GLORIOSA

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRa). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRa positivity by the Ventana FOLR1 Assay.

{ "short_title": "GLORIOSA", "data_mode": "900", "data_mode_number": "000002430", "official_title": "Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRa-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA)", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "gtThird", "ctgov_number": "NCT05445778", "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Mirvetuximab Soravtansine (MIRV) ist ein Antik\u00f6rper-Wirkstoff-Konjugat in der klinischen Entwicklung, das gezielt Krebszellen abt\u00f6tet. Der Antik\u00f6rper (Protein) von MIRV zielt auf Tumore ab, indem er ein zellt\u00f6tendes Medikament an die Tumorzellen liefert, die ein tumorassoziiertes Protein namens Folatrezeptor Alpha (FRa) tragen. Es wird als Erhaltungstherapie f\u00fcr die Behandlung von Patienten mit rezidiviertem platinsensitivem, hochgradigem epithelialem Eierstockkrebs, prim\u00e4rem Peritonealkarzinom oder Eileiterkrebs mit hoher Folatrezeptor-Alpha-Expression entwickelt. Patienten m\u00fcssen FRa-positiv durch den Ventana FOLR1-Test best\u00e4tigt bekommen.", "description_laie_en": "Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRa). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRa positivity by the Ventana FOLR1 Assay.", "description_expert_de": "Mirvetuximab Soravtansine (MIRV) ist ein Antik\u00f6rper-Wirkstoff-Konjugat in der klinischen Entwicklung, das gezielt Krebszellen abt\u00f6tet. Der Antik\u00f6rper (Protein) von MIRV zielt auf Tumore ab, indem er ein zellt\u00f6tendes Medikament an die Tumorzellen liefert, die ein tumorassoziiertes Protein namens Folatrezeptor Alpha (FRa) tragen. Es wird als Erhaltungstherapie f\u00fcr die Behandlung von Patienten mit rezidiviertem platinsensitivem, hochgradigem epithelialem Eierstockkrebs, prim\u00e4rem Peritonealkarzinom oder Eileiterkrebs mit hoher Folatrezeptor-Alpha-Expression entwickelt. Patienten m\u00fcssen FRa-positiv durch den Ventana FOLR1-Test best\u00e4tigt bekommen.", "description_expert_en": "Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRa). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRa positivity by the Ventana FOLR1 Assay.", "rechtsgrundlage_value": "MPG", "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 15 }