drugset / Trial / NCT05061823

Bintrafusp Alfa Program Rollover Study

NCT05061823

NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
Subject Bintrafusp alfa Protein / enzyme biologic 1200 mg Intravenous
Subject Bintrafusp alfa Protein / enzyme biologic 2400 mg Intravenous

Indications