Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Summary
This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). 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.
Timeline
- Start
- 2015-05-13
- Primary completion
- 2025-02-15
- Completion
- 2027-03-20
Outcome
Missed primary endpoint
registry analysis (superiority test); Part B Arm I (Nivolumab) vs Part B Arm II (Nivolumab, Ipilimumab; p = 0.25; Log Rank NCT02314169 ↗
paper The addition of ipilimumab to nivolumab did not statistically improve overall response rate, PFS, or OS but may harbor increased toxicity. PMID 41499716 ↗
Publications
- Morris VK, Ciombor KK, Xiao L, Ochieng JK, Marmonti E, Polite B, Weinberg BA, Krauss JC, Hays J, Mukherjee S, Aranha O, Iqbal S, Shields T, Benson AB, Kazmi S, Lieu C, Hochster H, Whisenant J, Haymaker C, Eng C. NCI9673 (Part B): ETCTN Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Refractory, Metastatic Squamous Cell Carcinoma of the Anal Canal. J Clin Oncol. 2026 Feb 20;44(6):497-507. doi: 10.1200/JCO-25-00929. Epub 2026 Jan 7.
- Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, Polite B, Deming D, Chan E, Wade JL, Xiao L, Bekaii-Saab T, Vence L, Blando J, Mahvash A, Foo WC, Ohaji C, Pasia M, Bland G, Ohinata A, Rogers J, Mehdizadeh A, Banks K, Lanman R, Wolff RA, Streicher H, Allison J, Sharma P, Eng C. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. doi: 10.1016/S1470-2045(17)30104-3. Epub 2017 Feb 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |