Bintrafusp Alfa Program Rollover 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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2025-03-21
- Completion
- 2025-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bintrafusp alfa | Protein / enzyme biologic | 1200 mg | Intravenous |
| Subject | Bintrafusp alfa | Protein / enzyme biologic | 2400 mg | Intravenous |