Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

Summary

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). 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. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.

Timeline

Start

2015-08-13

Primary completion

2019-04-01

Completion

2023-04-01

Outcome

Mixed primary results

paper In DDLPS and UPS, the primary response endpoint of CRR was met with N+I (both 16.6%, 2/12) but not with N alone (both 8.3%, 1/12). PMID 39343511 ↗

paper The combination therapy met its predefined primary study endpoint; further evaluation of nivolumab plus ipilimumab in a randomised study is warranted. PMID 29370992 ↗

Publications

• Seligson ND, Chen JL, Goodrich AC, Van Tine BA, Campbell JD, Richards AL, Antonescu CR, Liebner DA, Milhem MM, Streicher H, Tap WD, Schwartz GK, George S, D'Angelo SP. A multicenter, randomized, non-comparative, phase II study of nivolumab +/- ipilimumab for patients with metastatic sarcoma (Alliance A091401): expansion cohorts and correlative analyses. J Immunother Cancer. 2024 Sep 28;12(9):e009472. doi: 10.1136/jitc-2024-009472.
• D'Angelo SP, Mahoney MR, Van Tine BA, Atkins J, Milhem MM, Jahagirdar BN, Antonescu CR, Horvath E, Tap WD, Schwartz GK, Streicher H. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018 Mar;19(3):416-426. doi: 10.1016/S1470-2045(18)30006-8. Epub 2018 Jan 19.

Drugs

Indications