32 Participants Needed

Bintrafusp Alfa Continuation for Cancer

Recruiting at 22 trial locations
UM
CC
Overseen ByCommunication Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: EMD Serono Research & Development Institute, Inc.
Must be taking: Bintrafusp alfa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial offers bintrafusp alfa to patients. The medication helps the immune system fight cancer by blocking proteins that stop it from attacking cancer cells.

Who Is on the Research Team?

MR

Medical Responsible

Principal Investigator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Are You a Good Fit for This Trial?

This trial is for patients already receiving bintrafusp alfa in other studies, without treatment interruption. It's open to those who've had stable disease or controlled side effects after stopping the drug, and are not pregnant nor have severe allergies to its ingredients. Participants must agree to use effective contraception.

Inclusion Criteria

I am currently being treated with bintrafusp alfa, without any breaks.
Participants who have completed End of treatment (EoT) assessment of a parent study
My cancer initially responded to treatment but has now worsened.
See 4 more

Exclusion Criteria

Participants who are pregnant or currently in lactation
Participants with known hypersensitivity to any of the study intervention ingredients
Participants who have withdrawn consent from the parent study for any reason
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous treatment with bintrafusp alfa according to the interval and dosing schedule in the parent protocol until discontinuation

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bintrafusp alfa
Trial Overview The study provides ongoing access to bintrafusp alfa for lung cancer patients from previous trials and collects long-term data on its safety and effectiveness. Treatment continues until set criteria are met, it becomes commercially available, or the study ends.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Bintrafusp alfaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials
86
Recruited
22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials
449
Recruited
122,000+
Danny Bar-Zohar profile image

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo profile image

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security