Bintrafusp Alfa Program Rollover Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05061823
• Other study ID #: MS200647_0054
• Secondary ID: 2021-000179-36
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: April 3, 2025

Study information

• Verified date: March 2024
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 3, 2025
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Lung Cancer

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Belgium,  China,  Germany,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)		Time from first treatment in parent study to planned final assessment at approximately up to 5 years

External Links

•   Trial Awareness and Transparency website