What side effects are associated with this type of intervention?

Common treatments for Esthesioneuroblastoma include surgery, radiation therapy, and chemotherapy. Immunotherapy, such as Bintrafusp Alfa, is being studied for its potential to enhance the immune response against cancer cells. Known side effects of immunotherapy can include fatigue, skin reactions, flu-like symptoms, and gastrointestinal issues. More severe side effects may involve inflammation of organs such as the lungs, liver, and intestines, as well as endocrine disorders. These side effects occur because immunotherapy can cause the immune system to attack healthy tissues in addition to cancer cells.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved immunotherapy treatments for Esthesioneuroblastoma. However, immunotherapy drugs like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways, have shown promise in treating various cancers by enhancing the immune response against cancer cells. These drugs are being explored in clinical trials for their potential efficacy in treating rare cancers, including Esthesioneuroblastoma.

What other types of research exist?

Promising novel alternatives to Bintrafusp Alfa for Esthesioneuroblastoma patients include: 1) Pembrolizumab (targets PD-1), which has shown efficacy in various cancers including melanoma and sarcomas. 2) Nivolumab (targets PD-1), used in multiple cancer types including lung cancer and sarcomas. 3) Avelumab (targets PD-L1), which has shown durable responses in mesothelioma. These immunotherapies have demonstrated potential in enhancing the immune response against cancer cells and could be considered for Esthesioneuroblastoma treatment.

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Checkpoint Inhibitor

Bintrafusp Alfa for Olfactory Neuroblastoma

Phase 2

Waitlist Available

Led By Charalampos Floudas, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status (PS) =<2

Participants should have received at least one line of systemic therapy including a platinum agent, with evidence of disease progression clinically or radiographically

Must not have

Participants who received prior checkpoint blockade therapy and were taken off treatment for serious adverse events related to immuno-therapy are excluded

Pregnant or breastfeeding women are excluded from this study because the study medications have not been tested in pregnant women and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study medications, breastfeeding should be discontinued if the mother is treated on this protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing bintrafusp alfa, an immunotherapy drug, in adults with a rare nasal cancer called olfactory neuroblastoma that hasn't improved with standard treatments. The drug helps the immune system attack cancer cells and stops signals that make the cancer grow.

Who is the study for?

Adults over 18 with recurrent or metastatic Olfactory Neuroblastoma (ONB) that's resistant to standard treatments, including a platinum agent. They must have good organ and marrow function, an ECOG performance status of <=2, and be able to consent. HIV-positive participants are eligible if stable on antiretroviral therapy with no recent opportunistic infections.

What is being tested?

The trial is testing Bintrafusp alfa, an immunotherapy drug given every two weeks for up to 26 doses. It aims to see if this treatment can shrink or eliminate ONB tumors. Participants will undergo various tests and may opt for tumor biopsies during the study.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders which could affect cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I've had treatment with a platinum-based drug for my condition, but it's gotten worse.

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My blood counts and kidney, liver functions are within the required ranges.

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My cancer has returned or spread and cannot be cured with surgery or radiation.

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My hepatitis B virus load is undetectable with treatment.

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I have had hepatitis C but my current viral load is negative.

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I am 18 years or older and willing to give informed consent.

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I am HIV-positive with a CD4 count >= 200, on stable therapy for 4 weeks, and no recent serious infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been removed from immunotherapy due to severe side effects.

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I am not pregnant or breastfeeding.

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I have not had major surgery in the last 4 weeks.

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I have a serious liver condition.

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I am unwilling to receive blood products even if needed.

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I haven't taken immunosuppressive drugs in the last 14 days.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

objective response rate (ORR)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Progression Free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1Experimental Treatment1 Intervention

Treatment with Bintrafusp alfa

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bintrafusp alfa / M7824

2022

Completed Phase 2

~20

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapy, such as Bintrafusp Alfa, enhances the immune system's ability to target and destroy cancer cells by blocking pathways like TGF-β and PD-L1 that tumors use to evade immune detection. This mechanism is crucial for Esthesioneuroblastoma patients, especially those with recurrent or metastatic disease, as it offers a targeted treatment option that can potentially improve outcomes when conventional therapies are ineffective.

Present concepts in the treatment of neuroblastoma.Small extracellular vesicles induce resistance to anti-GD2 immunotherapy unveiling tipifarnib as an adjunct to neuroblastoma immunotherapy.