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Bintrafusp Alfa Program Rollover Study
NCT05061823 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Bintrafusp alfa
Study Locations (20)
Other
- Centre Hospitalier de l'Ardenne - PARENT — Libramont
- Harbin Medical University Cancer Hospital — Harbin
- Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I — Dresden
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica — Lazio
- National Cancer Center Hospital — Chūōku
- Saitama Medical University International Medical Center — Hidaka-shi
- National Cancer Center Hospital East — Kashiwa-shi
- BHI of Omsk region "Clinical Oncology Dispensary" - PARENT — Omsk
- Gachon University Gil Medical Center — Incheon
- Asan Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Severance Hospital, Yonsei University Health System — Seoul
- Hospital General Universitario Gregorio Marañón — Madrid
- Hospital Universitario Ramon y Cajal - Servicio de Oncologia — Madrid
- Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica — Valencia
- Taichung Veterans General Hospital — Taichung
- Chang Gung Memorial Hospital,Linkou — Taoyuan
- Adana City Hospital - Parent Account — Adana
Maryland
- The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A. — Bethesda
- NIH National Institutes of Health/GMB LTIB — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2025-03-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05061823
The ClinicalTrials.gov registry entry for NCT05061823 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which Bintrafusp alfa is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05061823 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05061823 about?
NCT05061823 is a clinical study titled "Bintrafusp Alfa Program Rollover Study". 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 ...
What is the current status of trial NCT05061823?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2021-12-01. Estimated completion is 2025-03-21.
What conditions does trial NCT05061823 study?
This clinical trial studies the following conditions: Cancer, Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05061823?
The interventions under investigation include: Bintrafusp alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05061823?
This trial is sponsored by EMD Serono Research & Development Institute, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05061823 being conducted?
This trial has 20 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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