A phase 2 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 05, 2019
O’Cearbhaill RE, Deng W, Chen LE, et al. - In view of the early-phase data demonstrating induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821, researchers examined if the hazard of progression or death could be reduced with this combination vs OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. In addition, they assessed overall survival (OS), safety, and immunogenicity as secondary outcomes. From 2010-2013, they randomized patients (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for predefined dose-limiting toxicity. Outcomes revealed that relative to OPT-821 alone, a polyvalent vaccine with adjuvant OPT-821 was modestly immunogenic and did not lead to prolongation of survival. The participants well tolerated the vaccine with adjuvant OPT-821; they exhibited only mild toxicity largely confined to the injection site reactions. For investigating innovative consolidation and maintenance approaches, they suggest multi-remission patients as a viable, well-defined population.
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