Cabozantinib plus ipilimumab/nivolumab in patients with previously treated advanced differentiated thyroid cancer Journal Article
| Authors: | Konda, B.; Sherman, E. J.; Massarelli, E.; Nieva, J.; Muzaffar, J.; Morris, J. C., III; Ryder, M.; Ho, A. L.; Agulnik, M.; Wei, L.; Handley, D.; Moses, C.; Jacob, R.; Wright, J.; Streicher, H.; Carson, W.; Shah, M. H. |
| Article Title: | Cabozantinib plus ipilimumab/nivolumab in patients with previously treated advanced differentiated thyroid cancer |
| Abstract: | Background This investigator-initiated phase II trial aimed to evaluate the efficacy of cabozantinib in combination with nivolumab and ipilimumab (CaboNivoIpi) in previously treated patients with radioactive iodine-refractory differentiated thyroid cancer.Methods Eligible patients with radioactive iodine-refractory differentiated thyroid cancer who progressed on 1 prior line of vascular endothelial growth factor receptor-targeted therapy received a 2-week run-in of cabozantinib monotherapy followed by CaboNivoIpi for 4 cycles (cycle length = 6 weeks), followed by cabozantinib plus nivolumab (cycle length = 4 weeks) until disease progression. The primary endpoint was objective response rate (ORR) within the first 6 months of treatment. A Simon optimal 2-stage design allowed for an interim analysis after accrual of 10 evaluable patients. At least 5 responses were needed to proceed to stage 2.Results Among 11 patients enrolled, the median age was 69 years. Prior vascular endothelial growth factor receptor-targeted therapies included lenvatinib, pazopanib, and sorafenib plus everolimus. Median follow-up was 7.9 months. Among 10 evaluable patients, ORR within the first 6 months of treatment was 10% (1 partial response). Median progression-free survival was 9 months (95% CI, 3.0-not reached) and median overall survival was 19.2 months (95% CI, 4.6-not reached). Grade 3/4 treatment-related adverse events (AEs) were noted in 55% (6/11) and grade 5 AEs in 18% (2/11) of patients. The most common treatment-related AE was hypertension. The study did not reach its prespecified efficacy threshold.Conclusion CaboNivoIpi had low ORRs and a high rate of grade >= 3 treatment-related AEs.Clinical Trial Registration NCT03914300 |
| Keywords: | placebo; ipilimumab; carcinoma; double-blind; papillary; phase-ii; inhibitors; differentiated thyroid cancer; cabozantinib; nivolumab; immune checkpoint; vegfr |
| Journal Title: | Journal of Clinical Endocrinology and Metabolism |
| Volume: | 110 |
| Issue: | 3 |
| ISSN: | 0021-972X |
| Publisher: | Oxford University Press |
| Date Published: | 2025-03-01 |
| Start Page: | 830 |
| End Page: | 837 |
| Language: | English |
| ACCESSION: | WOS:001297436200001 |
| DOI: | 10.1210/clinem/dgae512 |
| PROVIDER: | wos |
| PMCID: | PMC11834700 |
| PUBMED: | 39133806 |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Wos |
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