[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-337032-105":59,"doc-detail-337032-en":131},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":124,"head_meta":126,"extra_data":128,"updated_unix":130},105,"en","clinical-trial-protocol-tedova-vaccine-ose2101-pembrolizumab-as-maintenance","CLINICAL TRIAL PROTOCOL - TEDOVA - vaccine OSE2101 +/-pembrolizumab as maintenance","","Ovarian cancer is a leading cause of death among gynecological cancers worldwide. Platinum-based chemotherapy forms the cornerstone of care, while maintenance strategies are used after first-line treatment and subsequent relapses to prolong time between chemotherapy lines. Standard maintenance options include bevacizumab and PARP inhibitors, yet they can be used only once during the disease course, creating unmet need in platinum-sensitive relapses after prior exposure. TEDOVA is an academic-sponsored international Phase II randomized trial testing OSE2101 vaccine plus pembrolizumab as maintenance after platinum-based chemotherapy with no progression.",{"@graph":69,"@context":123},[70,84,106],{"@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/clinical-trial-protocol-tedova-vaccine-ose2101-pembrolizumab-as-maintenance/337032/",{"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/clinical-trial-protocol-tedova-vaccine-ose2101-pembrolizumab-as-maintenance/337032.png","ImageObject",300,407,{"name":92,"@type":93},"Quinn","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-21",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is the main goal of the TEDOVA Phase II trial?","Question",{"text":113,"@type":114},"To evaluate whether combining the OSE2101 vaccine with pembrolizumab can better control platinum-sensitive recurrent ovarian cancer and ensure the safety of the treatments.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"Which maintenance therapies are being compared in this study?",{"text":118,"@type":114},"Patients are randomized to standard supportive care, OSE2101 vaccine alone, or the combination of OSE2101 plus pembrolizumab as maintenance.",{"name":120,"@type":111,"acceptedAnswer":121},"Why is there an unmet medical need addressed by TEDOVA?",{"text":122,"@type":114},"Approved maintenance options such as bevacizumab and PARP inhibitors can only be used once in the disease course, leaving no approved options to maintain control after patients have already received both.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},337032,1790204196,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":52,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},962075114765,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","CLINICAL TRIAL PROTOCOL     \nTEDOVA: vaccine OSE2101 +/-pembrolizumab as maintenance in platinum-sensitive recurrent ovarian cancer  \nRayan Kabiriana, Olivier Tredanb, Frederik Marméc, Xavier Paolettid, Lauriane Eberste, Coriolan Lebretonf, Thibault De La Motte Rougeg, Renaud Sabatierh, Antoine Angelerguesi, Michel Fabbroj, Toon Van Gorpk, Laura Mansil, Laurence Gladieffm, Emilie Kaczmarekn, Jérôme Alexandreo, Thomas Grelletyp, Laure Favierq, Julia Welzr, Jean-Sébastien Frenels and Alexandra Leary* , a  \na Department of Medical Oncology, Gustave Roussy, Villejuif, & GINECO, France; bCentre Léon Bérard, Lyon, & GINECO, France;  \nc Medical Faculty Mannheim, Heidelberg University & AGO Study Group, Germany; d Biostatistic Unit, Institut Curie, Paris, France; e Institut de Cancérologie de Strasbourg Europe, ICANS, Strasbourg, & GINECO, France; f Institut Bergonié, Bordeaux, & GINECO, France; gCentre Eugène Marquis, Rennes, & GINECO, France; hAix-Marseille Univ, CRCM, Inserm, CNRS, Institut Paoli-Calmettes, Department of Medical Oncology, Marseille, & GINECO, France; i Groupe Hospitalier Diaconesses-Croix Saint-Simon, Paris, & GINECO, France; j Institut du Cancer de Montpellier (ICM), Montpellier, & GINECO, France; k Leuven Cancer Institute, Division of