KeyNote-587

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

{ "short_title": "KeyNote-587", "data_mode": "900", "data_mode_number": "000002091", "official_title": "A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "first", "ctgov_number": "NCT03486873", "eudract_number": "2017-004417-42", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Ziel dieser Studie ist es, die Langzeitsicherheit und -wirksamkeit von Pembrolizumab (MK-3475) bei Teilnehmern aus fr\u00fcheren, auf Pembrolizumab basierenden Elternstudien von Merck zu untersuchen, die in diese Erweiterungsstudie \u00fcberwechseln. Diese Studie wird aus drei Phasen bestehen: 1) Erste Kursphase, 2) \u00dcberlebens-Follow-up-Phase oder 3) Zweite Kursphase. Jeder Teilnehmer wird in einer der folgenden drei Phasen in diese Erweiterungsstudie \u00fcbergehen, je nachdem, in welcher Studienphase er sich zum Zeitpunkt des Abschlusses der Elternstudie befand. Teilnehmer, die sich in der First-Course-Phase der Studienbehandlung in der Mutterstudie befanden, treten in die First-Course-Phase dieser Studie ein und absolvieren bis zu 35 Dosen oder mehr alle 3 Wochen (Q3W) oder 17 Dosen oder mehr alle 6 Wochen (Q6W) der Studienbehandlung mit Pembrolizumab oder einer Pembrolizumab-basierten Kombination entsprechend der Armzuweisung.", "description_laie_en": "The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.", "description_expert_de": "Ziel dieser Studie ist es, die Langzeitsicherheit und -wirksamkeit von Pembrolizumab (MK-3475) bei Teilnehmern aus fr\u00fcheren, auf Pembrolizumab basierenden Elternstudien von Merck zu untersuchen, die in diese Erweiterungsstudie \u00fcberwechseln. Diese Studie wird aus drei Phasen bestehen: 1) Erste Kursphase, 2) \u00dcberlebens-Follow-up-Phase oder 3) Zweite Kursphase. Jeder Teilnehmer wird in einer der folgenden drei Phasen in diese Erweiterungsstudie \u00fcbergehen, je nachdem, in welcher Studienphase er sich zum Zeitpunkt des Abschlusses der Elternstudie befand. Teilnehmer, die sich in der First-Course-Phase der Studienbehandlung in der Mutterstudie befanden, treten in die First-Course-Phase dieser Studie ein und absolvieren bis zu 35 Dosen oder mehr alle 3 Wochen (Q3W) oder 17 Dosen oder mehr alle 6 Wochen (Q6W) der Studienbehandlung mit Pembrolizumab oder einer Pembrolizumab-basierten Kombination entsprechend der Armzuweisung.", "description_expert_en": "The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 3, "sub_cat_id": 16 }