participants, 4 participants, and 5 participants. These counts likely correspond to different types or severities of adverse events observed within the study cohort.

What this means

The results from this Phase 2 trial provide initial data on the efficacy and safety profile of the triple combination of nivolumab, cabozantinib, and ipilimumab for advanced differentiated thyroid cancer. An Objective Response Rate of 0.1 suggests that a subset of patients may respond to this regimen. The reported counts of participants experiencing Treatment Related Adverse Events (TRAEs) indicate that safety considerations are relevant, with between 3 and 5 out of 11 participants experiencing such events. These findings contribute to the understanding of potential treatment options for this challenging patient population, particularly those with refractory disease.

Source

The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT03914300, titled "Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer," were posted on 2025-10-31 on clinicaltrials.gov.