Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
Summary
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.
Timeline
- Start
- 2011-06-17
- Primary completion
- 2019-02-15
- Completion
- 2027-02-02
Outcome
Mixed primary results
registry analysis (superiority test); Arm B (HDI) vs Arm C (LIP); p = 0.065; Log Rank NCT01274338 ↗
registry MEDIAN Arm B (HDI): 2.5 (1.7 to 3.3) years MEDIAN Arm C (LIP): 4.5 (2.6 to NA) years NCT01274338 ↗
registry NUMBER Arm B (HDI): 0.67 (0.62 to 0.72) proportion of participants NUMBER Arm C (LIP): 0.72 (0.68 to 0.76) proportion of participants NCT01274338 ↗
registry analysis (superiority test); Arm B (HDI) vs Arm C (LIP); p = 0.044; Log Rank NCT01274338 ↗
registry NUMBER Arm A (HIP): 0.70 (0.65 to 0.74) proportion of participants NUMBER Arm B (HDI): 0.65 (0.60 to 0.70) proportion of participants NCT01274338 ↗
registry analysis (superiority test); Arm A (HIP) vs Arm B (HDI); p = 0.289; Log Rank NCT01274338 ↗
Publications
- McLouth LE, Zheng Y, Smith S, Hodi FS, Rao UN, Cohen GI, Amatruda TT, Dakhil SR, Curti BD, Nakhoul I, Chandana SR, Bane CL, Marinier DE, Lee SJ, Sondak VK, Kirkwood JM, Tarhini AA, Wagner LI. Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609. Qual Life Res. 2023 Jan;32(1):183-196. doi: 10.1007/s11136-022-03226-8. Epub 2022 Aug 27.
- Saad M, Lee SJ, Tan AC, El Naqa IM, Hodi FS, Butterfield LH, LaFramboise WA, Storkus W, Karunamurthy AD, Conejo-Garcia J, Hwu P, Streicher H, Sondak VK, Kirkwood JM, Tarhini AA. Enhanced immune activation within the tumor microenvironment and circulation of female high-risk melanoma patients and improved survival with adjuvant CTLA4 blockade compared to males. J Transl Med. 2022 Jun 3;20(1):253. doi: 10.1186/s12967-022-03450-3.
- Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Recombinant Interferon Alfa-2b | Protein / enzyme biologic | — | Intravenous |