Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
Summary
The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.
Timeline
- Start
- 2006-12
- Primary completion
- 2010-12
- Completion
- 2011-06
Outcome
Missed primary endpoint
Stopped: “No benefit on primary end point (RFS); no rationale to collect survival data”
registry p = 0.301; Hazard Ratio (HR) 1.099 (95% CI) 0.919 to 1.315 NCT00418574 ↗
paper Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS. PMID 23478059 ↗
release “vaccinations carried out using Abagovomab did not confirm the expected levels of benefit foreseen during the initial studies.” menarini.com ↗
Publications
- Background Reinartz S, Kohler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Mobus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7. doi: 10.1158/1078-0432.ccr-03-0056.
- Background Wagner U, Kohler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Mobus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.
- Background Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77. doi: 10.1093/annonc/mdl357.
- Background Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10. doi: 10.1158/1078-0432.CCR-05-2670.
- Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.
- Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abagovomab | Monoclonal antibody | 2 mg | Subcutaneous |