Bintrafusp Alfa for Olfactory Neuroblastoma

Overseen By Charalampos Floudas, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 52 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Charalampos Floudas, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Inclusion Criteria

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

Ability of participant to understand and the willingness to sign a written informed consent document

Participants must use effective methods of contraception

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive bintrafusp alfa intravenously every 2 weeks for 26 doses

52 weeks

26 visits (in-person)

End of Treatment

Participants have an end of treatment visit within 7 days after stopping the study drug

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits every 3 months for the first year, then every 6 months for years 2-5, and then once a year after that

Long-term

Regular visits (in-person)

Treatment Details

Interventions

• Bintrafusp Alfa

Trial Overview 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.

Participant Groups

Group I: 1/Arm 1 Experimental Treatment 1 Intervention

Treatment with Bintrafusp alfa

Bintrafusp Alfa is already approved in United States, European Union for the following indications:

Approved in United States as Bintrafusp Alfa for:

• Non-small cell lung cancer (NSCLC)

Approved in European Union as Bintrafusp Alfa for:

• Biliary tract cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+