Gynaecological Oncology, University Hospital Leuven, BGOG, Belgium; lCHU Besançon – Hôpital jean Minjoz, Besançon, & GINECO, France; mOncopole Claudius Regaud, IUCT-Oncopole, Toulouse, & GINECO, France; n Centre Oscar Lambret, Lille, & GINECO, France; o Université de Paris Cité, AP-HP, Hôpital Cochin, Paris, & GINECO, France; p Centre Hospitalier de la Côte Basque, Bayonne, & GINECO, France; q Centre Georges François Leclerc, Dijon, & GINECO, France; r Evang. Kliniken Essen-Mitte-ESSEN & AGO Study Group, Germany; s Institut de Cancérologie de l’Ouest, Centre René Gauducheau, 44800, Saint Herblain, & GINECO, France  \nABSTRACT  \nOvarian cancer is a leading cause of death from gynecological cancers worldwide. Platinum-based chemotherapy provides the cornerstone of the medical management. In first line and subsequent relapses, maintenance strategies are offered to prolong intervals between lines of chemotherapy. Current maintenance options involve bevacizumab and poly ADP-ribose polymerase inhibitors, but these lines of therapy can only be used once in the disease course. Patients in first or second platinum sensitive relapse after poly ADP-ribose polymerase inhibitors and bevacizumab represent an area ofunmet medical need. This academic sponsored, international Phase II randomized trial is evaluating the combination of a therapeutic cancer vaccine (OSE2101) with anti-PD1 (pembrolizumab) as maintenance therapy, in patients with platinum-sensitive recurrence regardless of number of prior lines and no progression after platinum-based chemotherapy.  \nClinical Trial Registration: NCT04713514 ([ClinicalTrials.gov](ClinicalTrials.gov))  \nTWEETABLE ABSTRACT  \nOngoing Phase II study randomizing vaccine OSE2101 +/ - Pembrolizumab vs supportive care as maintenance in platinum-sensitive recurrent ovarian cancer.  \nPLAIN LANGUAGE SUMMARY  \nPhase II study evaluating vaccine OSE2101 +/ -Pembrolizumab vs supportive care as maintenance in patients with recurrent platinum-sensitive ovarian cancer.  \nOvarian cancer often becomes a long-term condition that needs ongoing treatment. After chemotherapy, women usually receive additional treatments to keep the cancer under control. There are only two approved treatments for this: bevacizumab administered every 3 weeks, and poly ADPribose polymerase inhibitors (PARP) inhibitors, which are pills that women can take if their cancer responds to platinum-based chemotherapy. However, if women have already been treated with both bevacizumab and a PARP inhibitor, there are no approved options left to maintain control of the cancer after chemotherapy.  \nA new potential treatment, called OSE2101, is being studied: it is a vaccine designed to activate the body’s immune c","cbCaia26LXM7otn2","https://ap.wps.com/l/cbCaia26LXM7otn2","pdf",1150839,"English","# Abstract\n# Clinical trial design and objectives\n## Study groups and randomization\n# Patient eligibility and current context\n## Prior bevacizumab and PARP inhibitor exposure\n# Registration, summary, and key terms","[{\"question\":\"What is the main goal of the TEDOVA Phase II trial?\",\"answer\":\"To evaluate whether combining the OSE2101 vaccine with pembrolizumab can better control platinum-sensitive recurrent ovarian cancer and ensure the safety of the treatments.\"},{\"question\":\"Which maintenance therapies are being compared in this study?\",\"answer\":\"Patients are randomized to standard supportive care, OSE2101 vaccine alone, or the combination of OSE2101 plus pembrolizumab as maintenance.\"},{\"question\":\"Why is there an unmet medical need addressed by TEDOVA?\",\"answer\":\"Approved maintenance options such as bevacizumab and PARP inhibitors can only be used once in the disease course, leaving no approved options to maintain control after patients have already received both.\"}]","CLINICAL TRIAL PROTOCOL - TEDOVA - vaccine OSE2101 +/-pembrolizumab as maintenance | PDF",1790017459,25]