Clinical trial NCT05061823: Bintrafusp Alfa Program Rollover Study
Official title: An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2021-09-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of Adverse Events and Treatment-Related Adverse Events
timeFrame: Time from first treatment in parent study to planned final assessment at approximately up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Time from first treatment in parent study to planned final assessment at approximately up to 5 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A.
state: Maryland
city: Bethesda
country: United States
facility: NIH National Institutes of Health/GMB LTIB
state: Maryland
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne - PARENT
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
city: Lazio
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary" - PARENT
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
city: Adana
country: Turkey
facility: Adana City Hospital - Parent Account
city: Lutsk
country: Ukraine
facility: Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: