Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

Summary

This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). 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 shrink the cancer.

Timeline

Start

2020-08-06

Primary completion

2025-01-10

Completion

2026-08-19

Outcome

Missed primary endpoint

paper Long-term responses were observed in a small subset of patients, but the study did not meet the prespecified efficacy threshold for continued accrual. PMID 41968073 ↗

Publications

• Mandl A, Chen R, Das S, Strosberg JR, Kasi A, Konda B, Li D, Burns TF, Chauhan A, Ciombor KK, Dayyani F, Dorff T, Ohr JP, Patel BB, Sukrithan V, Soares HP, Chen K, Liu SV, Tesfaye AA, Carducci MA, Beumer JH. Phase 2 study of cabozantinib (XL184) with nivolumab and ipilimumab for the treatment of poorly differentiated neuroendocrine carcinomas (ETCTN10315). Oncologist. 2026 May 8;31(6):oyag140. doi: 10.1093/oncolo/oyag140.

Drugs

Indications