V940-005

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

{ "short_title": "V940-005", "data_mode": "900", "data_mode_number": "000002309", "official_title": "A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT06305767", "eudract_number": "2023-505658-17", "general_contact_email": null, "general_contact_phone": null, "hauptpruefer_dd_name": "Dr. med. Angelika Borkowetz", "description_laie_de": "Alternativtherapie mit V940 + Pembrolizumab versus Placebo + Pembrolizumab (aktueller Standard)", "description_laie_en": "Testing of an alternative therapy with V940 + pembrolizumab versus placebo + pembrolizumab (previous standard)", "description_expert_de": "Ziel dieser Studie ist es, die Sicherheit und Wirksamkeit von V940 in Kombination mit Pembrolizumab (MK-3475) im Vergleich zu Pembrolizumab allein als adjuvante Behandlung f\u00fcr Teilnehmer mit pathologischem muskelinvasivem Urothelkarzinom (MIUC) mit hohem Risiko nach radikaler Resektion zu untersuchen. Die prim\u00e4re Studienhypothese ist, dass V940 in Kombination mit Pembrolizumab bei Teilnehmern mit Hochrisiko-MIUC nach radikaler Resektion zu einem besseren krankheitsfreien \u00dcberleben (DFS) f\u00fchrt als Pembrolizumab allein.", "description_expert_en": "The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 11, "sub_cat_id": 52 }