A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma

Phase 2 Terminated 6 enrolled Ludwig Institute for Cancer Research Medarex · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is effective in people with advanced synovial sarcoma.

Timeline

Start: 2005-06-08
Primary completion: 2007-04-18
Completion: 2007-07-01

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study discontinued due to poor accrual.”

paper All patients showed clinical or radiological evidence of disease progression after no more than three cycles of therapy, for a RECIST response rate of 0%. PMID 23554566 ↗

Publications

Background Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
Results Maki RG, Jungbluth AA, Gnjatic S, Schwartz GK, D'Adamo DR, Keohan ML, Wagner MJ, Scheu K, Chiu R, Ritter E, Kachel J, Lowy I, Old LJ, Ritter G. A Pilot Study of Anti-CTLA4 Antibody Ipilimumab in Patients with Synovial Sarcoma. Sarcoma. 2013;2013:168145. doi: 10.1155/2013/168145. Epub 2013 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous