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The study evaluates MEDI0457, a therapeutic DNA vaccine encoding HPV-16/18 E6 and E7 plasmids with IL-12 adjuvant, combined with the anti-PD-L1 antibody durvalumab. Enrolled participants had recurrent or metastatic, treatment-refractory HPV-16/18 cancers or rare HPV-associated cancers, using defined intramuscular and intravenous dosing. Primary outcome was overall response per RECIST 1.1.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/phase-ii-trial-of-medi0457-and-durvalumab-for-patients-with-recurrentmetastatic-human-papillomavirus-associated-cancers/379014/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/phase-ii-trial-of-medi0457-and-durvalumab-for-patients-with-recurrentmetastatic-human-papillomavirus-associated-cancers/379014.png","ImageObject",300,407,{"name":92,"@type":93},"Jacob","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-28","2026-09-24",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is MEDI0457 and what immune target does it address?","Question",{"text":112,"@type":113},"MEDI0457 is a therapeutic DNA vaccine containing plasmids for HPV-16/18 E6 and E7 oncogenes with an IL-12 adjuvant, designed to provoke an immune response against E6/E7.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Who was eligible for this phase II trial?",{"text":117,"@type":113},"Patients had recurrent or metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated anal or penile cancers, and prior immune checkpoint inhibition was not permitted.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the key efficacy and safety outcomes?",{"text":121,"@type":113},"Overall response rate among evaluable patients was 21%, disease control rate was 37%, median progression-free survival was 4.6 months, and treatment-related grade 3–4 adverse events occurred in 23% of participants.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},379014,1790569705,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":29,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},962084931830,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers  \nVan K. Morris*, 1,, Amir Jazaeri2, Shannon N. Westin2, Curtis Pettaway3, Solly George2, Ryan W. Huey1, Michaela Grinsfelder2, Aaron Shafer2, Benny Johnson1,, David Vining4, Ming Guo5,, Bryan Fellman6, Michael Frumovitz2  \n1Department of Gastrointestinal Medical Oncology, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA  \n2Department of Gynecologic Oncology, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA 3Department of Urology, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA 4Department of Radiology, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA 5Department of Pathology, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA 6Department of Biostatistics, The University of Texas – MD Anderson Cancer Center, Houston, TX, USA  \n*Corresponding author: Van K. Morris, MD, Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Holcombe Blvd., Houston, TX 77030, USA. Tel: +1 713 792 2828; [Email:](Email: vkmorris@mdanderson.org)[ vkmorris@mdanderson.org](Email: vkmorris@mdanderson.org)  \nAbstract  \nBackground: Human papillomavirus (HPV) types 16/18 drive oncogenesis for most patients with cervical, anal, and penile cancers . MEDI0457, a therapeutic DNA vaccine containing plasmids for E6 and E7 HPV-16/18 viral oncogenes and IL-12 adjuvant, is safe and provokes an immune response against E6/E7. We tested MEDI0457 with the anti-PD-L1 antibody durvalumab for patients with HPV-associated cancers .  \nMethods: Patients with recurrent/metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated (anal and penile) cancers were eligible. Prior immune checkpoint inhibition was not permitted. Patients received MEDI0457 7 mg intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks. The primary endpoint was overall response (RECIST 1. 1) . In this Simon two-stage phase 2 trial (Ho: p \u003C 0.15; Ha: p ≥ 0.35), ≥2 responses were needed in both cervical and non-cervical cohorts during the first stage for the trial to proceed to stage 2 with an additional 25 patients (34 total) enrolled.  \nResults: Twenty-one patients (12 cervical, 7 anal, and 2 penile) were evaluable for toxicity and 19 for response Overall response rate was 21%(95% CI, 6%-46%) among evaluable patients. Disease control rate was 37%(95% CI, 16%-62%) . Median duration of response among responders was 21.8 months (95% CI, 9. 7%-not estimable) . Median progression-free survival was 4.6 months (95% CI, 2. 8%-7. 2%) . Median overall survival was 17.7 months (95% CI, 7. 6%-not estimable) . Grades 3-4 treatment-related adverse events occurred in 6 (23%) participants.  \nConclusions: The combination of MEDI0457 and durvalumab demonstrated acceptable safety and tolerability in patients with advanced HPV- 16/18 cancers. The low ORR among patients with cervical cancer led to study discontinuation despite a clinically meaningful disease control rate.  \nKey words: immunotherapy; anti-PD-L1; metastasis; HPV; DNA vaccine.  \nImplications for Practice  \nInfection with human papillomavirus drives oncogenesis in the majority of cervical, anal, and penile cancers. Anti-tumor activity with anti-PD-(L)1 antibodies as monotherapy in patients with advanced HPV-associated cancers is modest. This study demonstrated prolonged disease control using combination immunotherapy with a therapeutic HPV-16/HPV-18 DNA vaccine and IL-12 adjuvant in some patients with advanced HPV-associated anogenital malignancies. A minority of patients with HPV-associated cancers experienced durable clinical benefits with durvalumab and MEDI0457 that exceeded one year. Further understanding of immune signatures associated with response to immunotherapy combinations may direct precision app","cbCais37aWOUVpbN","https://ap.wps.com/l/cbCais37aWOUVpbN","pdf",1034072,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusions\n## Implications for Practice\n# Introduction","[{\"question\":\"What is MEDI0457 and what immune target does it address?\",\"answer\":\"MEDI0457 is a therapeutic DNA vaccine containing plasmids for HPV-16/18 E6 and E7 oncogenes with an IL-12 adjuvant, designed to provoke an immune response against E6/E7.\"},{\"question\":\"Who was eligible for this phase II trial?\",\"answer\":\"Patients had recurrent or metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated anal or penile cancers, and prior immune checkpoint inhibition was not permitted.\"},{\"question\":\"What were the key efficacy and safety outcomes?\",\"answer\":\"Overall response rate among evaluable patients was 21%, disease control rate was 37%, median progression-free survival was 4.6 months, and treatment-related grade 3–4 adverse events occurred in 23% of participants.\"}]","Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers | PDF",1790233688,15]