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An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
22
12 countries
21
Study Start
December 1, 2021
Actual (reported)Primary Completion
March 21, 2025
Actual (reported)Study Completion
March 21, 2025
Actual (reported)This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 21, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2021
Actual (reported)September 30, 2021
Actual (reported)December 1, 2021
Actual (reported)March 21, 2025
Actual (reported)March 21, 2025
Actual (reported)February 2, 2026
Actual (reported)Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment.
Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)
Overall Survival (OS)
Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)
Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A.
Bethesda, Maryland, 20817, United States
NIH National Institutes of Health/GMB LTIB
Bethesda, Maryland, 20892, 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
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
22 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2021
First Posted
September 30, 2021
Study Start
December 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Chūōku, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Japan
National Cancer Center Hospital East
Kashiwa-shi, Japan
BHI of Omsk region "Clinical Oncology Dispensary" - PARENT
Omsk, Russia
Gachon University Gil Medical Center
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
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 (Türkiye)
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy
Lutsk, Ukraine
Primary Completion
March 21, 2025
Actual (reported)Study Completion
March 21, 2025
Actual (reported)Last Updated
February 2, 2026
Results First Posted
February 2, 2026
Record last verified: 2026-01
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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