Bintrafusp Alfa Program Rollover Study

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

March 21, 2025

Study Completion Date

March 21, 2025

Conditions
Lung CancerCancer
Interventions
DRUG

Bintrafusp alfa

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) per 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.

Trial Locations (21)

20817

The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A., Bethesda

20892

NIH National Institutes of Health/GMB LTIB, Bethesda

Unknown

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

Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy, Lutsk

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT05061823 - Bintrafusp Alfa Program Rollover Study | Biotech Hunter | Biotech Hunter