Lung CancerPhase 3NCT05061823
Bintrafusp Alfa Program Rollover Study
A Phase 3 study testing Bintrafusp alfa in people with Lung Cancer and Cancer, run by EMD Serono Research & Development Institute, Inc. at 21 sites in 12 countries.
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, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Cancer
- What is being tested?
- Bintrafusp alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 21 sitesin 12 countries
- Study dates
- 1 Dec 2021to 21 Mar 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 12 countries.
21 sites in 12 countries
South Korea4 sites
Gachon University Gil Medical Center
Incheon
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Japan3 sites
National Cancer Center Hospital
Chūōku
Saitama Medical University International Medical Center
Hidaka-shi
National Cancer Center Hospital East
Kashiwa-shi
Spain3 sites
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia
United States2 sites
The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A.
Bethesda, Maryland, 20817
NIH National Institutes of Health/GMB LTIB
Bethesda, Maryland, 20892
Taiwan2 sites
Taichung Veterans General Hospital
Taichung
Chang Gung Memorial Hospital,Linkou
Taoyuan County
Germany1 site
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Lazio
Ukraine1 site
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy
Lutsk
About this study
Official title: 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, 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.
Read more
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
- Being tested
- Bintrafusp alfa
- 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
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bintrafusp alfaDrug
Also called M7824
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.
| Study group | Role | What they receive |
|---|---|---|
| Bintrafusp alfa | Experimental | Not described Receives: Drug: Bintrafusp alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OS was defined as the time from study day 1 in parent study to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Dec 2021
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061823
- Sponsor's protocol ID
- MS200647_0054
- Other IDs
- 2021-000179-36
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2021
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies
- ClinicalTrials.gov ID
- NCT05061823
- Acronym / sponsor ID
- MS200647_0054
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bintrafusp alfa | Experimental | Drug: Bintrafusp alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bintrafusp alfaAlso: M7824Participants 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. | Drug | Bintrafusp alfa |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs)
Time frame: 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)
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.
1 secondary outcome
Overall Survival (OS)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
21 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bintrafusp alfa in people with Lung Cancer and Cancer, run by EMD Serono Research & Development Institute, Inc. at 21 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea, Japan, Spain, United States, Taiwan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.