Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free

Summary

Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been removed surgically or treated with radiation or chemotherapy. The patients in the study will be randomized (like flipping a coin) to receive either a vaccine that is combined with an immune system stimulant or the immune system stimulant alone. The immune system stimulant is called OPT-821 and is an immunological booster. The trivalent vaccine is being developed to teach the patient's immune system to recognize 3 types of sugars called GM2, GD2 and GD3 that are found primarily on the surface of sarcoma cells. If the trivalent vaccine can stimulate the patient's immune system to develop antibodies which recognize and target the GM2, GD2 and GM3 sugars, then the patient's antibodies could attack and kill any remaining sarcoma cells potentially preventing the recurrence of sarcoma.

Timeline

Start

2010-06

Primary completion

2013-09

Completion

2017-03-10

Publications

• Rosenbaum E, Chugh R, Ryan CW, Agulnik M, Milhem MM, George S, Jones RL, Chmielowski B, Van Tine BA, Tawbi H, Elias AD, Read WL, Budd GT, Qin LX, Rodler ET, Hirman J, Weiden P, Bennett CM, Livingston PO, Ragupathi G, Hansen D, D'Angelo SP, Tap WD, Schwartz GK, Maki RG, Carvajal RD. A randomised phase II trial of a trivalent ganglioside vaccine targeting GM2, GD2 and GD3 combined with immunological adjuvant OPT-821 versus OPT-821 alone in metastatic sarcoma patients rendered disease-free by surgery. Eur J Cancer. 2022 Nov;176:155-163. doi: 10.1016/j.ejca.2022.09.003. Epub 2022 Oct 8.
• Cheung IY, Cheung NV, Modak S, Mauguen A, Feng Y, Basu E, Roberts SS, Ragupathi G, Kushner BH. Survival Impact of Anti-GD2 Antibody Response in a Phase II Ganglioside Vaccine Trial Among Patients With High-Risk Neuroblastoma With Prior Disease Progression. J Clin Oncol. 2021 Jan 20;39(3):215-226. doi: 10.1200/JCO.20.01892. Epub 2020 Dec 16.

Drugs

Indications