Bintrafusp Alfa Program Rollover Study

NCT05061823 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MS200647_00542021-000179-36
• Study Type: interventional
• Target: 22
• Locations: 12 countries
• Sites: 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

Keywords

Solid Tumors; Tumor response; Safety; Efficacy; Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1); Programmed death ligand 1; Survival Follow-up; Human transforming growth factor β (TGFβ) receptor II; Performance Status; Bintrafusp alfa

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment.

  Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)

Secondary Outcomes (1)

• Overall Survival (OS)

  Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days)

Study Arms (1)

Bintrafusp alfa

EXPERIMENTAL

Drug: Bintrafusp alfa

Interventions

Bintrafusp alfa 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) 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.

Also known as: M7824

Bintrafusp alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (21)

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

Bethesda, Maryland, 20817, United States

Location

NIH National Institutes of Health/GMB LTIB

Bethesda, Maryland, 20892, United States

Location

Centre Hospitalier de l'Ardenne - PARENT

Libramont, Belgium

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

Dresden, Germany

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Lazio, Italy

Location

National Cancer Center Hospital

Chūōku, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Japan

Location

BHI of Omsk region "Clinical Oncology Dispensary" - PARENT

Omsk, Russia

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, Spain

Location

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

Valencia, Spain

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Chang Gung Memorial Hospital,Linkou

Taoyuan, Taiwan

Location

Adana City Hospital - Parent Account

Adana, Turkey (Türkiye)

Location

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

Lutsk, Ukraine

Location

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

bintrafusp alfa protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: December 1, 2021
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

TU (1); UA (1); RU (1); ES (3); CN (1); IT (1); US (2); BE (1); JP (3); KR (4); DE (1); TW (2)