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A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 vs OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study

Gynecologic Oncology Nov 26, 2019

O’Cearbhaill RE, Deng W, Chen LM, et al. - Since the induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821 has been shown in early-phase data, researchers investigated if a reduction in the hazard of progression or death may be seen in relation to this combination vs OPT-821 alone among patients with ovarian cancer in second/third clinical complete remission after chemotherapy. They also focused on overall survival (OS), safety, and immunogenicity as secondary and translational goals. Randomization (1:1) of patients to receive OPT-821 ± vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11), was done from 2010–2013. Overall 170 were treated out of 171 patients randomized. Discontinuation was reported in 77%, 4%, and in 1 case because of progression, toxicity, and myeloid dysplastic syndrome, respectively. For progression-free survival (PFS), the HR of the vaccine + OPT-821 to OPT-821 arm was estimated to be 0.98. Findings revealed modest immunogenicity of vaccine + OPT-821 vs OPT-821 alone. The former vs the latter did not prolong PFS or OS. Multi-remission patients represent a viable, well-defined population for investigating innovative consolidation and maintenance strategies.
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