{"doi":"10.3390/cancers15051458","title":"Phase I Study of a Multivalent WT1 Peptide Vaccine (Galinpepimut-S) in Combination with Nivolumab in Patients with WT1-Expressing Ovarian Cancer in Second or Third Remission","abstract":"We examined the safety and immunogenicity of sequential administration of a tetravalent, non-HLA (human leukocyte antigen) restricted, heteroclitic Wilms' Tumor 1 (WT1) peptide vaccine (galinpepimut-S) with anti-PD-1 (programmed cell death protein 1) nivolumab. This open-label, non-randomized phase I study enrolled patients with WT1-expressing ovarian cancer in second or third remission from June 2016 to July 2017. Therapy included six (every two weeks) subcutaneous inoculations of galinpepimut-S vaccine adjuvanted with Montanide, low-dose subcutaneous sargramostim at the injection site, with intravenous nivolumab over 12 weeks, and up to six additional doses until disease progression or toxicity. One-year progression-free survival (PFS) was correlated to T-cell responses and WT1-specific immunoglobulin (Ig)G levels. Eleven patients were enrolled; seven experienced a grade 1 adverse event, and one experienced a grade ≥3 adverse event considered a dose-limiting toxicity. Ten (91%) of eleven patients had T-cell responses to WT1 peptides. Seven (88%) of eight evaluable patients had IgG against WT1 antigen and full-length protein. In evaluable patients who received >2 treatments of galinpepimut-S and nivolumab, the 1-year PFS rate was 70%. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses, as indicated by immunophenotyping and WT1-specific IgG production. Exploratory analysis for efficacy yielded a promising 1-year PFS rate.","journal":"Cancers","year":2023,"id":335117,"datarank":0.4566783656585135,"base_score":3.044522437723423,"endowment":3.044522437723423,"self_citation_contribution":0.4566783656585135,"citation_network_contribution":0.0,"self_endowment_contribution":0.4566783656585135,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":20,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9571,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":104270,"name":"Sacha Gnjatic","orcid":"0000-0001-5643-9520","position":1,"is_corresponding":false},{"id":258142,"name":"Carol Aghajanian","orcid":"0000-0003-0851-3225","position":2,"is_corresponding":false},{"id":519279,"name":"Jason Konner","orcid":"0000-0002-0720-2719","position":3,"is_corresponding":false},{"id":315807,"name":"Sarah H. Kim","orcid":null,"position":4,"is_corresponding":false},{"id":478634,"name":"Debra Sarasohn","orcid":"0000-0002-8790-5528","position":5,"is_corresponding":false},{"id":382191,"name":"Krysten Soldan","orcid":null,"position":6,"is_corresponding":false},{"id":233752,"name":"William P. Tew","orcid":"0000-0001-5115-4470","position":7,"is_corresponding":false},{"id":1065070,"name":"Nicholas J. Sarlis","orcid":null,"position":8,"is_corresponding":false},{"id":227533,"name":"Dmitriy Zamarin","orcid":"0000-0002-0094-0161","position":9,"is_corresponding":false},{"id":1065071,"name":"Sara Kravetz","orcid":null,"position":10,"is_corresponding":false},{"id":412914,"name":"Ilaria Laface","orcid":null,"position":11,"is_corresponding":false},{"id":1065072,"name":"Teresa Rasalan-Ho","orcid":null,"position":12,"is_corresponding":false},{"id":810087,"name":"Jingjing Qi","orcid":"0000-0002-9368-1882","position":13,"is_corresponding":false},{"id":245668,"name":"Phillip Wong","orcid":"0000-0002-6360-849X","position":14,"is_corresponding":false},{"id":90775,"name":"Paul Sabbatini","orcid":"0009-0000-8853-2244","position":15,"is_corresponding":false},{"id":256636,"name":"Roisin E. O’Cearbhaill","orcid":"0000-0001-8217-4554","position":16,"is_corresponding":false},{"id":660688,"name":"Beryl Manning‐Geist","orcid":"0000-0002-5556-0457","position":0,"is_corresponding":true}],"reference_count":52,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T01:09:58.338267Z","pmid":"36900251","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}