Bintrafusp Alfa Continuation for Cancer

No longer recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on continuing treatment with bintrafusp alfa for individuals from previous related studies. The goal is to gather long-term data on the safety and effectiveness of this cancer treatment. It targets those who have shown a positive response or maintained a stable condition with bintrafusp alfa and wish to continue therapy. Individuals from earlier studies who have not received other cancer treatments since stopping bintrafusp alfa might be suitable candidates. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to the validation of a promising cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are reinitiating treatment with bintrafusp alfa, you should not have received any systemic anticancer therapies since discontinuing it.

Is there any evidence suggesting that bintrafusp alfa is likely to be safe for humans?

Research has shown that bintrafusp alfa is generally well-tolerated. In one study, patients with advanced lung cancer experienced promising results, with effective treatment and manageable side effects. Another study found that bintrafusp alfa caused important changes in the immune system, aiding in cancer defense while controlling side effects.

Other research indicates that patients with head and neck cancer tolerated the treatment well, even after trying other treatments. This suggests that bintrafusp alfa is safe for various cancer types, with manageable side effects. Overall, these findings suggest that bintrafusp alfa is a promising treatment option with an acceptable safety profile in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer?

Bintrafusp alfa is unique because it combines two different mechanisms into one treatment, targeting both the PD-L1 protein and TGF-β pathways. Unlike traditional cancer therapies that focus on just one of these pathways, bintrafusp alfa aims to tackle cancer growth and immune evasion simultaneously. Researchers are excited about this dual-action approach because it holds the potential to enhance the immune system's ability to fight cancer more effectively than existing treatments, potentially leading to better outcomes for patients.

What evidence suggests that bintrafusp alfa might be an effective treatment for cancer?

Research has shown that bintrafusp alfa, the treatment under study in this trial, could help treat certain cancers. Specifically, in patients with non-small cell lung cancer (NSCLC), 21.3% experienced tumor shrinkage. In another study involving cervical cancer patients, 13% had a lasting positive response for six months or more. Additionally, when combined with chemotherapy for advanced cancer, bintrafusp alfa proved safe and showed promising results. These findings suggest that bintrafusp alfa might be effective for some cancer patients. ^{1 4 6 7 8}

Who Is on the Research Team?

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.

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 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?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39717667/

Efficacy and Safety of Bintrafusp Alfa, a Bifunctional Fusion ... Bintrafusp alfa with chemotherapy was found to have a manageable safety profile and encouraging clinical activity in patients with stage IV ...

2. jitc.bmj.com jitc.bmj.com/content/12/3/e008480

Efficacy, safety, and biomarker analyses of bintrafusp alfa ... In an NSCLC expansion cohort of the phase 1 study, bintrafusp alfa showed clinical activity (overall response rate [ORR], 21.3% and median ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0169500225004374

Efficacy and safety of bintrafusp alfa evaluated in a phase II ... For second-line bintrafusp alfa, the estimated PFS rate at 6 months: 18.5 % (95 % CI: 8.1–32.1 %), at 12 months: 5.3 % (95 % CI: 0.9–15.6 %), and at 18 months: ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2821597

Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer ... A DRR of 6 months or more was reported in 19 of 146 patients (13.0%; 95% CI, 8.0-19.6) and in 19 of 32 patients (59.4%) who achieved an ...

5. jtocrr.org jtocrr.org/article/S2666-3643(24)00118-8/fulltext

Efficacy and Safety of Bintrafusp Alfa, a Bifunctional Fusion ... In a phase 1 study, bintrafusp alfa was found to have an encouraging clinical activity in patients with previously treated advanced NSCLC.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38485188/

Efficacy, safety, and biomarker analyses of bintrafusp alfa, a ... Bintrafusp alfa was observed to have modest clinical activity and manageable safety, and was associated with notable immunologic changes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666364324001188

Efficacy and Safety of Bintrafusp Alfa, a Bifunctional Fusion ... In a phase 1 study, bintrafusp alfa was found to have an encouraging clinical activity in patients with previously treated advanced NSCLC.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10493598/

Efficacy, safety, and correlative biomarkers of bintrafusp ... A phase I study showed that bintrafusp alfa is efficacious and safe in heavily pre-treated squamous cell carcinoma of head and neck cancer.