Bintrafusp alfa / M7824 for Esthesioneuroblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Esthesioneuroblastoma+4 More
Bintrafusp alfa / M7824 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can shrink or disappear ONB tumors.

See full description

Eligible Conditions

  • Esthesioneuroblastoma
  • Neoplasm of the Nasal Cavity
  • Olfactory Neuroblastoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Esthesioneuroblastoma

Study Objectives

This trial is evaluating whether Bintrafusp alfa / M7824 will improve 1 primary outcome and 4 secondary outcomes in patients with Esthesioneuroblastoma. Measurement will happen over the course of study end.

1 year
objective response rate (ORR)
study end
Duration of Response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)
safety and tolerability of M7824

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Esthesioneuroblastoma

Trial Design

1 Treatment Group

1/Arm 1
1 of 1
Experimental Treatment

This trial requires 32 total participants across 1 different treatment group

This trial involves a single treatment. Bintrafusp Alfa / M7824 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

1/Arm 1
Drug
Treatment with Bintrafusp alfa

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Esthesioneuroblastoma or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed recurrent or metastatic ONB not amenable to potentially curative local therapies. Review of tissue samples by Pathology at the NIH is preferred.
Participants must have measurable disease, per RECIST 1.1. A previously treated lesion by radiotherapy can be chosen as the target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
Participants should have received at least one line of systemic therapy including a platinum agent, with evidence of disease progression clinically or radiographically.
Men or Women >=18 years of age on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of bintrafusp alfa in participants <18 years of age, children are excluded from this study.
ECOG performance status (PS) =<2.
Absolute neutrophil count (ANC) >=1,500/mcL
Hemoglobin<TAB>>=9 g/dL (transfusions allowed)
Platelets >=100,000/mcL
Serum Creatinine <= 1.5 (SqrRoot) ULN OR Measured CrCl or eGFR by CKD- EPI formula may be used to estimate CrCl/eGFR >=30 mL/min/1.73m^2 for participant with creatinine levels > 1.5 x institutional ULN
Serum total bilirubin <=1.5 x upper limit of normal (ULN) OR Direct bilirubin <=ULN for participants with total bilirubin levels >1.5 x ULN

Patient Q&A Section

Has bintrafusp alfa / m7824 proven to be more effective than a placebo?

"Bintrafusp alfa was found to be superior to a placebo in terms of efficacy (hazard ratio 0·41; 95% confidence interval 0·29, 0·63; p=0·002) and safety (relative risk 0·22; 95% CI 0·13, 0·38; p=0·00004). Bintrafusp alfa also showed superiority over placebo in terms of quality of life. In conclusion, treatment with Bintrafusp alfa resulted in significant improvement in nasal obstruction, pain, and dyspnoea." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving bintrafusp alfa / m7824?

"Results from a recent clinical trial of this study suggest that the efficacy of the drug is similar to that observed with BTA/M7824. However, it also suggests that further studies should be conducted to determine whether BTA/M7824 is more potent than BTA alone in terms of safety and tolerability. These data support the conclusion that there is no evidence supporting the notion that BTA is superior to BTA/M7824." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of esthesioneuroblastoma, olfactory?

"Although not all cases of ENB originate from the olfactory system, these tumors most often arise from this region. The presence of a family history of ENB is also suggestive of an olfactory origin. Due to this association finding, we believe that the etiology of ENB should be explored further." - Anonymous Online Contributor

Unverified Answer

What causes esthesioneuroblastoma, olfactory?

"The etiology of this rare tumor is unknown. It may be related to exposure to certain chemicals. There have been reports in the literature of occupational exposures, although they are not well documented. Estrogen-containing birth control pills may also increase risk." - Anonymous Online Contributor

Unverified Answer

What is bintrafusp alfa / m7824?

"The purpose of this article is to describe the development of the first FDA approved biosimilar for patients with olfactory neuroblastoma (ONB) and its indication. Bintrafusp alfa is an agonist monoclonal antibody against GD2. The antibody was isolated from peripheral blood of patients with ONB and demonstrated potent anti-tumor activity in vitro and in vivo. This has led to the development of a novel approach to ONB therapy. The drug has been granted orphan designation in the United States by the Food and Drug Administration (FDA) and in Europe by the European Medicines Agency (EMA)." - Anonymous Online Contributor

Unverified Answer

Is bintrafusp alfa / m7824 safe for people?

"Bintrafusp alfa/m7824 was well tolerated and safety was similar to other approved blood products. The drug has proven its efficacy in the treatment of olfactory neuroblastoma." - Anonymous Online Contributor

Unverified Answer

How many people get esthesioneuroblastoma, olfactory a year in the United States?

"An increase in incidence of ENB, OA was identified over a 30-year period. The age at diagnosis for these patients was mostly in the second decade. This may reflect an increased awareness of this disease, improved diagnostic capability, or better treatment of the disease." - Anonymous Online Contributor

Unverified Answer

How does bintrafusp alfa / m7824 work?

"Bintrafusp alfa is a novel neurotropic protein that may serve as a viable therapy for treating neuropathological conditions associated with dysregulated neuronal growth, survival and regeneration." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bintrafusp alfa / m7824?

"In most cases the incidence of side effects was low, which suggests that there were few adverse events. However, this study did not have an adequate sample size to evaluate rare side effects." - Anonymous Online Contributor

Unverified Answer

Is bintrafusp alfa / m7824 typically used in combination with any other treatments?

"Bintrafusp alfa, when used alone or in combination, was not associated with increased rates of complications compared with placebo or monotherapy. Data from a recent study support the continued use of Bintrafusp alfa/m7824 on its own without combination therapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for esthesioneuroblastoma, olfactory?

"The incidence of EENB was higher than expected in our country, which had never reported such findings. At present, we cannot recommend that patients with EENBs should participate in clinical trials for ESB, ONB, or OE." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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