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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying bintrafusp alfa to see how well it works in treating patients with olfactory neuroblastoma.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective response rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1/Arm 1Experimental Treatment1 Intervention
Treatment with Bintrafusp alfa
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,635 Total Patients Enrolled
2 Trials studying Esthesioneuroblastoma
545 Patients Enrolled for Esthesioneuroblastoma
Charalampos Floudas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
649 Total Patients Enrolled
1 Trials studying Esthesioneuroblastoma
500 Patients Enrolled for Esthesioneuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I have never been removed from immunotherapy due to severe side effects.I am not pregnant or breastfeeding.I have not received any live vaccines in the last 4 weeks.My blood counts and kidney, liver functions are within the required ranges.I haven't had cancer treatment or experimental drugs in the last 4 weeks or 5 half-lives, whichever is shorter.I've had treatment with a platinum-based drug for my condition, but it's gotten worse.I am on treatment for bone metastases or high calcium levels and can continue it.My doctor says I don't need immediate brain treatment for my cancer.I do not have any uncontrolled chronic or acute illnesses.My cancer has returned or spread and cannot be cured with surgery or radiation.I have not had major surgery in the last 4 weeks.I do not have serious heart problems.I have a serious liver condition.I am unwilling to receive blood products even if needed.I do not have autoimmune or inflammatory diseases that could worsen with immune-stimulating treatments.I haven't taken immunosuppressive drugs in the last 14 days.I am currently on medication for an infection.My cancer can be measured and has grown after radiation treatment.My brain scans show no worsening after treatment for brain lesions.My hepatitis B virus load is undetectable with treatment.I have had hepatitis C but my current viral load is negative.I am 18 years or older and willing to give informed consent.I haven't had another type of cancer in the last 3 years.I am HIV-positive with a CD4 count >= 200, on stable therapy for 4 weeks, and no recent serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given its seal of approval to Bintrafusp alfa / M7824?
"Limited data exists to support the safety of Bintrafusp alfa / M7824, so it has been rated a 2. Due to this being a Phase 2 trial, there is still no evidence for its efficacy in clinical trials yet."
Answered by AI
Does the current research contain any groundbreaking elements?
"Since 2016, pharmaceutical company Merck Sharp & Dohme LLC has conducted and sponsored research on Bintrafusp alfa / M7824. After the initial study of 829 patients in 2016, Phase 1 drug approval was granted for this medication. Presently, 22 active trials are taking place across 21 countries and 59 cities worldwide."
Answered by AI
How many individuals are contributing to this clinical investigation?
"Indeed, according to clinicaltrials.gov, this study is currently enrolling patients with its initial post date on June 21st 2022 and most recent update October 14th 2022. The research team requires 32 volunteers from a single site for the trial to be completed successfully."
Answered by AI
Is enrollment now available for this medical trial?
"Affirmative. According to clinicaltrials.gov, this trial was initially published on June 21st 2022 and is currently open for enrollment. The research requires 32 participants from a single location."
Answered by AI
Has Bintrafusp alfa / M7824 been studied in any additional research?
"Currently, there are 22 active clinical trials researching Bintrafusp alfa / M7824 with two of those studies in their final phase. While the majority of sites for these investigations is located in Houston tx, 285 locations worldwide have been enlisted to conduct research on this particular drug."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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