Spots Global Cancer Trial Database for Bintrafusp Alfa Program Rollover Study
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Trial Identification
Brief Title: Bintrafusp Alfa Program Rollover Study
Official Title: An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies
Study ID: NCT05061823
Interventions
Study Description
Brief Summary: This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study. The study also includes a 5 years survival follow-up after last dose of the study treatment. Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A., Bethesda, Maryland, United States
NIH National Institutes of Health/GMB LTIB, Bethesda, Maryland, United States
Centre Hospitalier de l'Ardenne - PARENT, Libramont, , Belgium
Harbin Medical University Cancer Hospital, Harbin, , China
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I, Dresden, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica, Lazio, , Italy
National Cancer Center Hospital, Chuo-ku, , Japan
Saitama Medical University International Medical Center, Hidaka-shi, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
BHI of Omsk region "Clinical Oncology Dispensary" - PARENT, Omsk, , Russian Federation
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
Chang Gung Memorial Hospital,Linkou, Taoyuan County, , Taiwan
Adana City Hospital - Parent Account, Adana, , Turkey
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy, Lutsk, , Ukraine
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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