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Cancer drug bintrafusp alfa gets Long-Term safety check in small Follow-Up trial

NCT ID NCT05061823

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 22 cancer patients who were already taking bintrafusp alfa in earlier trials, to see how safe it is over the long term and how long they live. Participants continued receiving the drug until it was no longer helping or became available commercially. The main goal was to track side effects, and researchers also looked at overall survival. It's a small, completed Phase 3 rollover study, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bintrafusp alfa (M7824)
What this could lead to
If successful, this study could confirm that long-term use of bintrafusp alfa is safe and helps control cancer over time.
What could go wrong
This is a small rollover study with only 22 participants, so results may not apply broadly. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

22 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer lung cancer lung neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Lung cancer

Contacts and locations

Locations

  • Adana City Hospital - Parent Account

    Adana, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, South Korea

  • BHI of Omsk region "Clinical Oncology Dispensary" - PARENT

    Omsk, Russia

  • Centre Hospitalier de l'Ardenne - PARENT

    Libramont, Belgium

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan County, Taiwan

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

    Lutsk, Ukraine

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Lazio, Italy

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Harbin Medical University Cancer Hospital

    Harbin, China

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

    Valencia, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid, Spain

  • NIH National Institutes of Health/GMB LTIB

    Bethesda, Maryland, 20892, United States

  • National Cancer Center Hospital

    Chūōku, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Japan

  • Saitama Medical University International Medical Center

    Hidaka-shi, Japan

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Taichung Veterans General Hospital

    Taichung, Taiwan

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

    Bethesda, Maryland, 20817, United States

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

    Dresden, Germany

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