Bintrafusp Alfa Program Rollover Study

An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies

This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Lung Cancer
• Intervention / Treatment: Drug: Bintrafusp alfa

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Libramont, Belgium
    • Centre Hospitalier de l'Ardenne - PARENT
• China
  • Harbin, China
    • Harbin Medical University Cancer Hospital
• Germany
  • Dresden, Germany
    • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
• Italy
  • Lazio, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
• Japan
  • Chuo-ku, Japan
    • National Cancer Center Hospital
  • Hidaka-shi, Japan
    • Saitama Medical University International Medical Center
  • Kashiwa-shi, Japan
    • National Cancer Center Hospital East
• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
• Russian Federation
  • Omsk, Russian Federation
    • BHI of Omsk region "Clinical Oncology Dispensary" - PARENT
• Spain
  • Madrid, Spain
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal - Servicio de Oncologia
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taoyuan County, Taiwan
    • Chang Gung Memorial Hospital,Linkou
• Turkey
  • Adana, Turkey
    • Adana City Hospital - Parent Account
• Ukraine
  • Lutsk, Ukraine
    • Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A.
    • Bethesda, Maryland, United States, 20892
      • NIH National Institutes of Health/GMB LTIB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bintrafusp alfa

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.; Other Names: M7824

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Adverse Events and Treatment-Related Adverse Events	Time from first treatment in parent study to planned final assessment at approximately up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Time from first treatment in parent study to planned final assessment at approximately up to 5 years

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): April 3, 2025
• Study Completion (Estimated): April 3, 2025

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Solid Tumors; Bintrafusp alfa; Tumor response; Performance Status; 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
• Other Study ID Numbers: MS200647_0054; 2021-000179-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No