Bintrafusp Alfa Continuation for Cancer

Recruiting at 22 trial locations

Overseen By Communication Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EMD Serono Research & Development Institute, Inc.

Must be taking: Bintrafusp alfa

Must not be taking: Systemic anticancer therapies

Disqualifiers: Pregnancy, Lactation, Hypersensitivity, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

32 Participants Needed

Trial Summary

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.

Research Team

Medical Responsible

Principal Investigator

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

Eligibility Criteria

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.

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Participants who have withdrawn consent from the parent study for any reason

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Bintrafusp alfa Experimental Treatment 1 Intervention

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

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD