Bintrafusp Alfa Program Rollover Study

NCT ID: NCT05061823

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-03-21

Brief 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

Lung Cancer; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bintrafusp alfa

Group Type: EXPERIMENTAL

Bintrafusp alfa

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

M7824

Eligibility Criteria

Inclusion Criteria

• Participants who are currently enrolled in an eligible bintrafusp alfa parent study where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed
• Participants who are currently on active bintrafusp alfa treatment alone as a monotherapy or following discontinuation of other combination treatment agents in the parent study and without treatment interruption at the time of rollover study enrollment
• Participants who experienced a confirmed complete response (CR), partial response (PR), or stable disease (SD) in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants' physicians
• Participants who are.discontinued from bintrafusp alfa treatment in an eligible parent study due to an adverse events (AEs) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants' physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain immune-related adverse events (irAEs) or certain bleeding events are excluded from participation in this Rollover study
• Participants with only SD at the time of discontinuation, the Investigator should confirm that no other reasonable treatment options are available
• Participants who have completed End of treatment (EoT) assessment of a parent study
• The investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable. The contraception, barrier, and pregnancy testing requirements are below:
• For female participants of childbearing potential or for male participants who have female partners of childbearing potential, the following applies:
• Participants on active treatment must agree to continue to use highly effective contraception for both male and female participants if the risk of conception exists thus, women of childbearing potential and men must agree to use highly effective contraception as stipulated in national or local guidelines
• Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 2 months (for female participants) or 4 months (for male participants) after stopping study intervention
• Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately

Exclusion Criteria

• Participants who are pregnant or currently in lactation
• Participants with known hypersensitivity to any of the study intervention ingredients.
• Participants reinitiating treatment with bintrafusp alfa at study entry: have received any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa treatment.
• Participants who has withdrawn consent from the parent study for any reason
• Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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

Bethesda, Maryland, United States

NIH National Institutes of Health/GMB LTIB

Bethesda, Maryland, United States

Centre Hospitalier de l'Ardenne - PARENT

Libramont, , Belgium

Harbin Medical University Cancer Hospital

Harbin, , China

Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

Dresden, , Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Lazio, , Italy

National Cancer Center Hospital

Chūōku, , Japan

Saitama Medical University International Medical Center

Hidaka-shi, , Japan

National Cancer Center Hospital East

Kashiwa-shi, , Japan

BHI of Omsk region "Clinical Oncology Dispensary" - PARENT

Omsk, , Russia

Gachon University Gil Medical Center

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, , Spain

Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

Valencia, , Spain

Taichung Veterans General Hospital

Taichung, , Taiwan

Chang Gung Memorial Hospital,Linkou

Taoyuan, , Taiwan

Adana City Hospital - Parent Account

Adana, , Turkey (Türkiye)

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

Lutsk, , Ukraine

Countries

United States; Belgium; China; Germany; Italy; Japan; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200647_0054

Trial Awareness and Transparency website

https://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

Other Identifiers

MS200647_0054

Identifier Type: -

Identifier Source: org_study_id

2021-000179-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id