Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma

Summary

This phase II trial studies how well ipilimumab with or without nivolumab work in treating patients with melanoma that is stage IV or stage III and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Timeline

Start

2017-10-23

Primary completion

2023-09-19

Completion

2024-03-20

Outcome

Met primary endpoint

paper The combination of nivolumab and ipilimumab resulted in a statistically significant improvement in progression-free survival over ipilimumab PMID 37592104 ↗

registry analysis (superiority test); Ipilimumab vs Nivolumab + Ipilimumab; p = 0.04; Hazard Ratio (HR) 0.63 (90% CI 0.41 to 0.97) NCT03033576 ↗

Publications

• VanderWalde A, Bellasea SL, Kendra KL, Khushalani NI, Campbell KM, Scumpia PO, Kuklinski LF, Collichio F, Sosman JA, Ikeguchi A, Victor AI, Truong TG, Chmielowski B, Portnoy DC, Chen Y, Margolin K, Bane C, Dasanu CA, Johnson DB, Eroglu Z, Chandra S, Medina E, Gonzalez CR, Baselga-Carretero I, Vega-Crespo A, Garcilazo IP, Sharon E, Hu-Lieskovan S, Patel SP, Grossmann KF, Moon J, Wu MC, Ribas A. Ipilimumab with or without nivolumab in PD-1 or PD-L1 blockade refractory metastatic melanoma: a randomized phase 2 trial. Nat Med. 2023 Sep;29(9):2278-2285. doi: 10.1038/s41591-023-02498-y. Epub 2023 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	—	Intravenous
Subject	Nivolumab	Monoclonal antibody	—	Intravenous

Indications