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NCT05061823 · ClinicalTrials.gov registry record · Phase 3
Bintrafusp Alfa Program Rollover Study
A Phase 3 study of Cancer and Lung Cancer, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 22
- Enrollment target
- 20
- Study locations
NCT05061823 is a Phase 3 study of Cancer and Lung Cancer that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 22 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 2 states.
The verdict
NCT05061823, a Phase 3 study of Cancer and Lung Cancer, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 22 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
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.
NCT05061823 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, Maryland.
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.
What interventions are being tested in trial NCT05061823?
The interventions under investigation include: Bintrafusp alfa (DRUG).
Who is sponsoring clinical trial NCT05061823?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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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